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Nonclinical Studies Subcommittee of the Hearing

Advisory Committee for Pharmaceuticcal Science December l4,1999


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172:3.19.21: 186~25; 110:7; 112:22; 115:s; 22:ll; 25:9; 28:ll; 32:13, 225:20 astute 2712
188:i; 3; i90122; 211:24; 119:lO; 12013; 123:13; 23; 33:9; 37:23; 38~4; as-it 226:16 Atlanta 6:19
214:ll; 232:1,2,19; 127:21; 134:12; 15623; 4S:l6,16,17; 463; 61:21; ascend 173: 1 ATSDR 267:23
237:22; 244:5,9,13; 158:13; 166:15; 184:lo; 62~24; 64~25; 68~6; 70~8;
245:17; 247:13,19,20,21 , 76:7; 88~10; 93:10,13; aseptic 219:23 ATSM 6S:22
189:9; 204:24; 205:21;
23; 250:6,7,11; 255:2; 206~12; 267~7; 289:13; 105:lS; 111:s; 119:3,3; aside 1565; 183:12; attack 221:12
265:16,20; 266:4,5,1S, 290:3 120:21; 15S:lo; 177:4; 222:20 attempt lS6:22; 159:24;
18; 272~23; 274:6; 286~4 applications 16:20,23; 178~19; 183:ll; 185:7,16; asking-let 285:2 174:4; 1763
animal-to-man 247:16 18:16; 31:20; 38~18; 81:4, 187:13,18,19; 193:18,20 , aspect 57:19; 130:22; attempting 34:l
animals 15:16; 17:25; 15;82:5; 134:14; 160:12; 197:13; 198:14; 210:12; 19620; 207:23; 210:9; attempts 127:3
53:4,13,13,17; 76:21,25; 184:3,10; 199:20; 263:18 223:15,17,19,22,24; 211:25; 219:7; 22020; attend 22:9; 71:l
85:9; 92:5,11; 93:18,20; applied 12:3; 79:16; 224:4; 227~12; 229~17; 281:2; 292:9
230:6; 233:20; 242:9; attendance 122: 15
95:17;98:14; 101:5; 81:23; 96:7; 103:l; aspects 47:12; 51:19;
244~1; 246~8; 247:15; 58:(i; 74:6; 132:22; attention 7:14; 9:25;
lOS:14; 107:13; 11O:ll; 167:ll; 284:15; 289:lS
248~19; 251:s; 252~4; 13:3; 4613; 81:19; 82:6;
116:7,9; 119:lS; 143:9; applies 219:ll 134:22; 207~12; 212:3,8;
254:s; 260:10,11,16; 83:16; 123:24; 2Ol:lo;
144:9; 163:ll; 166~18; 220~25; 271:14
apply 45:20; 114:18; 263~20; 265~22; 267~3; 249:23
16&l, 11; 169:lS; 174:12; assay 16:15; 35:4; 68:23;
120117; 167:11,20; 268:2,10; 269:18; 271:9; attenuation 51:14
192:7; 200:12; 210:23; 169:18; 174:s; 180~14; 214:17; 233:l; 248~25;
285:7,8,15; 2868; attract 97:21
244:lo; 253:23; 254:12; 2491
27615 288~22; 289:10,12,13,15;
260~25; 261:19; 265:lS; assays 16:ll; 123:25; attractive 3019; 31:2
appointing 230:8 295:13,14
277:ll 165:2; 185:4; 233:4 attrition 142:17
appreciate 27:9; 119:1 areas 8:8,23; 9:2,7,10,
annihilate S4:l 21,22; ll:lo, 12; 21:4,4, assemble 11O:lO; 289:4 atypical 62:17,2S
13623; 184:20
announcement 4:12 9,11,17; 22:1,14; 23:24; assembled 231:3 AUC 150:8; 172:2,10
approach l2:2; 35:18;
annual 219:16,17 7613; 144:3; 153:6,24; 45:19; 51:2; 76:7,9; 93:14; assembling 245:2S audience 29:s; 48:11,25;
answerable 203:14 154:20; 15S:6; ls6:14; 94~6; 104:24; 124~8; assess 10:4; 25:24; 78:14; 145:21; 146:4;
answered 44:15;76:16; lS8:23; 164:24; 168~15, 128:lS; 144:7,13; 155:8, 32:14; 3S:2; 63:25; 69:7; 221:5; 223:s; 243:13
18; 182:7; 183:3; 188:23; 12; 158:8,8,22; 182:12; 72:22; 161:1; 162:18;
124:6; 248:2,3,24; 276:lO audiences 31:2S
194:1,25; 195:3; 196:9; 183:20; 185:2; 187:ll; 165:12,19; 166:22; 167:7,
antagonist 63:l !93:12; 194:22; 198:2,4; audit 202:7
197:25; 199:25; 223:s; 16; 171:15; 175:21; August 23:8; 156:20
antagonists 116:16 !03:23; 204:6; 208:4,16;
Z28:7, lo; 229:4,8; 190:16; 198:11;210:8;
antenna 117:s 146:25;247:17;248:1,3; !21:7,20,20,22,24,25; 259:13; 261:21; 272:lO; authenticate 162:3
antibiotic 18719 269~24; 272~15; 283~20; !22:2,11; 223:6,13,15; 273:25 ruthority 28:23; 220:9
anticancer 32:24; 36:3 28S:ll; 287:4,21; 294:18 !26:5; 236:22; 237:ll; nuthorized 205:17
!38:25; 243:s; 244:19,22; nssessable 229: 10
antigen 13:25 approach-to 139:3 assessed 195:19 authors 36:ll
!47:22,24; 251:13; 252:9,
antigens 153:7 approached 194:s 16,21; 254:l; 262:9,10, assessing 33:lS; 34:2; sutomate lS3:2
antipsychotics 62:17, npproaches 7:20; 8:lO; 12;263:25; 266:12,21; 132:21; 133:7; 138:9; automated 84:13; 92:14
25 11:18; 22:24; 23:4; 90:8; !69:11,14; 279:19; 159:6; 164:24; 168~15; Wail 129:21
anxious 77:l 130:16; 165:3; 194:6; !88:17; 289:6,14; 290~9; 197:9; 2OO:lS; 23022; rvailabifity 60:16;
anymore 110:13; 207:8; 196~16; 197:12; 198:lS; !91:3; 292:8; 295:23 235:6; 241:s; 2S9:3 119:13,20; 120:2
104:6; 236:19; 270:6,12 rrena9:24; ll:l, 15; assessment 9:16,18;
238:7 available 29:6; 30:8;
anyplace 98:12 approaching 105:lO; .21:24; 122:s Ll:l, 18; 17:15;25:14; ;7:11;76:6; 119:16;
148:24; 150:17 arenas 29:2 33:lS; 67:lS; 139:17; 127:ll; 128:s; 151:21;
apex 66:20 L56:24; 160~19; 162:6,12,
appropriate B6:25; 17:5; argue 249:s 157:17,19; 191:19;
apical 161121; 164:25; 21~24;22~1; 2614; 44:9, 16; 165:14; 166:2,S, 25;
16S:6 trgument 228:23; 195:13; 199:16; 200:13;
20; 149:12; 167:lS; 168:19,21; 170:16; 174:5; 102:13; 207:17,18,20;
apoptosis 12:ll; 251:3, !65:15 175:9; 195:1; 196:6,6,7,
171:22; 172:18; 173:8; 211:s; 217:24,25; 259:2;
394 182:13,23; 197:24; 201:4; rrisen 220:12 13; 218:16; 235:13,14,17; 268~23
apoptotic 149:15,19,19 222:23; 223:3; 236:24; arising 170:7 236:lO; 260:s; 265:21;
available-I 78:16
apparatus 101:9 !42:4; 243~20; 275~18; arm 224:12 266~7; 278~8
availed 271~13
apparent 207124 Z82:9; 285:9; 289: 17 4rmed 114:5; 133:14 assessments 64:13,16;
163:14; 180:15; 181:9; svenue 263:2
apparently 10614; appropriately 289:19 4rnold 270:2; 287:24
190:23; 197:14,19; sverage 73:9
268:24 ~pprovabilfty 138:16; around 5:25; 19:13; 2S:4;
139:l 278: 24; 279: 20 avoiding 211:21
appear 44~7; 89:20; !6:14; 27:3; 32:19; 43:ll;
npprovable 25:4 73:21,23; 84~4; 86:5,6; assist-and 1393 aware 5:11;8:18;9:9;
13623
102:9; 106:25; 141:15; assistance 161:23 267:12
appearance 4:1S, 21; npproval45:12; 69:2;
71:19;72:13; 129:lS; 173:20; 178:5; 179:ll; assists 138:s Bwareness 263
8S:8; 170:s
139:ll 183:13; 237:l; 262:21; associated 30:9; 170:6, away 33:22; 44:9; 121:3;
appeared 104:ll;
145:16; 174:16 approved 142:22; 171:13; 279:17,18,21,22; 10,14; 233:22 I :212:lO; 23S:l; 245:22;
S6:11; 205:lS iSO:l, S,21; 285:21 assume 60:21; lS3:12; !76:8; 291:21
appears 36:14; 150:20;
lpproximatefy 169:ll array 105:20; 126:22,23 193:7; 208:ll rwful 143:6; 233:25;
169:3; 269: 1
arrays 15:9 axmed 48:24 !39:5; 245:19
applicability 129:25 ~pril14617
uchive 108:12; 127:lS arterial 174:2, S rssumption 245:2 axis 55:3,5
applicable 13~8;
141:12; 164:10;226:6,7 uchived 113:4 irtery S7:13 assurance 209:10,13,
applicant 206: 11 uchiving 13025 article 553 !2; 210:14; 217~9 I3
application 17:13; 31:9; uea 8:6,7,16,20,23; articles 46:9 assure 273:13
46:10;73:16;79:24; k16,18,24; 11:14; 12:16, uticulate 183:17 nssuring 13:23 f3 37:14; 41:22; 42:4,20;
81:20,2S; 90:4; 93:12; .7,19,20; 16:s; 17:6; / Artificial 9:6; 66:20; 1 AST 10:9; 19:21 I 4L3:15,16; 127:23

Miller Reporting Company (202) 546-6666 Min-U-Script@ (3) animal-to-man -B


Hearing Nonclinical Studies Subcommittee of the
December l&l999 Advisory Committee for Pharmaceutical Science

baboon 65: 10 bear 93:2 biases 292:s 23; 146:1O,lS, 18,19,22; blood-brain 37:24; 70:2;
big 49:18;60:14; 111:ll; 1149:2,S, 13; 151:8,23,24; B5:17; 88: 18
back 7:lS; 8:l; 20:22; beat 107:14
%2:21; 48:19; 75:25; 12619; 140:1,7; 266~22 lS2:12; 153:1,16,23; blow 105:13
beauties 87:19
78:18;87:16;98:23; LS4:21; 155:24; 156:6,7, blown 97:3
Beautiful 38:12; 81:lO; bigger 250:16,19
106:1,7,14,17; 109:16; 25; 160:11,14,21; 161:1,
9S:16 biggest 248:23,23 blue 42:24
118~15; 120:20; 134:21, 11,17; 162:1,2,9,15,18,
beauty 241:3 bilateral 5622 24; 163:2; 164:10,16,17; blurs 32:2,6
24; 135:2; 147:17; 202:21;
became 9816; 102:17; Bill 63:14; 111:9,12 165:9,19,22,25; 166:3,8, board 133:21,2S; lS6:12
212:2; 22024; 227:23;
251:23; 252:2,S; 253:lo; 1586 binder 42:13 16,22; 167:6,10; 168:19; bodies 1625; 149:19
2SS:20; 260:19; 264~7; because-or 277:23 binding SS:ll; 62:21; 169:15,17,22,25; 170:4, body 32~20; 369; 37~22;
271:ll; 275:24; 278:4,14; become 49~24; 1767,s; 63:8,16; 6621; 77:2S; 1s; 171:3,17,20; 172:15, 41:24;47:17,18; 5021,
279:4; 282:5; 284:7,19; 233:21 7813,s 20; 173:14,17; 174:5,24, 23; 56:l; 59:6; 94:2S;
287:24; 29O:lO; 291:l; 24; 176:11,16,25; 177:9; 142:3,14; 165:25; 200:2;
becomes 77:13; 187:l; binds 61:19; 62:22; 66:12
295:21 183:20; 220124; 223~22; 281:12
233~22; 2784 Bio 6:13,13; 22:6; 242:9,
back-summaries 224:2,3,4,18,18,19,20, bogged 12S:l
Befloxatone 61:17; 62:2, 14; 244: 14 22; 225:4,6,6; 226:2,9,
202:16 boil 128~17
4,5,15 bioavailability 187:23; 25; 227:8,18;228:2,10,
backbone 231:5 began 23:ll; 58:22; 190~2s; 191:24; 272:11, book 292:23
15; 229:9; 230:5; 231:25;
background 7:s; 20115; 83:17 13,21; 273:lS booting 93:s
232:3,7,9; 233:11,20,21,
174:17; 272:l begin 7:16; 49:s; 67:9; bioavailable 187:24; 24;,234:12,16 235:6,8, boots 93:3
Backgrounder 79:10,10 77~2; 109:22,2S; 203:6; 191:2,4; 192:2 l&13,22; 236:3,6; bore 97:24,25;98:1,18;
backlog 120:6 252:4; 253:ll; 257:22; biochemical 12:3; 19:17; 237:20; 240:16; 241:12, 99:21; 100:2
backup 122:23 268:4; 291:12 lS9:7 14,lS; 242:20; 243:5; born 19:16
backwards 272~8 beginning 5O:lO; 81:7,8; biochemistry 14:14; 246:19,19; 24719; 248:11,
97~20; 11O:lO; 118~16; borrowing 119:21
bacterial 217:ll 19:14,24 12; 249:7,8,11,24; 250:1,
221:lS; 222:21; 283:15 21; 2Sl:lO; 252:10,12; both 11:s; 25:21; 26:4;
bad 47:19; 164:13 ” Biofluids 166:24; 168:5
beginnings 77:7 253:22,2S; 254:ll; 255:2, 36:15;43:11; 54:16;
badge 176:7,7; 233:21 Bioinformatics lS8:19 7625; 8017; 91:12;
begun 70:4; lOS:6 15,18; 262: 11; 264:4,23;
balance 14:12; 27:12; Bioinformation lS8:20 28618; 288~22; 289~5; 93:18;96:15;98:10;
63:l; 72:4; 989 behaving lo:21 biologic 199:21 107:19; 125:12,16;
290:9
balk 89:s behind 165:6; 291:12 biological 9:2; 13:23; 130:24; 131:5; 144:s;
Ibiomarkers-does 2261
bandwidth 127:17 beholder 189:ll; 274:lS 37:lO; 83:23; 92:7; 162:7; 14S:6; 161:11; 163:21;
IBiomedicine 95:25 178:12,14; 179:15;
bank 210:10,11 beings 192:8; 258:4 16S:4; 167:l; 168:24;
213:9;220:15;242:11; IBiophotonics SO:6 180~25; 204:5; 22S:lO, 25;
barbecue 109:ll; 112:14 belabor 217:21
259: 14 Ibiophysics 108:16 226:2S; 235:9; 237:18,18;
barely 36:21 belongs 57323 24610; 254:12; 269:14;
biologist 104:22 Ibiopsies 141:19,20,23;
barrier 37:24; 70:2; below 104:16; 13820; 16619 279:23; 285:7; 286:18;
170:14; 173:14,17,19 biologists 108~11 289:12; 291:6
85:17; 88:8,19; 121:23 Ibiopsy 65:17; 83:12
beneficial 181:23; 250:4, biology 97: 18; 110:8; bottom 5O:l; 163:22
barriers 203:16 Ibiotech 214:6
9; 271:14 139:23; 140:7,21; 169:10,
base47:l; 154:14; Ibiotech-derived 217:23 bought 101:19
benefit 39:6,21;45:12; 25; 249:s; 267:ll
lS5:20; 292:12 Ibiotech-type 210:9; bouncing 98:s
47:6; 60:22; 67:25; 139:l; biomarker 14:6; 2O:lO;
Based 4: 16; 83: 16; 22:11,13; 59:18,21; 215:s bound 42:lS; 162:s
144:4,16; 153:lO; 154:20;
116:18,20,24; 123:7; 67:lO; 68:3; 138:s; Ibiotechnology 123:19 boxed 240:6
163:25; 178~11; 264:1,9;
131:5; 133:22; 163:lO; 139:23,2S; 140:17,18;
266:22; 269~13; 290:20 Ibiotransformation boy 99:3
164:5; 172:lS; 173:7; 141:10; 142:2S; 144:2,8,
181:19; 187:8,2S; 206:12; benefits 108:4; 177:24; 166:7 brain 38:4,5,6; 41:2S;
178:15; 183:lS 20,21; 145:6,22; 146:13; bit 14:24; 15:lS; 20:12; 42:1,20;43:14;61:11,20,
208:20; 209:3; 22618; 147:4; 148:5,8; 149:22;
242116; 24S:l; 248:s; benign 164:22; 173:3 22:22; 23:7; 47:9; 49:8,14; 21,23; 75:4; 78:9,9,12;
150:16; 153:12,21; lS4:2; 82:14; 85:14,18,19; 86:1,
261:lS; 272:13; 275:7; best 2614; 74:s; 75:3; so:lS; 56:12,1S; S9:lO;
164:9,20; 1665; 170:7,9, 61:15;70:18;74:8;76:23; 12; 87:5,16; 88:s; 89: 19;
277:11,14 84:20; 120:3; 129:S, 10; 12,14,23; 171:12; 172:7;
86:19; 97:4,9,14; 98:21; 109:21; 127:6,9; 265:17
baseline 42:20; 43:2; 134:s; 159:12; 172:lO; 174:20; 175:19; 1762;
44:4; 61:22; 133:6; 23014 176:l; 179:6; 195:24; 101:25; 105:13; 109:ll; brains 87:22; 127:s
225:3; 228:21; 231:4;
198:3; 223:5; 233:5; 154:l; 184:21; 188:8; breadth 65:2
basic 19:17; 98:s; 141:l; 232:4; 234:ll; 235: 16; 192~11; 222:20;264:12;
169:25; 209:2 241:12; 248:2; 253:19; 236: 15; 239:7,10; 241:2, break 47~8; 78:17,19;
260~9; 262:22; 286~17 274:10,18; 283:15; 9619; 220:23; 221:l;
basically 54:ll; 82:20; 8; 246:23,24,25; 247:17;
beta 66:6 290:25; 294:1,9; 295:21 29S:lS
85:12; 89:lS; 91:24; 248:3,25; 249:5,9;
better 12:7; 19:7,11; 250:24; 251:4,9; 253:20; bits 13O:lS breaking 72:l; 176:13
104:2; 115:14; 1861;
191:2; 192:13; 258:lO; 47~2; 83~2; 92:s; 110:17; 2S4:3,9; 273~23; 278~7 black S:21 breaks 85:17; 88:18
295:24 113:19; 125:4,5,5,6; biomarker-well250:23 blacksmith 48:17,19 breath 101:12; 106:4,6
basis 23:4; 53:14; 67:23; 133:6; 142:s; 155:3; biomarkers 9:25; lO:l, 4; blindly 147:13 breathe 107:13
75:2; 129:8; 156:22; 157:22; 160:9; 162:8,1’S, 13:3; 15:16,21; 16:4; block 63:4
20; 172:17; 174:4; 179:1; breathing SO:24; 64~2;
178:6; 192:ll; 201:2; 17:14; 18:1, lS,21; 19:19; blockade 63:19 lOl:ll, 11; 103:19;
206~24; 278~15; 286:4,4 180:15; 192:16; 1987; 45:8,13,17,22; 79:lO;
226:8,22; 238:17; 24018; blocked 37:20 106:18,2S
batches 2165 134:22; 136:12,15; 137:2,
246~20; 247:10,13; 248:3; blocking 63:5 brevity 128:13
battery 239: 13 2,3,5,5,7,10,11,12,13,
253~22; 268:lS; 279:13; 15,19,22; 139:2,7,14, blocks S4:23 bridge 17:24; 18:2;
bezillion 250: 17 286:22 19,20,21; 14o:s, 13,15, blood 18:8; 34:19; 3S:ll; S2:24;93:10; 115:lo;
be-it 148:lO beyond 60:4,4; 75:16; 25; 141:3,6,6,14; 142:5, 51:3; 64~18; 7616; 80:20; 141:1,1; 156:lO; 230:24,
be--not 202: 15 86:9; 268:s 8,10,15,20; 143:1,23; 88:7; 141:15; 166~20; 24; 286~22
bead 153:5 bias 64: 16 I 144:8,16,23; 145:9,20, 168:s I bridging 17:23,23;

baboon - bridging (4) mm-U-Script@ Miller Reporting Company (202) 546-6666


Hearing
Nondinicd Studies Subcommittee of the
Advisory Committee for Pharmaceutical Science
December 14,1999
-
to; 159:5,11,13,15,17, C:arefuf 42:22; 123:12; C ell9:3; 10: 18,19; 1~6,
52:22; 53:21; 141:9
brief 161:4; 213:8,9; C [8,23; 160:7,24; 162:3;
166:S, 18,21; 167:ll;
199~25; 229~17; 232~20;
214217;247:s; 249~23
24,25; 12:1,9,11,13,22;
13:s; 14:12,13; 18:12;
214:1,13; 215:25; 217:2, 19:2,11,19,23; 33:l;
171:13,14,19; 177:23; C:arefuliy 55:2; 72:22;
14,19; 218:4; 284:11,12, : 127:23 34:19,19; 54~7; 88:23;
179:1,6; 180:15,21; eL8:ll; 117~10; 154:17;
2s :admium 250:25 149:16; 166:21; 167:18;
181:8,10,18; 182:lS; 169:16; 229:21
briefly 7:16; 131:lS; :alculate 173:21 183:14,16,24,24; Wi:S, 2 lO:lO, 10
C:arotid ~7:13
lS62,lO ;; 186:lO; 187:14; 189:13; C ells 10:s; 11:22; 12:l;
:all4:2; 10:7; 17:22; C:arried 63:24; 277:16
bright 63:17; 10015; 13:18; 70:24; 87:3,8; 190:25; 191:20,22; 8:9,12; 19:3,4; 367;
102:21 C:arries 50:15
17:l; 14618; lS1:9; 192:20; 193:5,7; 195:3, : 5:22,23; 66:13; 141:1S,
bring 9:10; 14:20; 22:11, 25; 196:s; 197:11,14,16, C:artoon 54.10; 63:3; 17; 149:7,19; 150:13,16;
s2:17; 176~13; 204:19;
17;82:6; 112:21; 133:14; !07:6; 209:17; 222:7; 18; 198:17,23; 200:4,16; I.67:14 166:20; 174:s; 235:8;
14621; 154:lS; 163:3; !43:13; 257:10,12; 103:25; 204:ll; 209:15; :ase 15:13; 1612; 39:17; 2:57:15
185~24; 240~24; 248~8; !75:10,11 111~5; 218:16,19; i i2:9; 49:24; 53:23; SS:lo; C:ellular 10:7,11; 46~11;
256: 18,22; 273: 11; 294:s Zallaway 618 z22:10,15; 2268; 228~5; 5i&l1;65:6;71:1,11; 109:22; 161:25; 167:17;
bringing 7:ll; 168; 17:l; 229:16; 232:3; 234:3,13, 7‘4:2S; 7620; 77:l; 78~16; 259:13,16
:alled 35:25; 45:s; 81:17, EI7:21; 109:21; 110:19;
111:4; 146:20; 182:2; !o; 1Ol:lS; 122:20; 24; 235:9; 237:19,24; C:ement 22821
222:17,22; 295:23 238:12,14,23; 240:s; I.33:21,22; 165:21; 167:5;
.49:11; 174:l; 208:12 C:enter 4~9; 65; 16:2S;
242~14;243:2S; 245:7,15, 1.69:8; 171:ll; 172:ll;
brings 287:lO :alling 110:4; 24624; 8;2:1; 92:20; 98~4; 158:20;
19; 246:4,13; 247:6,22; I.74:6,14,18; 175:6,11,
broad 76:6; 1381; !57:13 177:5; 185:2; 194:22;
151:20,22,2S; 252:10,13, I.I; 190:3; 204:5; 227:13, 195:17; 221:21
lS8:21; 180:7; 184:2; :ame 32:7; 62:19; 99:16; 1.3,1S; 26s:20; 2661;
16,20; 253:7,19; 254~8, Cienters 2814; 63:21;
204:8; 237:16 !39:3 2!68:20
25; 255:6,19,20; 256:18; 158:18
broad-based 263: 17 :an 7:12,19;9:22; 10~10; 257:s; 258:20,22; 25916, C:ase-by-case 129~8;
C:entimeter 1OO:ll
broader 94:5; 110~24; .2:10; 14:4,5,18,2S, 25; 14; 260:1,14,15,20; I.92: 11; 19S:l; 235:24;
194:23; 288:22; 289:4; i !66:24; 285: 11 C:entimeters 98:19,21
.5:2,4,8,9,24; 16:8,16, 262:21; 263:1S, 25,2S;
290:8,13; 296:14 ~9,25; 17:4; 18:3,4,9; 265:12,24; 266:3,4,15, c:ases 25:6; 26:12; C:entraf 42:25; 5~6;
broadest 164:16 .9:3,6; 20~23; 21:2,5; 17;267:1,8,21;268:15; I123:13; 139:16; 142:21; 14:13,16; 55:s; 60:20;
broadly 156~21; 194:23; !3:23; 25:24; 2617; 28:6; 269:7,7; 271:1,17; I143:14; 147:24; 151:1,2; 2;1:13; 127:25
248:ll !9:1,7,17; 30:13; 32:s; 27S:lo; 276:1S, 17; 277:s; I152:10,11; 179:10,15; C:ents 111:21; 112:lS

brochure 75:13 13:S,24,2S; 34:19; 35:2, 278:22,23; 279:3,10,19; 1181:4; 187:7; 188:9, lo; C:erebellum 61:21
i; 36:2 1; 37:6,11; 38:7, 280:17,18; 282:8,13,16; 1191:17; 196:3; 218:14; C:ertain 17:14;49:12;
broken 291:21 !2; 39:22,24,25; 40:3; 283:l; 284:1O,lS, 16,22; ;!26:22; 238:19; 243:17; 7‘1:21; 128:lS; 137:7;
bromobenzene 117:13 i2:2S; 43:2; 45:&l, 2; 285:12,21; 287~3,s; ;!65:5,24; 266:13; 268:lS; 1.43:5,19; 147:lS; 150:6;
bronchial 142:4 i7:10; 49:9; 51:2,12,16, 290:14,1S, 25; 291:13,17; ;169:6; 273:17,19; 275:17 1.66As; 188:24; 205:23,
bronchoafveolar 16624 17; 52:9,19,24; 53:8,1S; 292:16; 293:7; 29S:l, 2,12 t:ast 144:3 i !3,23; 274:2; 278:2,3
Brook 41:19 j4:4,5,6,7;55:7,22,22; cancer 9:3; 12:14; 35:22; t:ataloging 91:22; 108: 11 c:ertainly 28:21; 41:3;
j6:1,6,25; 57:3,17; 58:4; 5s:lS; 69:3; 75:2; 187:2;
Brookhaven 41:19 t:atch 140:23; 257:9; 4L6:13,18; 68:15; 70:9;
j9:4,S, 12,13; 61:2,17, 239:7; 249: 15; 264: 18
brought 83:16; 147:25; 1258~2;291:13 7‘4:25;90:18; 120:1,8,10;
19,22; 63:14,25,25; 64:4 candidate 29:25
201:lO; 243:22; 244~2; t:atchup 291:17 I124:19; 129:21; 134:19;
19;65:11,13,15;66:1,2,
248:24 candidates 181:l; 2568 1164:13; 188:13; 193:ll;
ls,20; 67:3,13; 68:6, lo; t:ategorical218:14,20
candle 43: 14,15 !18:11;219:24;248:15;
Brown 6:19; 93:l 70:9;71:5,8;73:12,13; t:ategories 59:12; 171:17 !53:20; 25615; 258:16;
browser 127:12 76~23;77:17; 78:8;8O:lS, cane 136:20 Izategory 34:3; 60:3,4; !66:25; 269:11,12; 281:2,
Bruce 124:lS; 239:3 17,18,23; 81:s; 82:9; capability 261:21; 263:6 246:25 16; 283:13; 28S:3
brute 131:13 33:l; 84:4,8,15,15; 8S:6, capable 83:6; 178:14 1Cates 10022
7,9;86:3,11,13,14,23, :ertainty 138:7
build 93:9; 117:s; 126:4; capacity 120:3 tcause S8:17; 165:21; :ertificate 215:2
24; 87:3,7,8,9,2S; 88:1,
159:9; 160:6; 178:12; 5,16,17,24; 89:12; 9212, capture 103:lO; 117:lo; 170:9; 202:2; 217:lO; sertificates 214:23
180:3; 184:6; 230:22; 3,7,8,11,12,12,13; 152:lS 238:20,20; 250:25; 251:4:
certification 214:21
263:lO 33:15;95:19,21;96:13; capturing 46:12; 178:15 277:22
Building 5:7;47:1;93:15; cetera 97:l; 123:12;
38:lo; 100:4,8,10; 101:2 carbo-11 S1:21 /cause-effect 154~9
230:15; 240:21; 242:12,
126:3 14,23; 104:6,8; 1OS:lO; carbon 29:17; 37:15 Icaused 58:lO; 63:19; 12; 272:19; 274:14
builds--one 132:4 106:1,9,13; 108:16,21; carbon-l 1 36:6,14,17, 175:14; 21S:lS
CETP 69:6
built 11S:lO; 119:4,15; 109:2,5,9,13,14,22,24; 21; 37:s,h, 18; 42:lS; causes 150:5; 168:16,
153:17; 154:11;238:3 110:14,18,20; 111:17,1t Chair 27:s; 223:7
66:25 17; 17S:2
112:1,17; 113:1,16,24; Chairman 27:19; 48:6;
bulbourethral65:ll carcinogenesis 12:17 causing 171:9; 234:13
114:7,23; 115:22; 117:6, 4912; 72:25; 93:4
BUN 10:13 carcinogenic@ 239:17 Caution 218:9
14,22; 118:6,10,11,22; challenge 102:lO;
bunch 128:3; 24S:lS; 120:9,17,18; 121:ll; carcinoma 17O:ll CAVAGNARO 6:12,12; 107:12; 110:24; 122:3;
294~3 122:1,5,8,25; 126:2,7; cardiac 20:5,6,9,11,14; 123:s; 131:6; 132:14; 132:16; 180:7
burden 271:6,7 127:1,8,9,11,13,1S, 16, 66:18;96:11; 100:8,13; 226~4; 230~9; 24216;
challenges 178:2; 182:s
burgeoning S9:2; 18O:l 17; 129:15; 130:9; 132:3, 106:1; 113:12; 144:20; 272~2; 27411,s; 286~20;
291:lS challenging 107:lS
burning 43:14; 78:lS 3; 133:6,20; 134:16; 171:14; 174:25; 175:6,16;
135:2; 138:1,2,15; 139:21, 228:21; 238:21 caveats 261~24 chamber 96:15
business 26:15; 111:13; chambers 96:14
179:24; 278:5 20; 140:23; 141:16,16,1’ 7; cardiotoxicity 147:4; CBER 22:4; 2Ol:ll
/ 142:10,17,21,22; 143:7: champion 124:7
busy 137:21 240:21 CDDI 291:19
145:13; 147:9,12,14; CDER 22:4; 31:s; 79:16; chance 293:25
button 5:21 cardiovascular 96:9
149:3,18,23; 151:23; 201:11; 224:12; 243:14 chances 249:12
buy 12:11;43:22; 122:7 152:3 , 4 P4,5,8,18; 153:L4 care 4:9; 102:6
I celebration 111:12 I change 11:5; 15:4; 34:5;
buying 24514 5,23; 154:3,11,14; 155:!3, career 31:24; lSS:5

mer Reporting Company (202) 546-6666 fin-u-script@ (5) brief - change


Hearing Nonclinical Studies Stibcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science
chips 15:1,8 27:21; 28:22; 3O:ll; 35~6; cognitive 50:21; 128:16; I comments 24:s; 28:16;
j7:23;45:1;87:15,18;
z&22,24; 113:ll; 191:15; chloride 117:14 39:1,24; 40~2; 44:8,20; 129:2 47:24; 73:4,6; 132:13;
203:7; 219:21; 220:2; choice 18021; 238:9 45:12,15;47:7;49:2; cognizant 125:13; 219:3; 223:4,9; 227:23;
271:3; 273:6; 283:25 5O:ll; 52:20; 53:1,2,8, 146:25; 232:24; 233:9; 230:9; 232:22; 235:14;
choices 243:20
changed 19:22; 3517; 11; 54:18;60:6;64:5,10; 234:23 291:19; 295:2S
choose 129:s; 144:5,8; 67:8,23; 6814,7; 69:1,4; commercial 25:12,13;
37:11;79:11; 142:ll; coil 118:4
163:24; 169:ll; 171:21; 70:1,6,18;72:21; 7615,
219:10,19; 269:25 coils 98119; 117:5,11,12; 120:6; 122:7,8; 163:2S;
179:6; 249:ll 15,20; 77:2,3; 7812; 80:4,
changes 37:18; 83:21; 118:4,8,9 182:3
choose-there 287:3 12; 81:4; 86:6; 93:10,14;
84:19;91:4; 141:17,22; coin 37:lO commercially 119:16
142:14; 149:24; 166:5; choosing 287:16 94:24; 98:2,8,12; 101:20;
103:9; 112:7; llS:20; coincident 54:2 commit 274:19
167:8; 168:s; 185:5,17; chore 251:lS
116~13; 119:22; 121:6,24; coined 181:Zl committed 221:21
204~2; 219:15; 220~4; chose 55:13
129:14; 138:9,11,17; collaborate 8:9 Committee 4:4,17,23;
235:7; 259: 15; 273~6 chosen 19:19; 39:s;
89:lS; 162:s; 221:19; 141:19,20; 142:18; 143:4, 6:8,11,16,20;7:6,22,23,
changing 178:lS; collaborating 113:20;
222:l 15; lSO:6; 154:3; lSS:l, 3; 24;8:l,s; 11:13; l&6,22;
195:lo; 198:2,18; 220:15 144:17; 267:14
162:2; 169:19; 176:17,19; 20:22; 21:14,14,16,23;
channels 369 chronic 90:s; 91:lo; collaboration 23:12;
177:1,17,18,22,24; 23:11,12,14,15,19;
chap 5618 179:10,13 50:3; 114:4; 124:13;
178:23,25; 179:14,17,19, 24:23; 26:6,25; 28:l; 31:6,
Ciphergen 152:17 19; 180:6,20; 181:9,19, 134:8; 144:7; 145:21; 6;75:8;90:3;94:1;111:6;
chaperones 13:21
circular 141:16 177:9; 224:11,1S; 267:22 118:20,22; 119:7; 122:13,
characteristic 15:12 21; 182:6,19; 183:1,10,
characteristics 12:22;
circulating 141:14,1S 18,24; 184:11,14; 185:12; collaborations 8:14 19,22; 123:l; 124:25;
29:15; 30~4; 38:22; 80:13; claim 218:19 186:4,15,23; 187:2,13, collaborative 8:lO; 126:2,17; 128:7; 132:5,6,
183:8; 199:2; 2067; claims 2619; 28:22 22; 188:12,21; 190:11,12, 21:23; 23:4; 24:2; 28:7; 13; 134:2; 136:24; 153:15;
213:lO; 216:2 clarification 280:9 12; 191:12; 193:22; 46:6; 153:16; lS4:20; 175:25; 178:5; 180:9;
194:lO; 196:20; 199:12, 159:16 181:25; 182:ll; 183:17;
characterization clarified 201~6 18; 201:5; 202:2,3, 11,21;
161:lS; 183:l; 261:20 collaborators 22:3; 24:l; 184:9; lSS:S, 15; 222:3;
clarify 79:8; 183:17; 203:23; 208:5,6,13; 226:2; 230~8; 231:16,17;
characterize 74:lO; 28:13
261:14; 275:14; 289:22 209:20; 210:6; 211:23; 233:9,13,15; 240:7;
89:ll; 198:23; 199:l; clarifying 276:s colleague 9SA2; 99:14
215:14; 220:s; 230:16; 243:4,16,16,18; 246:7;
261:s; 278:16 234:20; 2359; 240: 19; colleagues 30:14,15; 248~8; 250:20; 251:14,23;
clarity 183:12; 278:25;
characterized 42:ll; 244:17; 252:21; 268:19, 41:18; 53:5;61:16;98:1S; 252:2,5,7,14; 253:3,9;
280:1,17; 282:2S; 283:2
90:17; 113:5; 183:s; 22; 269:23,25; 270:4,7, 104:15; 114:12; 127:2; 254:23; 255:20,23; 257:4;
class 5:1; 13:20; 14:7; lS7:lO; 183:lO
21O:lo; 213:ll; 215:s; 20:15; 131~56; 170~25; 12,16; 272:10,20; 273:10, 263:15,24; 264:3; 266~6;
261:21,22 16; 274:12; 278:13; coffect 128:21,2S; 269:9; 276: 14; 279: 1;
226~20; 227~25; 233~22;
characterizing 133:lO 279:25; 282:ll; 286:23; lS2:19; 204:3; 257:22; 281:14; 283:l; 284:12,12,
2669
charge 21:18,24; 24:7; 287:l; 289:13 273:16 25; 285:18; 28616; 288:4,
classes 10:7; 11:20,21;
118:16; 137:l; 24O:lS; clinically 261; 147:18, coffected 133:24; 9; 289:22; 290~22; 291:19,
14:4; 17:25; 18120; 20:19;
269:15 20; 152:14; 194:lS; 198:s 187:18; 265:19 20,23; 292:3,11; 293~5,
32:17; 170:23
charter 28: 17 clinicians 262:7,17,24 collecting 26S:lS 11; 294:11,19; 295:12,22;
classic 12:2 296:6,6,22
chasing 241:l clinics 252:13 collection 45:2S; 74:14;
classical 61% committee’s 47:9
chemical 19:l; 176:2; Clinton 116:12 159:lS; 185:s
classification 32:s committees 17:5,7,10;
179:5; 180:19; 181:19; close 108:l; 117:9; collective 264:5
clear 38:19;45:5; 50:13; 265~25
208:25; 209:4; 213:9; 136:4; l&4:8; 228:23; collects 186:ll
Sl:l; 5624; 129:3,7; common 14:lS; 30:20;
216~18; 275:2,4,18; 138:13; 158:6; 161:s; 252: 12; 293:s College 6:19; 122:18,20
277:lS closely 162:6; 273:15; 51:5;71:21,22; 116125;
202:19; 206:14; 208:14; collegial 176:15
chemically 192:14; 275:7 158:23
255:2S; 262:19; 271:5; Collins 27:1S, 18,19;
209:9,23 272:7; 275:2S; 276:12; closer 124:13 commonly 54:s
47:lS; 50:7; 53:s; 6O:lO;
chemicals 112:19; 283:19; 284:16; 287~24 81:14; 118:14; 168:22; communicate 184:4
closest 172:13
159:7,24; 195:24; 276:5 cleared 21017 closure 220:2 286:21; 287:9 communicated 285:23,
chemist 114:19; 207:22 Clearly 28:4; 42:25; color 15:4;40:16;42:21 24
clozipene 62: 19
Chemistry 6:19; 11:2; 65:12; 1Sl:lS; lS3:lO; column S7:24 communicating 276:15,
clues 162: 1 25; 289:25
28:23; 52:4,6;73:11,11, lS7:lS; lS9:2; 191:13; combination 149:6;
17,19; 111:21; 112:15,20; clusters 54:7 communication 157:6;
192:21; 194:6; 195:21; 214:23; 2S9:7
142:13; 154:3; 178:21; 197:s; 199:4; 203:23; cm 102:15,16 158~17; 163:13,15; 203:l;
combinatorial 178~21
190:12; 201:22; 204:18, 205:2; 231:21; 237:13,23; cm2/second 102:12 267:3,15; 285:23; 287:18;
20; 205:3; 206:3,22; 245:15; 249:25; 250~2; comfort 148:12 289:21; 290:3
CMC 204:18,19,24;
207:2; 209~2; 212:6,8,21; 264:2S; 266:13; 2677:7,17; 206:7; 207: 18; 2 18:24; comfortable 35:17; community 110:8,24;
220:19; 2711525; 275~22; 273:7; 289:3; 291:lO 219:7; 278:l; 279:18; 170:13; 262:25; 271~22; 122:4,17; 126:6,2S;
281:l; 285:7 clever 47:4; 97:19; 280:2 296:7 146:5; lS7:7; 268:5,7;
chemists 97:21; 205:lO loo:21 CNS 173:4; 242~24 comfortably 173:17 289:25
chemokines 167:lO clinic 18:4; 35:5; 38:20; co-chairs 243:lS coming 69:20; 144:2; companies 40:12;
chemotherapy 69:13 62:23; 76:14; 92:s; 93:lS; 147:s; 249:19; 281:lS; 116:17; 121:5; 123:15;
co-sponsored 146:17
143:lS; 1SO:li; lS1:3; 296:21 156:15,16; 157:15; 203:4,
Chen 102:23 coalesce 294:5
154:lS; 169:16; 232:6,14; comment S:17; 92:2S; 9,12; 241:7; 270:15;
Chevy 128:6 coalescence 49~22 271:13; 275:23,24; 279:4;
242:23; 247:17,21; 250:7, 219:2; 222~6; 226:4,24;
childhood 147:20 12,15; 254:13; 255:3; Code 199:lS; 20023 227:17; 229:l; 237:7; 280:10,18; 284:21
children 127:19 273:2 coefficient 102:11,1S; 243:14,19,21; 24611; company 101:18,19;
chip 14:24; 16~1; lS2:17 clinical 6:9; 11:2; 15:17, 104:13 288~2; 293:21 119:12; 13O:l; 150:6;
chipping 24522 I 19; 23~2; 25~20; 26:lO; coffee 96:19 I commentary 188:22 / 160:2; 196:4; 215:l;

changed - company (6) Min-U-Script@ Miller Reporting Company (202) 546-6666


Nonclinical Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999
274:24; 275:s; 281:7,10 compromised 142:3 :ongruent 168:2; 169:3; continued 60:21,24 :orrelates 264:21
comparable 172:l; compromising 283:12 171:l Continuing 71:3 :orrelating 54:12,15
233:7 computer 25:lO; 93:5, :onjunction 70:23 continuously 40:22 zorrelation 53:lS; 59:25;
comparative 53: 11 25; 97:20; 127:16; 152:9 :onnect 134:2 continuum 67:s 147:11; 172:13; 235:7
compare lS2:20 concentrating 21:5 zonnected S9:17; contraction SO:18 zorroborate 93:20
compared 9~6; 149:17; concentration 33:16; 134:14; 1569 contralateral 58:11,18 :orroboration 177:3,10
188:l; 291:9 34:lS; 54:19; 158:12 consciousness 30:2 contrast 87: 1‘5, 15, 18; cortex 88~15
comparing 67:4; 91:17; concentrations 33:2; consensus lS7:22; 91:4; 108118; 114:24 cost 24~24; 64:lS; 141:2,
96:3; 108:6; 152:s; 27621 36:3; 61:20; 84:2,4; 147:6 222:15; 251:6; 252:3,8; contribute 28:ll; 67:lS; 3; 163:1,23; 164:2;
comparison 89:9; 92:6; concept 23:20; 24: 14; 253:15; 288:17,21; 289:3; 68:15;79:S; 120:12; 17622; 179:15,21; 181:5,
260:21 38:lS; 137:l; 14621; 296:4,16 271:1,10 j; 245:19; 261:25
comparisons 167:19 lS3:20; 181:10, 11; 263:l consequence 106:16 contributed 188~14 East-effective 264:19
compartment l&10; concepts 23:18; 31:23; conserved 13:13,22; contributes 34:ll; 94:19 costly 163:7
51:7; s4:13,16; ss:8; 74:3; 161:8; 194:13; 149:5 contributing 140~11 costs 72:23; 119:20;
60~20; 61:13 280:8,22,24 consider 12:6; 14:20; 153:12; 164:3
contributions 28~6
compartments 229:lO conceptual 164:9 16:8,19,25; 21:3; 33:24; countries 19013; 272:9;
79~24;87~14; 97~8; contributors 48:9,10
competes 63:7 conceptualization 275:12
117:19; 154:17; 164:15; control 56:lS; 64:13;
competition 179~6 227:3 country 270:16; 284:3
176:l; 197:22; 204:21; 88:5,17; 101:lO; 1OS:l;
complementary 4625; conceptualize 232:9 230:6; 235:16; 255:12; 149:17; 174:12; 218~6 couple 37:17; 41:17;
145:19; 229:s conceptually 161:3 260:4,7; 277~10 controlled 14:15; 45:15; 19:10; 56:15; 6S:7; 86:22;
complete 43:24; 59:12, concern 26:3; 38~7; considerable 183:9; 206123 ?3:11;95:10;96:8;
14; 62:11;85:13;92:10; 39:lS; 82:22; 147:21; 285~8 controls 204:19; 212:s; 113:11; 11613; 126:12;
183:l; 202:1S, 17 16S:21; 170:9; 208:21; considerably 191:20 220:20 127:3; 128:12; 130:16;
completed 160~24; 284:l 210:14; 213:4,15; 217:12; 137:22; 164:25; 173:24;
consideration 133:5; controversy 252:lS
218:7; 219~24; 220:12,14; 213:8; 232:21,23; 236:13;
completely 43:15; 229: 17 convene 240:23
242:ll; 2SS:ll; 259:s 241:17; 255:ll; 26S:ll;
171:15 considerations 78:l; convenience 44:12
concerned 38:3; 102:17; 267:l; 287:9; 295:12,13
completeness 218:23 143:23; lS4:2; 188:17; convenient 40: 15
262: 14; 285: 1 207:13; 220:17 course 10:14,20; 22:14;
completes 193:25 conventional 19:S, 18; 40:12;41:22; SS:ll;
concerns 25:4;71:12, considered 84:20;
completion 69:18 14;82:7;83:15; 191:lS; 20:9; 42:21; 87:17; 89:21; 69:18; 73:16; lOS:2;
complex 25:1,2; 66:9, 146:lO; 152:25; 175:16; 91:6,1S, 17; 104:25;
207:13; 296:16 107:l; 120:24; 128:8;
12; 124:22; lS9:3; 179:18, 202:6; 207:6; 272:9; 105:2; 108:5; 164:24;
conclude 72:24; 175:24; lS7:6; 160:11; 163:lS;
19,23; 249:s; 256:24; 275:5; 296:12 167:7; 179:3; 180:18,23; 167:6,9; 172:21; 176:17;
203:22 considering 76:2,S;
268~14; 277:l; 278:4; 256:lO 193:l; 222:s; 258:s;
286:6 concluding 77:19 222:l 277~2; 286~3
converge 14:lS
complexes 6S:21 conclusion 24:3; 61:9; considers 294:13 course-and 109:s
convert 118:21
lS1:6; 207:25 :onsistent 7~:5; 233:6;
complexity 139:23; converted 37:12 :over 94:6; 231:lS
140:7,21 Iconclusions 129:24,24 235:10; 276122; 277:3
converting 118:17 :overed 224:9; 269:14
compliance lOS:17; concordance 139:16 :onsolidation 179:21
convince 31:25; SO:3 ZPMP lS7:12
283:7 concurrently 209:21 :onsortia 46:22
convulsion 85:s :rack 72:2
compliant 276:2; 282:23 condition l43:9 :onsortium 30:20;
convulsions 85:6,10, :ranial42:6
complicated 26:ll; 30:s; conditions 283:7 f7:11; 74:9; 146:6; 228:9;
10,17 :ranium 35:l
40:1;47:18;65:19;73:17 conduct SS:14; 128:20; 229:2
zonstituency 22:18 cool 48:lS crank 93:25; 115:lS
complies-we 274:2S 159:lS; 163:14; 16618;
192:21; 201:3; 270:6; constituents 10:s cooperative 199:5,8; create 52:3; 110:17;
compliments lS1:2S; 20418 161:2S; 233:5; 285:13
153:4 271:4 Eonstitute 236:17
conducted S4:22; coordinated 124:23 created S1:17
comply 223:12 constituted 289:19
156119; 201:13; 259:lO; Coordinating 243:lS creatine 20: 10
complying 277:l constitution 289:7
270:17 copper 65:21; 66:3 creating 106:12
component 115:6; constrain 104:23
conducting 269:24 copper-60 665,9 creatinine lo:13
174:7; 21620; 244:23; construction 120:s
246:lS; 261:16,17,18 confidence 177:s; copper-64 66: 11 creative 123:4
178:13; 215:19,22; 23813, consultation 208:20;
copy 5:s; 29:6,9; 214:21; credibility 165:6
components 138:6; 209:4; 210~4; 220:6
4 218:7
141:24; 142:3; 208:18,23, consumer 6:21 credible 278:20
25; 216:12; 279:lS confident 3l:lS cored 109:23,24
contain 15:l criteria 20:s; 64:9;
composition 216~9; confirm S3:10,11,1S,lS corner 43: 12; 44:3 205:23; 214:16; 215:7; ’
confirmation lS4:15 container 220:2
218~4 coronal 82: 16; 87:9 292: 14
confirmational 14:7 contend 162:17
compound 3S:5; 52:2; Corporation 6:7 critical 9:22; 34:9; 78:2,
S6:S; 57:7;66:11;73:13; confirmatory 67:13 content 199:19 5; 168:19; 210~20; 225:5
corpus 65: 12
173:25; 174:s; 271:22 confirmed 62:lO context 112:l; 137:2,16, cross-species 162: 11;
23; 164:16; 176:4; 222~3, corralled 122:l
compounds 2619; Conflict 4:11,13,21 correction 51:14 167:19; 171:22
73:18; 95:24; 160:13; 4,13; 225:7; 278:12;
conformed 13:2S correctly S9:19 crossed 279:s
166:s; 192:lS; 205:6; 283:22
confounding 120~24 correlate S4:lS; 64:3; crossing 70:2
226:12; 233:23; 241:5; continuation 218:25
confused 194:14 69:14; 231:2; 244~7; crucial 107:12
250:17; 272~24; 273:1,4, continue 9:7; 28~11;
15; 275:2,7 confusion 71:16; 183:9 47:22; 7S:lS; 90:6; 269:s; 286~24 crystal 111:13
comprise 53:13 congratulate 79~6 I 159:lo; 250:2; 257:s correlated 52:19 CT 94:16; 121:19

Miller Reporting Company (202) 546-6666 Min-U-Script@ (7) comparable - CT


Hearing Nonclinicd Studies Subcommittee of the
December l&l999 Advisory Committee for Pharmaceutical
-
Science

&bed 126:22,23 128:21; 130:8,25,25; CBEAN 6:14,14; 73:s; d egrade l4:5 dlestroyed 82~20
cubic 95:2 131:2; 138:20; 145:13; 1 19:9;231:23;240:10; d egrading 13:24 dlestruction 57:4; 58:15,
1.47:5;151:20;157:23; 2:41:23;245:7,10;260:15; d egree 81:17; 110:22; 17;83:8
culture 12:22; 36:7; 54:7;
I.59:2,9,18; 162:14; 2:84:9;294:8 187:12; 243:19 Cletaif 9:21; 10:2; 20:2O;
166:21;167:18
1.72:19,21; 176:5; 180:20, aleath 12:9,13; 150~5 d legree-and 85:23 2!2:22;86:4,12,14;99:11;
cumbersome 4O:l; 41:5; i !l; 181:20; 185:7; 187:18; aleaths 234:25 dlegrees 54:2 105:10;106:2,9,14;
130:2,3 1,88:10; 189:lO; 190:21, 109:15,16,22,25;178:17;
Clecade 9:5; 13:6 dlelayed 101:22
cumulative 147:7 i !5;192:21;193:14,25; 2!14:4,17
Clecades 31:12 dleliberateiy 163:5
cure 181:12 1194:10;199:16;2OOA2, Cletailed 9:17; 201:19,20;
116,17;201:6,24;202:12, lecarboxylase 58~2; dleliberation 260:5
cured 138:12 2!14:2,7;216:6;217:8
i !l; 203:17; 204:3; 206:10, : i7:2
cures 179:9 dleliberations 235:17 Cletails 71:s; 107:15;
I19;207:24;209:19,21,24; Clecay 103:12; 105:16
current 5:16; 11:24; 12:5; dlelighted 24:16;71:12 1.15:16; 193:9; 245:6,6
i !10:21;215:6;216:6; Clecaying 103:6
22:7,16; 28:12; 123:7; i !17:24;219:8;220:12; dlelineate 154:24 Cletect 77:6,9,10,12;
124:6; 164:23; 185:ll; Clecide 44:11;72:19;
i !31:13;233:7;242:7,16; dleliver 110:14,14 e!4:2;245:18;259:15;
195:9; 196:14; 198:5,19; 130:8; 23622; 251:ll;
i !45:13; 257:22; 259:lS; dlelivery 32:12,14,15; 2!65:22;266:15
235:5;238:8,23;239:25; 2!53:10;262:10;292:14;
i !62:8; 265: 18,19; 270: 10; 2!94:21 3 3:8,14;36:11;37:21; cletected89:24,25;
244:3;259:1 I1!71:5,6,16,23,25;272:1;
Clecided 1l:lO; 60117
163:23 2!45:20
currently l&4,17; 22:3; i !73:11,16; 277314 dlemonstrate 26~23;
Cleciding 203:16; 227:24; cdetecting 83:7; 84:17
75:17; 120~5; 121:22; cfatabase 127:13;
2!41:21 57:3;87:13,18; 179:12, cdeterminant 78:2
144:14; 151:22; 158:8,10; I158:17;159:10,21;160:1; 13;182:2;183:21;216:1;
161:21; 162:5; 165:lo; J!02:3;230:11;231:3,3; Clecision 12:19; 53:14; cietermination 208:8,17
2 59:10;280:3
16613; 167:5; 198:8; !33:1;238:6;245:25; i ‘3:21; 126:19; 143:13; cfetermine 17:21; 59:5;
238:17; 244:lO; 247:13 1.89:14; 253:9; 273:21 dlemonstrated 26:22; ci5:15; 69:15; 7O:l;SS:l;
~52:18,19;253:1;271:21 1 13:21; 278:21
curve 33: 10; 43:20; databases 132: 15; cfecisionmaking 155:2; I156:16; 176:25; 192:15;
44:19;55:7,14;63:16; 1.80:11 dlemonstrating 95:17; I193:25;206:25;219:12;
152:6,9;157:17;233:3,5; 2i59:2 ,1!59:19;265:4;267:9;
168:9,11,12; 170:13; 156:13 cdecisions 26:14,15,16;
171:21; 173:2,10 alemonstration 85:22 i!75:18;282:18
lataset 87:3,10; 106:20; i !7:3;29:2;116:20;
customize 196:l 1.54:24;203:25;250:1; cDenise 145:20; 224:16 tjetermined 4:18
107:6; 109:13; llO:ll, 15;
cut82:16,19;86:24; 186:11,18; 187:4,5,8; i !79:10;295:15 lepartment 40:12; 71:3; tdetermined-and 219:ll
87:25;152:3;153:17 189:7,21;l97:9 clecline 174: 11 ; ~3~6 tdetermining 25:21;
cutaneous 245:14 jataset-and 186: 13 cfecrease 175: 10 Clepartments 72:12 115:14; 69:s; 78:5; 91:5;
cutting 25:20; 72: 1,7 jatasets 92:10;110:20; cfeep 35:1; 42:6 Clepend 207:9,16 120:24;145:2;270:15;
cycle 187:lO; 294:22 127:17;185:23;197:1; cdefault 279:6 Clepended 126:lO ’ 276:14
cyclosporin 37:3,3,17 201:14;202:4 Clependency 196:22; develop 8:9; 11:20;
tiefects 105:14
date 111:5; 193:l; 2464; I.97:1 12:21; 29:3; 32:22; 38:22;
cyclotrons 30:9 cdefense 10: 15,16,18; 15:2;53:14;69:25;72:19;
cytokines 167:lO 267:24 111:6,24;13:8,12;19:3,4, cdepending 62~4; 274~23
76:22;81:7;152:22;
cytometric 153:6 daunting 85:20 7 cdepends 73: lo,16 154:14;155:10;159:14;
cytotoxic 186:9 Dave 105:20;131:24; defensive 14:2 cfeploy 1761 160:22;179:22; 181:12;
255:14 defer 279:19; 28O:lS 1leprenyl42:12,15; 60:9; 191:14; 192:2; 200:4;
David 79:15,20; 9322; deferred 158~5 c;1:8; 62:15; 77:22,22 224:14; 23O:l; 264:20
D 94:12,15;102:24;104:1; define 16:5,10,24; cdepressant 242~24 developed 19:15; 36:l;
108:2,3,15;110:22; 23:17; 55:11,16;74:10; cdepth 221:lS 46:22;55:20;61:16;
D.V.M 177:20 112:16,23;113:3;117:7; 76:14;94:14,20;123:3; 72:16;99:25;150:22;
127:1;226:14;227:1,24; tjerive 181:l
D2 54:24,24;57:16,25; 127:8,9;236:14;247:20; 152:17;156:19;183:25;
242:14;246:21;261:15; tderived 168:4; 242~7
62:21;63:1,8,21;64:1 251:2;253:24;254:5,5,8; 259:12
263:11,24;289:11 Idescribe 156:2
daily 257:23 285:5 developing 17:25; 18:15;
damage 9:4; lO:l, 8,15,
I day 14:21,24; 40:13,14, define-and 276:13
tdescribing 284:lS 31:13; 35:4; 70:4; 72:7;
22;43:6,9,13;44:7,10, 1description 27:14; 73:9;90:3;147:22;
19;11:20,22;12:15; 10,12;75:24;76:4;77:20; defined l&20; 62:25;
213:9;214:1,13;215:25; 158:10;178:14;236:3;
13:16; 14:8,17;15:1O,12; 95:20,21;98:6;152:7; 75:2;138:25;156:21;
217:3,14,19;259:17 244:lS
17:20;19:2;20:11,19; 222:5,11 244:9;254:24;272:13
56:24;85:15;174:21; Idesign 44:19,22; 4616; Development 6: 15; 7:9,
day-to 14:20 defining 25:21; 29:15;
228:8,12,22;229:5; j6:9;118:4;154:12; 20,21;8:24;9:8;19:12;
55:7;94:23;106:9,16;
236:19;249:16,21 day-to-day 7: 11 190:8,22;191:13,21; 22:13,25;23:5,12;26:11;
153:16; 168:6; 223:13;
days 9:25; 186:16,17; 196:23,24;204:3;274:5; 29:19;30:3,14;31:9, 14,
damage-specific 228:2 240:25;250:22;251:9,14,
202:7;208:7,10 277~9 17;32:10;33:4;34:10,12;
damaged 14:3,5,7 15
de 241:22 /designing 199:3; 27O:ll 40:5;41:6,15;45:9;46:24,
dare 80:25 definite 158:lO
designs 185:14; 194:21; 25;47:13;49:5,9,24;
de-stress 163:24 definition 21:lS; 97:7;
dark 36:17 195:10,10,13,22,24; 50:5,6;53:2,9;58:23;
dead 99:24; 115:2 164:li; 166:4,22; 192:9; 62:24;64:5;67:10,22;
darkening 87:24; 88:9 197:15;198:2,12,18;
deal 28:19; 53:17; 54:15; 272~7 200:15;226:11;277:5,11 70:5,22;71:20;72:16,18;
darker 42~24
67:25;68:5,10;107:1; definitions 16:7; 161:s 75:12;77:2;79:25;81:13;
data 26:18,21; 64~20; desirable 164:23; 173:22
109:15; 110:21; 118:20; definitive 159:15; 161:25 1 90:4,7,9;91:20;92:1;
67:23,24;69:4;80:16; 120:22;130:4;132:6; desire 8625
DeGeorge 157:ll; 101:9;111:19;120:16,16;
81:9;82:12;86:8,22; 176:14;256:12;258:23, desired 39:21; 67:16;
182:17;184:17,19,20; 142:18;151:6;154:24;
89:16;90:21,22;91:17; 24;286:8;292:2 138:11,17
227:5;237:7;243:17,21; 156:23; 161:12; 162:25;
1lO:ls; 116:19; 118:ll; desktop 110:15,15
dealing 47:25; 256:16 245:13;270:21;273:3; 163:4,6,7; 170:21; 175:1,
122:24,25; 123:3; 125:10,
deals 243: 16 274:2,17;276:20;277:4; despite 69:4; 74:23,24; 18; 176:6,9,17; 178:10, -- _^
15,19,22,22,23,24,25;
dealt 233:13 280:9 27214 / 11,19,24; 179:ll; 180:20:
126:8,14;127:15,22,24;

cubed - Development (8) mn-U-scripta Miller Reporting Company (202) ~46-6666


Nodinicd Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science
-
December 14,1999
-
181:5; 182:s; 184:22; 174:25 211:20; 216:25; 218~12; 190:1; 199:17,24; 200:7; 55:15; 62:20; 187:lO;
185:19; 187:13; 188:7; differentiation 175:16 221:lS; 222:5,17,22; 271:12; 277:16; 279:22; 188:1,2,5; 253:24; 277:7
190:4,23; 192:17; 194:2, differently 75:4 262:2; 272:ll; 296:ll 280:11,13; 287:12; dosing 77:lO; 174:16
11; 195:25; 196:2,19; discussing 920; 2323; 290~21 dossier 129:17
difficult 17:21; 30~7;
202:11,12,21; 203:20; 124:24; 130111; 145:s; 28:21; 96:i8; 123:5; documentation 282~24 dossiers 130:s
230:17; 244:17; 256~6; 158~24; 191:18; 198:22, 222:2,24; 239:16 documents 195:15,15;
258~17; 259:23; 269:13, dotted 279:7
24; 227:12; 251:5; 265~22; discussion 7:4; 21:s; 199:15
23; 270:12; 271:17; 275:9, double 8018
272:5,15; 286~6 24: 10,ll; 32:7; 47:8,9, dog 98:15; 99:l; 151:ll;
19; 281:13; 285:16; 14,21,22; 111:7; 130:17; doubled 43:13
difficutties 52:3; 140:13 169:14; 172:3; 237:14,20
28623; 290:3; 292:18,21, 134:21,23; 159:ll; DOULL 4:3; 5:24; 6:9,9,
24; 293:l difficulty 25:5; 119:20; dogs 287120
140:s; 256:4 166110; 175:25; 176~14; 22; 24~5; 27:lo; 47:15;
developments 8: 15; 177:5; 189:16; 193:25; dollar 112:~ 73:2; 75:22; 77:15; 78:14,
diffusion 102:10,15; 194:7; 196:4; 217:20; dollars 35:3; 39:5; 20; 79:9; 92:lS; 93:7;
112:2
104:13,17,20 220~24; 221:2,4,13,16; 112:11,12; 114:2; 124~19
develops 138:7 111:2,8; 118:13; 119:23;
digital 84:12; 90:25 223:14; 247~11; 267~5; domain 31:6; 39:2; 45:s 121:13; 124:12; 128:7;
devices 268~21
dilution 262:15 270:25; 280:21; 285:19; dominated 66:9,13 130:13; 131:22; 134:20;
diabetes 171:5 dimension H&122,24; 289:17,24; 290:2; 293:lO done 20~15; 32:8; 35:14; 136:3,11,17; 155:22;
diabetic 171:5 107:9 discussions 5:4,8; 177313; 184:16; 204:ll;
38: 12,24; 44~8; 46:4,5;
diagnosis 81:12; 125:4; dimensional 80:17; 84:s; 11:lo; 24:4;46:21; 49:17; 52:5; 68:lO; 75:3,4; 220~22; 221:3; 223:s;
262:lS 10620 146:14; 185:5; 194:14; 89:2;91:1,11;92:12; 224:16; 225:ll; 227:5,19;
diagnostic 69:3,9; dimensions 106:20,24; 19612; 272:5 93:18,20,21; 95:10,11, 229:14; 231:14; 234:25;
71:19;80:7;263:14 264: 18 disease 25:21; 53:19; 16,25; 97:6; 102:23; 237:6; 239:2; 241:19;
diagnostics 71:17 direct 27:23; 156:24; 58:20,23,24; 59:17,22; 109:14,14; 111:4,17; 242:lS; 245:4,9; 246:lO;
diagram 214:3; 217:4 224: 14; 264:17 60:1,11,13,15,22; 61:9; 114:16; l&4,16,22; 248~10; 250:20; 253:17;
75~2; 77:12; 120:21,24; 117:13; 120:9,23; 122:17; 255:5; 258:5,22; 262:17;
diagrammatic 217:4 directed 40:s; 89:19
132:18,20,21,22,25; 133:20; 134:16; 147:12; 264:25; 266:24; 269:10,
dialogue 158:17; 177:7 direction 81:6; 82:17; 133:2,5; 138:10,13; 14&S; 152:5; 155:ll; 19,22; 271:19; 274:6;
diameter 98:19 116:24; 161:9; 294:24 179:18; 181:12; 186:20; 158:25; 173:25; 193:ll; 276:20; 279:ll; 285:22;
dice lO9:3 directions 90:5; 231:21; 251:4; 263:13,13 194:16; 203:5; 20613; 287:17; 291:5; 293:22;
dichotomy 121:16 241:l disease-process- 225:7; 240119; 248~19; 295:2; 296:15
DICOM 12613 directly 33:13; 35:9; 61:6; focused 264:20 259:lS; 264:l; 27O:lS; down 5:23; 15:3,15;
93:13; 227:21; 269~8 diseases 24:25; 25:2; 278:22,23; 281:lO; 41:5;44:12;49:25;72:11;
died 5622 285:21,25; 2861; 290:5;
Director 6:4,15; 92:20; 72:2; 76:12; 150:23; 75:5; 95:3,9; 97:l; 98:24;
diffentially 108~21 98:3; 116:23; 121:16 179:9,10,13,23; 18O:S 294:23; 295:16 103:14,16; 105:14;
difference 8:23; 32:l; dirty 81:17 dish 54:5 done-because 28O:lS 109:22; 111:13; 115:18;
45:1;60:14;87:15;96:13; done-not 280~17 120:23; 125:l; 128:17;
disadvantages 69:22; dispense 15913
97:9; 152:22; 169:6,9; 130:16; 138:7; 140:21;
258:7 dispersed 110123 door 98:23;99:1; 11614,
225:23 145:4; 196:15; 211:21;
disagreement 155:16 displace 62:13; 165:s 14
differences 38:13; 215:16; 225:17; 226:14;
disappear 104:5,5 dopamine 55:21; 5613; 242:19; 249:15; 250:2;
74:16,17; 131:21; 137:25; displaced 63:20
disappeared 60:20 57:1,8; 58:2,5; 63:4,6,7, 251:16,17; 252:9; 257:21;
154:25; 165:13,18,24; displacement 62:7,12 19,20; 67:2 260:12; 291:9; 294:17;
171:2; 210:25; 211:1,22, disappearing 206:16 disposal 165:7
25; 274~23 dopaminergic 57:lS; 295:6
disappears 40:24 disposition 201:7 58:6; 174: 1
different 14:3; 15:23; disappointed 40:19 down-regulated 15:7
disseminated l99:7 dosage 207:9,10; 217:13
16:16; 17:21; 20:18,19; downgrading 265:5
discipline 30:13 dissemination l22:2 dose 36: 14; 37: 16,lS;
30:7; 37:ll; 45:16; 55:15; downloaded 127:12
61:23; 65:7,20; 66:2,24; disciplines 70:17,18; Distance 70:24; 102:14 39:20,20,22; 40:10,23;
291:12 41:4;42:16;43:5,9,11, downregulated 247:2
67:l; 69:s; 76:2; 78:lO; distant 103:4; 161:22
79:ll; 80:22; 81:1;85:18; disclosure 177:14 12,12,20; 44:18,20; downstream 63:11,22;
distinct 9l:l; 128:15 69:14
88:4,15; 89:1,6,10; discomfort 163:9 45:20,21; 53:5; 54:12;
distinction 32:5; 98:3; doxorubicin 147:8,15,
90: 18,22; 94:6,15; 96:7; disconnect l74:17 55: 12,16; 62:4,5; 85:9;
206:15; 225:20; 226:6; 16,21
125:9,20; 130:4; 132:l; 147:7; 148:20; 150:6,7;
discordance 155:8,12, 245:14; 277:12
134:13; 144:ll; 149:24; 151:2; 154:7; 162:5,10; doxorubicin-treatment
17 distinctions 237:17
157:2,21; 160:12; 164:10, 168:1,9,11,12,15; 20: 17
11; 166:21; 171:l; 187:19; discovering 151:24; distinguish 94:s; 108:17; 169:10,21; 170:13,17;
152:lO dozen 112:s
189:6; 190:14; 192:s; 237:19 171:1,18,21; 172:2,12,
discovery 29:19; 35:3; DR 4:3; 5:24; 6:3,6,9,12,
193:15; 194:13; 198:13, distributing 128:2 15; 173:1,7, lo; 174:ll;
94:8,9; 96:5; 160:13; 14,18,22,23,25; 7:3;
18; 206:21; 207:10,13,13; distribution 29:24; 182:15,16,16,20,20;
161:11; 162:25; 176:5; 24:5,6,12,13,20; 27:10,
220:5,5; 223: 18; 224: 19; 42:20; 83:21; 201:24 183:14,14; 185:12,22,23;
177:6; 178:9,19; 181:16, 15,19,22; 28:16; 47:15,
225:15,22,25; 228:3; diverge 283:15 186:14,15,17,18,24,25;
17,22; 254:14,16; 293:l 15,20,21,23;48:2,6;
229:12; 231:4; 233:l; 187:2,5,7,15,16,21,22;
diversity 157:20 50:7; 51:l; 73:2,2,3,7,8,
236:13,13,20; 241:l; discrete l70:4 188:16; 190:9; 192:8,21;
divided 224:18 10,23; 74:7; 75:21,22,22,
242~2; 251:13; 258:20; discuss 13:3; 21:7; 194:19; 225:12,16;
23; 76:ll; 77:15,15; 78:6,
262:lS; 272~24; 273:l; 23:10;49:14; 128:12; Division 79:16; 147:5; 259125; 271~20; 272~24,
14,16,20,21,23; 79:2,9,
274: 18,19; 275:6,23; 137:l; 182:13;211:10,15, 150:9; 193:2,3 25; 273:23; 276:5,5;
14,18,21; 8O:l; 81:14,14;
18;222:11;223:1;285:15; divisions 143:ll; 279:23 277:5; 278:6,22
82:l; 84:9,25; 9O:lO;
differential 152:2; 290: 5 DNA 14:12; 15:10,12,18; dose-dependent 147:9 92:18,18,19,24; 93:4,7,
S&15,16 discussants 130:24 137:6; 141:lS; 166:17; dose-response 225:lS 8,17,22;111:2,8,8,17;
differentiate 95:19 discussed 4123; 22:lO; 249:4,16; 250:22 doses 38:s; 40:5,11; 113:1,7; 114:7,10; 115:4,
differentiating 95:6; 23:13,15; 137:16; 154:19; document 2621; 125:14; 43:21;44:13; 52:lO; - 12; 117:3,6,18,22,24;

Miller Reporting Company (202) 546-6666 Min-U-Script@ (9:I developments - DR


Hearing Nonclinical Studies Subcommittee of the
December l&l999 Advisory Committee for Pharmaceutical Science

118:2,13,14,14,14,14, !4;63:11;67:22;70:1,22; cdynamic 77:23; 148:19; 2!49:6;250:1;258:3; 144:25;201:21


is; 119:9,23,25; 12O:l; ‘2:18;75:11; 77:ll; 1.72:5;224:20 2!62:15 eJevation 170:1,10;
121:11,13,14;122:19; ~9:25;81:12;91:10;92:1; cdynamics 32:6; 34:4; Hective 22:25; 33:23; 2!77:22
123:5,10; 124:12; 125:s; p4:7,9;96:4,5; 13O:l; 4L7:17 i6:2;118:9;141:2,3,3; eelicited 159:25;171:19
.: 126~6; 128:7,10,11; 131:5;138:4,16,23; .63:23;176:16;178:14; e!Ise 41:3;214:25; 216:15,
_,.,*.-: 139:1,4,11; 142:23; !79:10
130:13,14,15; 131:6,22;
132:14; 133:8,8,23; 143:ll; 145:3; 149:18; E f rffectively 6322; 68~11;
1.8;258:18;292:16
f risewhere 43:2
134:8,20,23; 136:3,11, 150:4,20,22;151:6; 1~60:23
154:22,23; 161:ll; f elucidated 142:12
14,17,17;155:22,22,23; I: 29:8;83:5 f effectiveness 206:8,25
156:1,1; 157:10,11,25; 165:12,24;169:7;170:25; f tlucidation 213:13;
fwgerness 160~6 f dfects 36:9;76: 12;
161:7; 166~3; 168:22; 171:25;174:9;175:1,17; i !47:8
177:6;178:9,10,11,19;
fFarlier 59:9; 63:5; 81:14; '7:23;84:17;125:5;
174:2; 176:24; 177:13,16, 140:8;165:20;169:6; f embarking 164:l
21; 180~12; 182:17,21; 179:l; 182:23; 183:s; !~0:10;107:16,17;130:21
1136:17;142:1;144:12; 1.70:1,24;173:3;175:22; f embryo 97:5
184:16,16,17,20; 204:lL 184:22;185:19;186:2; I179:13;225:13,19,25;
187:23;191:2,14,18,22;
I150:12;153:3;164:25; f nnerge 165:lS
13,15;220:22,22;221:3, 1174:23;184:1;185:1; i !32:8;235:25;244:24; f emerging 178:6; 270:6
7,12,14;223:8;224:4,6, 192:3;194:2;195:25; , i !57:19;258:12,12;
1ZO4:1;216:25;248:25; Efmission 27:17; 28:3,
8,16,16; 225:2,11,11; 196:1;199:20;200:4,6, I i !66:14,19;267:16
1!79:20;283:5;290:2 i !0,25;30:24;31:2,21;
226:4;227:2,5,5,17,19, to; 201:6;203:20;204:24; f efficacious 62:20;
20,21;229:14;230:9; 205:17,21;206:6,7; eearlier-there 146:4 3)4:8; 35:15,18; 36~6; 46:s;
160115,23; 168~17
231:14,23;232:11,21; ~10:21;211:6,6;212:16; t Zarfy 11:lO; 21:s; 40:4; 4i&3; 49:20;66:7
LL5:20;66:8,15;67:21; f efficacy 25:21; 268;
233:19;234:25;236:11; 213:5;214:9,18,22,24; f rmit 54: 1
237:6,7;239:2;240:10; 216:3,5,11,12,20,21, 77:10;88:23,24;102:17; !7:11; 43:23; 60:3,5;
;7:15;69:15,16;76:14; f emitters 51:15; 53:24
241:19,23;242:6,18; 23,25;217:2,15,16,16, 1139:20,25,25;140:3,5,
~:13,15;119:3;125:6; f emphasis 29:14; 207:22
243:12,21;245:4,7,9, lo, 11; 218:9; 220:16; 244:18; I13,21;142:12,20;145:23;
13,21;246:10,11;248:10, 256:5;265:8;266:22; 129:24;137:23;138:8,15; f emphasis-and 14:23
1146:1,10,15;150:14,18;
22; 250:20; 25i:20; 252:6, 269:13;271:17;276:2; 146:19;150:6; 162:lS; f emphasize 52:23; 53:7,
1155:5;158:1,16;174:15;
11; 253:17; 254:7; 255:5; 280:4,4;281:13;286:5; 165:9,19;168:7;169:23; i !l; 7O:ll; 78:7; 106:lS;
1176:5;177:6,22,24;
257:7;258:5,5,9,22; 292:18,20,24 179:12;254:11;259:22;
1178:2;182:6,19,25; 1!27:18
259:5,24;260:15;261:14; !73:23
drug’s 139:17 1183:5,18; 184:11,14; f emphasized 74:2
262:4,17;263:10;264:10, f efficiencies 274:12,15
drug-development 1185:12; 188~4; 193:7; f Emphasizes 78~11
25;265:10;266:24; 206:14 194: 10; 202: 11,20; f efficiency 180:25;
268:17;269:10,17,19,20, !74:14 f emphasizing 161:15
drug-free 44:2 103:11,15; 204:21;
22;270:21;271:19;272:2; 206:13,18; 211:lS; :ff icient 30: 17; 36:24; f emphysema 105:4
273:3;274:1,2,6,8, 17; Drug-induced 145:5,11; 223~21; 224~18; 230:16; ;4:21;177:16,18;183:5; f empirical 163:14
275:13;276:20,20;277:4, 147:4;150:3;242:11 !69:20;278:23;279:9
239:7;249:8,9;250: 1; f tmulate 182:ll
18;279:11,15;280:9,16; drug-synthesis 191:lS 261:5; 26617; 269:23,24; ?fficientfy 118:l; 182:lS f :nable 49:9; 50:22;
281:l; 282~7; 283:4,14; Drugs6:5;24:25;25:22, 270:7,12;279:25;282:10, dflux 32:25;33:11; 1160:22;162:19;163:17;
284:9;285:3,22;286:14, 25;27:3;32:20,24;33:8; 25;285:9,16;286:23;
20;287:17;288:2,14; 36:19;37:4,20 1165:3
34:24;36:3;39:11;49:24; 287:1,8;289:8
290:19,24;291:5,18; 52:16;67:23;71:20; dfort 131:17; 133:12; 4?nabk?d 99:20
easier 49: 18; 99:4; 279:2 148~11; 153:16; 158~7;
293:22;294:8;295:2,7, 138:15,20;142:22; t enables 108:17
easiest 40:15 187:22;192:2;199:8;
20;296:15 143:15;145:14,15; tsncode 102:13
147:25;178:14;179:13, easily 55:23; 76:16,24; 204:8,9;227:22;231:19;
draft 219:1;294:14 tencoding 102:17,25
22;180:8;185:2,25; 78:8;126:17;158:23; 247:11,15;251:12;
dramatic 37:18 260:24 254:16;263:7;267:14; txrcompass 231:20
186:10;187:19;194:16;
dramatically 9:4; 68:7 easy 55:13; 114:20; 276:lS 4encounter 54:l
195:17;199:21;221:21;
draw 202~5; 247:23 224:23;238:20;243:2; 151:9;154:16;167:7; efforts 28:7;131:16; 4encountered 62:17
drawback l41:5 250:2;258:17;259:22; 183:5;257:3 132:14;133:9;161:16; Iencourage 144:6;
drawing 76:16 278:17;286: 11 echo 80:25; 103:4; 181:3; 264:23;272:4;286:16 267:19; 281:13,17
drill 252:9 dubious 98:3 232:21; 24O:lO; 263:24 eight 89:4,8; 117:23; encouraged 137:16
drive 197:22; 243:25 due 49:22;82:1,7; 101:s ecstatic 127:24 261: 10 encouraging 39:19
driven 25:15;115:16; Duke 92:20; 98:4,13; edema 266:2 ,either 1O:lO; 18122; 25:4, encumber 183:4
226:lS 116:3;119:24;256:23 edge 25:20;72:1,7; 25;48:24;59:12;77:3;
end 7:lS; 16:22; 23:s;
98:lO 149:17;173:7;197:17;
driving 205:9; 245:l duplicative 147:l 24:9;27:11,12;59:23;
204:5;214:10;232:3;
drop 113:18;118:5,6 DuPont 113:20 educated 293:6 75:24,24;76:4;94:13,13;
237:25;238:5;284:6 95:8,9; 101:4; 106:11;
drops 292: 14 duration 53:6; 59:7; Education 71:3; 284:23
EKG 1OO:l 116:10;129:22;137:24;
Drug 4:19;7:20,21; 9:s; 61:12;74:21; 1Ol:ll; effect 39:23; 40:25; 44:5; elaborate 217:5 138:22;143:7;173:4,10;
22:25;23:5,12;25:4; 128:20; 201:5; 231:10,12 53:6;54:12,15,19;59:2;
elastase-induced 105:4 221:16;222:11;229:5;
26:11,14;28:2,2;29:19, durations 74:14 61:12;63:3,5,11,22;
Electric 98:11,25 254:14,16;266:9
22;30:14;31:14,17; during47:9;70:2;96:18; 64:l; 76:24; 77:7,25;
82:25;85:3;88:12;92:13; electrolytes lo:13 endeavor 28:4; 178:9
32:10,12,25;33:13,18, 102:13,16;193:1,16;
20,21; 34:3,10,15; 3611, 137:10,19;13S:12,18; electron 54:l endeavors 21:19; 262:14
196:4;207:5,7;209:15,
12;37:21;38:3;39:9,16; 25;216:22;219:11; 139:19,20,21;140:5,13, electrophoresis 228:9 ended 239: 11
40:10,20,21;41:21; 220:10;272:5;290:2 15,17,19;141:4;146:11, endocrine 167:9; 17O:l
elegant 99:25; 108:6;
44:21;45:6,9;47:17,18; 15;147:19;160:15,15; endogenous 35:s;
dust 260:12 118:19; 161:s
49:4,9;50:5,9;51:23; 161:19,22;163:19;171:4, 51:24; 52:16; 108:15;
duties 4:9; 281:25 8;172:2,5,14;173:22; element 72:13; 94:21;
52:17; 53:2,10,12,14,15; 120:1;145:16;148:7,17; 166:6
54:6,12,15,16,18;56:10, DVM 24: 19 174:17;175:3;176:10,20;
188:3;190:15;209:6; 176:12 endoplasmic 249:16
19;59:16,17,20;60:3,5, dwell 18:19; 56:15; 68:8,
18,19,20;61:12;62:13, 1 17;69:24; ltill 225:4,6,21,22; 238:24; elements 99:13; 141:15; endorsed 23:20

draft - endorsed (10) Min-TJ-Script@ Miller Reporting Company (202) 546-6666


Nonclinical Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999
-
endorsement 251:24 envision 231:ll 144:19;146:1;148:7,15; 8&14;94:24;108:6; 175:11;192:22,24,25;
endotheliall50:13,16; enzymatic 67:4 153:13;154:2,7;167:20; 114:lS; 116:7; 117:20; 193:3,6,15;194:15
174:7,21 enzyme 34:11,13,14, 176:2,18;190:13;207:21 127:5; 129:4,22; 141:20; expanding 120:12;
.j endotoxins 217:ll 16,18,21,22;39:14,15; evaluations 11:4 142:25; 144:21,21,24; 144:17; 152:7
,-cJ” endpoint 59:13,20; 42:9,11,11,14,17; 43:s; even 4:14; 14:16; 17:12; 145:5,6; 147:3; 148:5; expansion 175:2
138:3,3,20,23; 139:lO; 44:1,7,11; 45:7; 78:8; 25:25;26:4,15;28:15; 149:2,15,22; 150:20;
expect 47:3; 61:20; 80:7;
153:21; 197:4, lo; 201:20; 181:13 31:15;33:10;35:3;39:7; 151:21,22; 152:1,16;
110~1; 118:5; 123:12;
231:4; 277:23 169:2,24; 170:20; 171:24;
enzymes 34:9 65:10;69:17;75:1;78:7; 213:4; 214:lS
189:6; 191:24; 192:23;
endpoints 16:lO; 25:2, EPA 157:13; 158:lS 81:5,16;86:9;102:1; expectations 7:5
193:19; 196:4; 197:l;
21; 26:9,9,10,24; 45:16; 117:24;130:3;132:21; expected 62:3; 63:17,19;
equally 13O:ll; 167:11, 2Ol:lS; 217:13; 2269;
59:11;92:7;93:15; 141:17; 154:3; X%:21; 228:9;231:16;236:16; 138:25; 188:6; 213:15;
20
115:ll; 137:23; 138:15, 179:16; 182:16; 183:2; 237:4,12,20;239:16,21; 219:17; 283:5
17; 139:8,13; 159:s; equate 115:7 187:15; 195:13; 200:23, 243:1;249:13;251:3; expedite 283:12
195:14,18; 197:6;198:10, equation 261:6 25; 211:13; 212:5; 213:18; 254:9,15;256:7,22; expense 26~25; 263:s
13;234:11;247:20; 278:9; equipment 3O:lO; 219:6; 222: 19; 228: 18; 265:1,4,6; 268:11;2%5,
292:13 119:13,15,16; 122:5; 234:17; 257:19; 261:5; expensive 25:3; 2612;
11
ends 25:3 124:15,17,20 265:25;266:10;271:1,12; 32:21; 40:7; 72:17;
example-you 153:4 124:21; 256:25; 268:14
energetics 35: 11; 46: 11 equivalent 192:7 274:21;279:25; 281:ll;
284:24 examples 9:17; 18:19; experience 27:5; 28:3;
energies 28616 era 8~19 45:25;46:1;49:10; 52~24;
event 5:8;121:4;164:22; 3021; 31:1;70:12;
energy 51:15 Eric 201:23; 273:4; 282:7; 58:3;76:21;80:2;84:9,16; 160:25;170:20; 188:9;
287:ll 168:25;249:10,12 86:19;93:8,17;108:1,9;
engage 24:2 194:9;196:14;212:4;
engaged 177:6 Eric’s 279:21 events 168:10,11; 173:l; 115:9;116:5,7;131:11; 247:23;248:5;279:3
escalating 24:24; 234:23 188:6; 194~24 138:14;144:13,13;
engineer 97:17 experiences 30:19;
eventual 17:13; 69:16 151:lS; 155:19; 165:l;
engineer’s 257:16 escaped 140:20 188:5
eventually 17:4,10; 167:6; 173:24; 184:3,4,5;
engineering 97:19; especially 49:15; 85:23; 248:5;264:7;269:6 experiment 66:15,19;
125:13; 129:2; 179:ll; 73:lS; 10623; 172:16; 209:22
113:25; 114:l exceed150:7
182:14; 184:14; 234:5; 2061 experimental 158:23;
engineers l03:16 exceeds138:25
257~24 everybody 3O:lS; 159:15; 224:14
enhance 114:7; 125:3; 127:25; 13O:lS; 223:2; excellent 27:4; 41:4,14;
287:19 Essayan 130: l4,15 experiments 54:s
238:25;241:6;243:11; 47:4;49:17;55:24;56:7;
Enhancing 163:9; ESSAYEN 227:2,24; expert 21:10,12,25;
254:22;285:24 77:16;85:1;134:9
18O:ll; 267~16 232:21;245:21;262:4; 23:25,25; 111:lO; 222:lS;
264:10;286:14 everyone 8:18;132:10; except 215:7
enjoy 121:15 236:17,20,23; 251:16;
Iessential 141:l; 282:18, 188:25;238:16;273:13; exceptions 4:22 254:6;279:15;288:22;
enormous 12:23 295:lO excessive 271:6,7
25 289:7;290:12;291:3;
enormously 40:1 everyone’s 232:4; 241:1, exchange 176:15; 295:13,13
essentially 22:lS; 43:24;
enough 117:16; 134:17, j7:lO; 100~25; 139:9; 5 267:23 expertise 30:s; 293:2
18; 163:7; 180:4,5,6,7; 213:l; 221:19; 279:24 evidence 10: 14; 67:14; excitation 103:4 experts 21:11,24;
195:2; 210:7; 225:9; Iestablish 26:20; 90:23; 139:3; 149:23,24; 153:23;
excite 94:17,24; 103:5 119:13; 222:23; 236:24;
235:23;242:3,21;245:13; 148:14; 158:23; 159:1,20; 173:3; 209:s
excited 28:24;46:20 237:3;241:15;242:5;
248:18;273:12 173:14; 181:2; 215:6; evoked 266:9 251:13;254:18;290:15;
ensure 129:23 exciting 4~7; 268~4;
248:22;268:25;283:2 evolution 25:23; 126:s 292:16,19;293:10
287:ll
enter 202:20 erstablish-could 231:ll wolutionarily 13:ll explained 211:l; 216:15
?xcitotoxin 85:3,4,4,6
entering 186:l f established 16:ll; 17:7; wolve 13:lO; 27:l; explaining 39:6
c:io:l6;85:4;158:18; exclude 5:ll; 163:lS
enterprise 28~18; 182:s 124:ll; 139:i explanation 61:2; 74:17;
;.59:22;172:22 ?xclusion 5:12; 218~14,
enters 250:6 wolved 13:7; 126:14; 274:lO
!O
entertain 47:24; 246:s f established-to 228:20 158:6 explicating 49:13
txecuted 108:6
enthusiasm 239:7 f rstablishing 128:s; avolving 137:17; 145:25; explicit 254:10
I.32:15; 133:5; 154:s 180:14; 207:2; 233:3; ?xemptions 205:23
entire 5:l; 35:12; 108:24; exercised 275:6 exploit 123:3
131:13,15 f !stablishmenU 133:4; 286:17
exercises 155:6 exploration 157:l;
entirely 113:14; 162:21; I.58:16 sx 52:24,25;54:5;83:13; 158:15; 169:16,23
197:21; 205:l; 285:20 f rstirnate 67:4 S4:15;90:6,15 exhales 101:13
exploratory 274:21
entirety 197:9 f estimating 114:ll sxact 37:14,14,18; exhausted 186:21
jl:l4;146:6;268:15 explore 43:ll; 159:24;
entities 176:2; 178:24, f rt 97:l; 123:ll; 230115; exhibited 186:25 161:24; 169:lS; 243~4;
25; 179:5; 181:19; 259:7; i !40:21; 242:12,12; exactly 3025; 54:2; exhibits 169:24 251:7; 268:8; 269:ll
260:5 i !72:19; 274:14 229:15; 239:15; 248:14; sxist 141:7; 1601; 269:7,
262:22;286:1;290:4 explored 251:7; 255:16
entity 177:l; 180:19; EEurope 200:6; 270:18, 3 exploring 151:22;
i !4;275:12;286:9 exactly-should 284:s
212:17; 213:2; 275:4,18 existed l41:3 248:20;267:16,16
entry 177:22,24; 178:2; tiuropean 158:19; 190:3; examine 50:19;88:11; sxisting 60:6; 117:19;
240:16 exponentially l03:6
182:6,25; 183:5; 187:16; i !31:19;255:13;277:2,13 165:6; 197:lS; 252:22;
example 9:15; 12:4; exporting 13:24
193:7;200:10;269:20; Europeans 74:s 283:lS
278:13;282:11 13:20;14:6;15:5,5,10, exposed 273:13
waluate 148:17; 149:4; exists 12812
enumerated 11:3 184:9;190:1l;B91:14; 13,23,25; 19:16; 27:7; exposure 54:15; 69:23;
41:9;44:15;50:4;52:13; exogenous 166:6 137:6,13;142:9;147:18;
envelope 74:2 !32:10;241:18;242:23 expand 56:12; 76:23;
54:20;55:18;56:4,14; 148:20;161:19;166:4,5;
environment 98:7,12 ?valuated 261:2; 273:ll 57:6;58:21,22;59:1,15; 121:s; 13l:lS; 180:6; 168:16,23;169:10;
environmental 110:6; waluating 219:3 6&7;65:3,19;68:21;69:1; 248:16 170:17;172:14;173:7;
195:23; 218:16 Evaluation 4:19;91:5; 74:24;80:19;84:24;85:1; expanded 90:7; 149:lZ; 200:12;225:3,7,8,9;
-
Miller Reporting Company (202) 546-6666 Min-U-Script@ (11) endorsement - exposure
Hearing Nonclinical Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science
249:5; 250:16; 253:25 facing 7:lO; 8:6 127:ll; 129:17,23; 130:3, find 3324; 38~7; 62:4,7; fluorodeoxyglucose
6xposures 149:6; fact 13:9; 20:16; 31:1,7, 7; 146:17; 177:5; 187:Zl; 63:25; 65:24; 71:8; 72~4; 4610
:88:16; 195:23 11; 33:8; 37:23; 42:12; 188~23; 1897; 190:2; 123:14; 151:4; 174:9; focus 7:13; 9:14; 11:8,
express 48:8 48:lO; 52:6; 54:7; 55:10, 195:16; 199:5; 20011; 179:5,9; 18O:ZO;228:lO; 12,13; 16:22,22; 17:2;
19; 56:22,25; 57:22; 61:3, 2Ol:ll; 224:il, 12; 250:5; 238:lZ; 252:ll; 255:14; 18:l; 20~25; 21:4,9,11,
expressed 41:23; 51:12;
4;63:10;64:19;66:1;69:4 , 253:3; 259:19; 264:6; 261:20; 265:Zl; 268:9; 11,17,23,25; 22:lO;
141:17; 14&l; 159:4;
73:14,17,22; 74~8~23; 265~25; 270~7; 275~20; 269:4,4; 272:l; 278:10,2? 23:23; 26:2; 29:4; 33:13;
160:3
78:3;80:15; 104:19,22; 277~8; 293:ZO; 29611 finding 62:11,13; 39:16; 50:6; 55:2; 82:4;
expressing 172:18
122:13; 127:l; 142:lo; FDA’s 11614; 253:l 198:24; 242~25 93:9; 97:15,16; 130:19;
expression 36:19; 38:l; 148:2; 161:14; 174:19,23; findings 17:17; 143:6,8, 131:4; 134:22; 137:18;
140:4; 146:1,9; 152:2; FDA-it 275:l
186:5; 187~23; 18925; 16; 145:7; 149:8; 150:11, 143:23; 145:23; 146:9,18,
249: 14 FDA-CDER 243:23 19; 158:7; 173:13; 178:24;
190:4,14,16,22; 191:7; 24; 15l:lO
exquisitely 3610 192:1,9; 194:3,23; 1967; FDAMA 138~14 184:3; 185:lO; 198:3;
finds 93:3
extend 8:4; 11:23; 19:5; 202:14; 203:2,4,10,14, FDG 46: 14; 56: 1; 69:3,7, 200:9; 204:5,18,25;
fine 40:3; 295:2,7 205:24; 219:e 223:23;
115:lO; 16O:zo 16; 221:ZO; 225:12,23; 19; 74:24; 75:l; 264:13
230~5; 232:15; 235:23; fingerprint 15:lZ; 19:7 225:4; 226:9; 227~25;
extended 179: 11 fear 72:9; 139:7
237:17; 244:16; 251:25; fingerprinted 15:25 228:4,14; 230:7; 233:19;
extending l5:17 feasible 221:8; 262:9
252:l; 258~14; 261:15; finish 90:2; 17324; 234:2,15; 238: 15,24;
extension 31:3; 81:20 267:4; 268~20; 271:3,8; February 219:l 24O:lZ; 241:16,21; 242:l;
204:ll
extensive 108:lO; 273:23; 277:Zl; 285:ll; fed 8:l; 17:4 finite 94:18 243:8,23; 246:8,18,19;
201:25 287:15; 291:7; 294:4 Federal 21:13; 145:14; 247:22,25; 249~23;
fire 48:18
extent 51:10;71:21; Factor 50:2; 52:9; 78:5; 189: 17; 199: 18; 200:23; 250~19; 252:9; 253:7,12;
118:lO; 280~12 firm 4:25; 5:16; 159:l; 254:8,11,13,25; 260:7;
190~18; 203:13; 24612; 113:19; 174:7,10,13,15, 160:5
266:16 18,20 1bed 202:21 262:lO; 263:17,25;
firms 4:18; 5:9 279:15; 286:19,23; 288:5,
extract 166:17 factors 49:23; 91:12; 1‘eedback 62:23; 13624;
120:25; 181:6; 203:16; first 7:16; 23:21; 39:13; 22; 289:6; 295:23
extracted 214:lo 1185:18; 262:l
270:14 53:9; 69:2; 74~7; 75:6; focused 11:ll; 140:5;
extraordinarily 102:~ 1&ding 47:1 7614; 77:4;81:22; 90:16; 14615; 176:17; 196~1;
extraordinary 864 facts 151:20 I beI 111:s; 158:l; 281:3; ?1:8; 93:22; 94:7; 98:12;
r 221:18; 223:Zl; 228:13;
extrapolate 83:lO; iade 235:l !92: 1 100:23; 110:5; 115:13; 246~22; 26217; 266~14;
168:9; 171:19 failed 59:21; 79:3; 133:14 ; ‘eeiing 25617 116:9,10; 121:17,21; 268:lO
extrapolating 168:22,23 failure 59:12,15; 147:22; f ‘eels 238: 16; 296:6 128:14; 129:7; 146:13; focuses 8:5; 100:13;
163:5,7 f%I178: 1 185:11,21,25; 188:ZO; 131:lO
extrapolation 144:9; 189:19; 194:ll; 195:12;
162:ll; 170:17; 171:22; ‘air 31:ll; 146:8; 291:4 f ,elt 137121; 296:4 focusing 76:1,8; 140:13;
203:lO; 204:25; 219:4;
172:ll; 247~24 ‘airly 48:14,24; 49:ll; f ,enoldopam 174:l 144:15; 150:15; 241:2;
221:17,24; 230:4; 240:12,
extremely 166:l; 250:4 72:17; 123:6; 157:15; f ‘ertile 76:9 24613; 252:14
22; 243:4,7,21; 248:10,
18G:lO; 193:6; 235124; focussed 247:5; 262:12
extrinsic 80:17,19 f ‘ew 717; 27:9; 35122; 17,22; 259:4; 270~2;
236: 14; 254:4; 293:8; focusses 206:5; 207:23
eye 189:ll; 274: 18 t ;9:18; 102:6; 103:22; 171:3; 278:5; 281:24
295:23; 296:lO
I108:9; 121:8; 156:l; Fischman 51:1 focussing 198:4; 212:ll;
lairness 5: 15 I161:10; 195:2; 197:2; 227:3; 254:16; 263:13;
F ‘all lo:6 2!05:4; 221:ll; 27O:l;
Fischman’s 77:16
‘isher l05:9
266:21
‘alls 246:25 2!96: 1 Folded 13:24
Fl8 258:19 ‘it 31:17; 197:12; 235:25;
‘alse 164:l f ewer 260~~5 Folks 47:14; 97:18; 116:3;
276~24
F19 258:19,20 ‘amiliar 51:13; 69:24; f ibrosis 246:9 125:16; 181:17,21; 278:2
live 27:24; 80:6; 82:13,
FACA 295:18 162125 f ield 21:21; 28:5,25; Follow 24:4; 92: 12;
15,21;87:2; 113:24,25;
face 48~20; 254:19 hous 174:2 aiO:24; 46:12; 52:12; 103:24; 119:9; 1267;
145:15; 185:17; 260:23;
faced 8:20; 169:2; 254:17 ‘ancy 30: 10 C)8:12; 1OO:lO; 103:22; 261:lZ; 265:13; 272~24, 195:15
‘ar 38:25; 45:24; 47:2; ; .04:3,4; 115:13,15,18; 25 Followed 42:23,24; 8O:l;
faces 242:lO
160~2;164:3; 173:14,19, I.23:19; 131:lZ; 139:5; [ix 111:20 90:16
facile 16618 I.44:7; 229:19; 237:2;
!I; 211:4; 223:5; 242:Zl; ‘ixation 114:8; 117:25 Following 4:12,22; 42:23;
facilitate 23:3; 47:12; i !57:15
!49:15; 251:Zl; 267:5,8; 171:25; 175:lO; 189:13
68:6,19; 70:9; 73:25; f ifth 98:25 ‘ixed 83:ll; 87:20;
!68:16; 284:25 Follows 15621; 229:2
118:23; 119:6; 122:22; 108:ZO; 109:10,10;
128:9; 178:9,10; 184:22; ‘ashion 94:15; 1Ol:l; f igure 29:20; 30:4; 62:20; 114:24; 117:24 Food 28610
192:16; 193:7; 195:25; IO8:21; 119:4; 123:4; I.12:11; 198:24; 229:21;
‘lank 36:15,20; 37:19 Food-safety 286: 11
203:ZO; 243: 10; 253:ZO; 159:16; 171:l; 248:21 i !41:20; 243:8; 257:l;
i !62:8,21; 267:20; 291:13, ilexibility 5O:l; 255:2; Footing 160:5
255:17; 256:12; 267:3,15, ast 33:2; 40:24; 180:4,4,
I,6 283:3; 285:8 For-biomark 23025
23; 270:6; 276:ll; 278:8;
f igured 100:~~ Flexible 275:22; 287:4 For-were 273:22
279:12; 282:16; 287:17 as&track 138:15,19
facilitates 32:9 f iguring 46:15; 256:23 ilood 127: 1 Force 131:13; 205:lO;
‘aster 89:15; 107:13
f iled 193:l; 219:17 ilow 35:ll; 51:3; 75:3; 245:l
facilitating 8:8,13; 23:3; ‘atty 171:6
f iii 108:21; 219:23 30:20; 153:6; 214:2; 217~4 Forced 162:13
182:5; 231:22; 268~6; ‘ault 162:21; 232:15
282:10; 285:16; 289:20 f inal 202:15,17; 216:23; Vuid 142:4; 17118; 174:24 Forces 114:5; 133:15
avorite 173:25; 23214;
facilitation 2OO:lO; i !45:4 fluids 142:4; 224:23 Forest 124:25; 131:19,
!41:1
230:16; 278:9; 287:1,8; f inalized 207:5 fluoradopa 58:2 20; 251:15,19
-DA 5~9;6:4,24;7:1,5,
288~6 0,12,19; 8:2,15; 9:9,12, F‘inally 4011; 49: 14; luorine 29:18; 51:22 ‘orever 176:s; 179:23
facilities 71:6; 98:9; 9; 17:5; 25:16; 29:8; 31:8, 5O:G 52:14;67:17; 71:lO; luoro 58:3 brget Ill:11
180:3; 213:20; 283:8 2; 50:3; 52:15; 71:2; 72:6; 170:2; 219:19 luoro-meta-tyrosine ‘orgive 257:13
facility 133:17; 278:12 ‘6:1;77:1; 125:24; fi inancial4:17; 5:10,16 i8:8 ‘arm 8:3; 21:ll; 20623;

exposures - form (12) mm-U-Script@ MiLler Reporttig Company (202) 546-6666


Non&n&d Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December l&l999
-
207:9, lo; 217:14; 231:15; 230:22 144:19; 158:10; 185:7; r
‘ 123:4; 226124; 228:1,7; Gloria 6:18; 257:5
. 252:l 189:15; 191:8; 236111; ‘34:22; 235~23; 236:8,16, glycine 116:16
framing 119:lO ‘

formal 23:22; 93:l; Frank 20:5,12,20; 47:21, 294:9 ‘ t5; 237~24; 238:23; Glycosciences 151:25
192:9; 194:25; 203:12; 1Future 121:3; 133:19;
r
1 143124; 249~17; 25414; GMP 28:23; 213:23;
23; 48:2,4,6; 73:2,3,7,
, .I 289:7; 291:l; 293:3 144:7; 159:24; 161:16,23; 1 ?62:4; 265~23; 278:19; 276~2; 279:24; 280:14;
10;74:7;76:11;77:15;
,.. 162:7,15; 173:13; 221:23;
r
‘ Z80:7; 283~22; 290~9 282:22,23; 283:6
formalin 109:10,11; 78:6,16,21; 79:2; 81:14;
118~14; 119:25; 12O:l; 294:ll generality 277:7 go/no 154:24
113:lO !

123:lo; 128:10,11; 1Fuzzy 251:l; 2904 generalizable 292:lO goal 42:3; 43:19; 122:22;
formalin-fixed 109:12; !

113:2,8; 114:3 13616; 198:6; 228~17; !


generalized 14:7; 228:18 125:3; 149:4; 157:4
format 125:10,15,21; 231:l; 240:19; 241:25;
242:19; 243:17,22; 258:5;
G !

I
generally 31:22; 34:24;
S1:15;83:5; 128:19;
goals 156:ZO; 161:3;
224~9
152:5; 153:18; 199:Zo;
262: 11; 270: 13; 292:7; 1131:s; 132:23; 185:14;
271:4 IG.E 1268 Goebel’s 92:25
293:17; 294:15 I18615; 193:lZ; 206~13;
formation 254:6 I goes 14:24; 86~9; 112:ll;
Frank’s 47~20; 244:20 Igad 249: 14 ‘ !07:11; 208~24; 210:25;
15611; 196115; 213:17;
formats 1268 Igadolinium 8019; ; 112:23; 213:19; 226X$
Frank-maybe 228:5 r 287:24
formatter 24:13 108~20; 114:8,20,25; ‘ Z36:6; 238~22
free 104:Zo; 109:4; 171:6 gold 52:19; 148:23
formed 122:18; 261:6 117:25 ! Jenerals 235:l
Freedom 5:6 good 23: 16; 29:3,15;
formidable 24:7 Igain 112:13,14 ! generate 53:24; 87:3; 36~10;44~22; 50~4; 62~8;
freely 104:6 Igaining 177:8 I105:3; 126~22; 180~20;
forming 21:lO; 23:24 I 59:1;80:19; 83:24; 115:3;
frequency 103:l; 186:4 Igains 274:12 ‘ !33:25; 234:3,17; 277:19
forms 85:7 129:9; 140:6,6; 148:4;
frequently 25:3; 4022 Igallbladder 50:18 ! Jenerated 157:24; 163:16; 164:12; 172:17;
Formulary 21617 I159:5;209:15,21
friend 48:16,18,21; Igalloping 2562 18O:lZ; 204:15; 213:17;
formulate 288~21 95:ll
Igame 95:14 ! generation 13:15; 14:12; 237:ll; 238:15; 242:17;
formulated 141:4; friends 98~11 I149:16 244~8; 245~17; 246110;
283:21 Igames 117:6 $generic 123:13 25O:l; 254:l; 257~24;
front 106:7; 131:12,13, Igamma 53:24; 54:3
formulations 191:14; 16; 262:12,13; 276:19 !lenericaliy 156:22 259:16; 269:lO; 271:21;
275:3 Igap 3O:l; 241:4; 294:13 285:15
frontiers 72:2 !genes 14:15; 15:2,3,11;
forth 42:24; 157:13; !gaps 231:24; 240:13; 2)2:18; 157:l; 159:3; Goodman 22:6
fruihfu1113:3; 155:lO;
158:14; 162:12; 277:16 252:Zl; 253:1,4; 262:8; i160:10; 167:15,21 goodness 112:13
fortunate 24:12
forum 244:l; 253:lO
177:4; 194:l
FSE 81:l
FTNMR 257:18
/I
263:19; 264~6; 289:14;
294:15,15
garage 56:19
!genetic 137:8; 229:5
tGenome 32:16,18
GOP 276:3; 278:23
GOP-compliant 279:24
forward 17:6; 21:6,9,21; fulfilling 20:8 gas 100:22,24; lOl:l, 2, !Jenomic 18:22; 156:23; Gordon 100:21
23:23; 38:15; 47:13; 1158:2,13; 16O:Zl; 161:23; government 28:9; 47:ll
67:21; 75:8; 110:3; full 7:23; 8:4; 23:14,18; 10,24; 102:9,15; 103:8, 1165:Z; 168:3; 229:4 governmental 157:13
13O:lZ; 136:24; 137:2; 28:1;72:21; 1lO:ll; 12,20; 104:6,20,23,24;
180: 10; 197:ZO; 202:4; tGenomics 8:24; 12:20; grabbed 122:lO
151:20; 155:20; 158:22; 105:8; 116:8,9,12 A19:25; 158:13; 178:ZO;
163:ll; 208:1,9,11,17; 215:20; 251:23; 274:Zl; gather 263:16; 276:22; grade 216:17,18
289: 1 229~4;254:15,17
209:7; 210:16; 212:l; 283:25 gradient 103:21,24,25;
full-scale 251:12 3enomicslproteomics
232:23; 254:4; 272:12; gathered 125:ll; 200116 25:9 104:3,4; 115:16
273:Zl; 274~20; 279:2,14; fullness 159:21; 160:8 gathering 122:4 gradients 103:l
28O:ZO; 295:23; 296:2,3, genotoxicity 145:24;
fully 65:1;73:15; 148:6; gave 50:17; 227:5; 158:9; ZOO:15 gradually 60:25
13 19010; 251:25; 276:2,2; 239:Zl; 271:20 graduate 102:21
fostered 203: 10 279:24; 282:18,23; gentlemen 48~6
gear 99: 10 Genzing 109:4 graduates 102:24
fostering 145:21 285:23
gears 129:12; 161:6 George 92~24 granted 5:3; 187:9
found 54:14; 56:23; fully-cooked 129:17
gee 118:18; 119:5; gets 32:25; 33:19,20,22, graphics 102:25; 106:ll
60:24;63:16;88:15; fun 123:4 120:19; 121:14; 125:14;
111:19; 124:5; 151:4; function 7:22; 8:4; 13:lO; 22; 115:18; 119:4; 194:14; grateful 48:7; 128:ll
126:4; 222~7 250:6,7
161:7; 188:13 17:8; 29:13; 34:5,5; 35:s; gratitude 48:8
geek 107:17,18 GFAP 88~9
foundation 159:l 106:16; 124:24; 147:7; grave 160:3
149:16; 150:14; 248:13; gel 159:5; 228:9 given 12:21; 24:6; 37:3,
four 40:15,22; 51:2; great 43:17; 52:2; 53:17;
70:25; 100~14; 118:9,9, 283:2 gels 152:1,3 j; 63:15;77:15; 147:8; 54:14; 64:6;67:21,25;
13; 122:9; 144:13; 169:24; functional 13:9; 31:21; gender 148:22 156:6; 165:l; 208:18; 68:5,9; 77:5; 79:5; 107:l;
200:18; 202:ll; 203:4,7; 32:3; 36:25; 50:20; 102:2; gene 14:24; 15:5; 16:l; 209:3; 213:16; 232:25; 109:15; 110:20; 111:4,14;
236:18; 242:2,19; 24614; 107:1,23; 128:18; 171:14; 59:1,3,3,4,6; 88:23,24; 279~2; 281~23; 283~6 120:22; 130:6,12,13;
248~4; 255:8,25; 270~22; 264: 15,20; 286:24 140:4; 146:1,9; 147:5; gives 19:24; 44:18,19; 176:14; 210:24; 214:17;
277:6; 287: 14 functioning 1O:ll; 33:ll 249:14 54:17; 81:2; 113:22; 221:6; 239:5; 266:16;
four-week 230:16; functions 7:17; 50:21, gene-tox 239:13,13 175: 19 26717
277:17; 28O:ll 23; ZOO:12 general 7:17,21; 8:21; giving 36: 14; 52:7; 79:23; greater 66:21; 86:8;
fourth 91:2; 98:25; 10:4,6,15,16,20; 11:14; 94:2; 107:l; 136:22; 164:2,3; 165:6; 174:14;
fundamental 30:16;
235:15 111:5; 162:3 12:7; 13:lO; 18:20; 20:18; 197:21 193: 17; 249: 13
Fowler 41:18 28:18; 49:21; 67:7; 75:25; gizmo 97:14 green 15:7; 42:23; 43:7
fundamentally 114:13
fraction 15:l 76:13;94:5;98:11,25; gland 65:12 grew 48:15; 146:16
fundamentals 70:25 113:l; 125:lO; 126:2;
fractions 188:3 GLC4 35:25 grids 158:14
funded 245:24 129:5; 133:20; 134:23;
frame 107:lO; 242:5; glial88:lO grips 222:lO; 228:4;
funding 28~15 143:23; 176:ZO; 182:19;
294:8 global 33:14; 270:14; 284:6
further 3O:Z; 33:4; 63:24; 185:l; 189:20; 197:5;
framed 240:16; 241:24 200:20,25; 201:7; 20412; 272:15 gritty 251:16,17
76:23; 78~7; 84:lO;
framework 197:ll; 101:25; 102:1,16; 106:2; 211:5; 220~24; 221:4; globally 35:ll gross 142:15; 190:13
- -
Miller Reporting Company (202) 546-6666 Min-U-Sdpt@ (13) formal - gross
Hearing Nodinicd Studies subcommittee of the
December lb,1999 Advisory Committee for Pharmaceutical Science

ground 28:15; 30:25; 22419;232112; 233:21; !1:7; 80:25; 82:12; 92:19; high-tech 129:19 25; 126:13
128:9; 176:13; 248:18; 294~25 132:7; 208:10,11; 241:23; high-temperature 118:3 host 10:15,16,17; 11:6,
i60:15 !43:3; 251:6; 257:3,5; high-value 253:12 24; 19:3,4,7; 142:13
groundwork 47:6; 49:18 170:19; 286~7; 288:5,16; hot 48~20
H higher 43:21; 97:14;
?89:16; 293:22 Hotel 98:23
group 23:15; 28:5; 74~4; 105:6; 112:3,4; 115:17,
96:20,20; 97:18; 146:3, leard 27:25; 107:16; 17; 174:lO hottest 42~23
21; 192:18; 222118; H 83:5 130~24; 178~20; 181:3;
highest 222:2 hour 37:2; 118:5,7;
223:16; 228:l; 229~20; hairless 145:l; 149:lO 184:1,25; 222:6; 233:ZO;
235:13; 246:Zl; 252:16; highlighted 155:ll 13618
23O:l; 231:17; 235:19; half 469; 665; 73:19;
367; 89:2; 98:4; 121:15; 253:14; 259:16; 260~17; highly 1321; 164:23; hours 40:21;44:1; 55:5,
236:2,17,24; 238~14;
215:16 z61:ll; 263:ZO; 275:20; 25621 5; 89:4,8,13,13; 100:5;
239:16; 240:22; 241:ZO;
284:15,19; 285:4,17; Hillman 122:19 113:17; 117:23; 118:2,2,
242:5,18; 246:13,22; half-life 29:17; 33: 10;
18S:Zl; 289:9,23,24; hints 162:l 6;174:11;261:10
251:8,16; 254:6,9,11; 57:5,8; 40~20; 44:5; 52:2;
255:7,13,13; 281:14; S4:12;66:7,11;78:9 291:lO hire 180:4 house 260~11
28611; 287~7; 288122; hallway 29:7 %raring 623; 50:14; histochemicals 112:18 household 98:16
289:5,19; 290:13; 291:21; haloperidol62:21 136:5,7,8; 253:18,18; housekeeping 4:9
histologic 114:17
293:ll; 296:10,14 264:lO; 285:17 how-maybe 293:7
hammer 122:16 histological 90:12
groups 21:10,12,15,17, lreart 7617; 96:15; 100:3;
Hammersmith 54:22 histology 87:17,18; HPLC 214:18
18,25; 23:25,25; 79:3; 147:22; 249:19
hand 3620; 72~7; 76:19; 89:9,21; 104:25; 108:2,2, huge 70:6; 121:23; 152:6
158:9; 160:13; 189:11,12; hearts 107:14
77~5;94: 1; 97:3; 147:24; 4 human 15:l; 17:13,17,
236:Zl,24; 240:24,24; 155:15; 238:4; 275:20 heavily 133:15; 161:15
245:21; 252:l; 263:17; histopath 148:23; 150:5, 22,25; 18:16; 23:l; 32:16,
handle 4:lO; 151:23; Hedlund 99:14 12 18; 35:18; 41:11,11; 47:3;
264:6; 267:14; 279:16; heightened 26:3,3
195:3; 273:24 histopathologic 11:4 50~24; 53:1,4; 56:4,6,8;
289:7; 290:1,8,12,19;
handout 29:6; 50:20; held 106:3,6; 217:20; histopathology 147:11, 64:3; 67:21; 73:14,21;
291:3,7,11; 293:ll;
294:Zu; 296:12 58:17; 12O:ZO 295:21 12; 186~6; 187:6; 189:7; 77:10;83:11;86:11;
hands 99:8 helium 100:22,23; lOl:l, 19610; 2OO:Zl; 26O:Zl; 115:8; 116:11; 141:12,22;
groups-you 294:20
handy 34: 18 1, 14 266:19 143:9; 154:22; 155:l;
grow 257:9 160:25; 162:19; 163:9;
happen 16:14; 47:5; help 7:12; 9:22; 21:20,25; historic 31:8
growing 1021 26:7,13; 27:1,2; 38:22; 164:21; 166~19; 181:20;
120:19; 122:7; 142:18; historical 187:20 182:16; 183:5,14; 189:10,
growth 14~5 39:17; 40:7,9; 45~2; 48: 11;
143:17; 232:14; 249:2; historically 20: 11 22; 192:16; 202:12,20;
Guait 103:16 266:15 51:2;59:11;70:1;83:17;
guess 47:15;74:1; 93:9,9; 130:6,9; 140:17; history 23:7; 147:16; 211:8,13; 214:lO; 232:16;
happened 36:5; 43:6; 239:2; 241:13 244~6; 250:13; 257:14,25;
107:16; 125:19; 126:2; 144:2; 182:13; 189:14;
256:3 194:11; 236:9; 238:14; hit 130:18 258:4; 26617; 269:25;
13O:lO; 136:8; 203:13;
happening 9:9,17; 253:22,24; 255~20; hoe 291:20 27016; 271:ZO; 278:10,
218:23; 221:14,24; 223:4,
33:15,17; 35:2; 121:4; 263:17; 268:5; 276:4; 13; 279:25; 281:8; 282:21
15; 224:5,10; 225~8; hold 5:23; 20:7; 2418;
266:16 279:20; 288:22; 291:13 humanderived 35:23
2261; 229:1,18; 230:4,7, 77:3; 128:24,24; 143:15;
9,12; 23612; 253:14; happens 34:18; lll:l6 helped 132:2 20212; 208:6,7,13; 210:6; humanized 12:22
255:l; 257:20; 259:8; Happer 100:21 helpful 31:22; 96:5; 218:ll; 220:8,9,14; humans 38:13; 41:13;
270:3; 272: 17; 274: 15; happy 24:20; 27:8; 29:8 227114; 229:15,22; 230:3; 251:25; 286:13; 295:9 53:12,16;93:16; 115:ll;
275:10,20,22; 278:lZ; harbinger 165:16 243:5; 248~18; 255:22; holds 101:12; 155:l 149:9; 160:23; 162:18;
279:ll; 281:6; 282~20; lard 59:10; 115:6; ,68:20,24; 271:9 168:lZ; 172:18; 176:ll;
home 284:19
283:14,19; 285:14,24; 15l:ZO; 183:23; 261:4; ielping 3O:l 177:l; 185:23; 186:l;
288:5,24; 290:7,14; homeostasis 10:9,12;
!81:6; 285:5 ielps 64:13,15; 230:16; 187:16; 188:l; 189:12,14;
291:24; 296:8 12:6,8; 15:7; 19:12; 140:2
143:25; 256:12 19O:Zl; 192:8; 193:7,8;
nardware 7O:ll; 75:18; homework 38:24; 291:l
guidance 123:l; 178:7; 194:13; 205:9; 212:25;
120:2,8; 121:9 hematocrit 171:10,11 homo 42:6
194:25; 195:13,18; 213:2,16; 237:15,21,22;
199:19; 201:8; 203:25; harm 257:24 hematology 11:2 honor 176:7; 233:22 259:4; 265:18,19,22;
205:1,12,16; 208:4; harmonized 27621 hemisphere 87:8 hope 7:12,18; 9:19,21; 266:5,8,23; 275:12,16;
210:12; 212:ll; 215:5; Harvard 51:l hemispheres 86:l 21:2,3,5; 23:22; 24:3; 276:4,18; 277:7,14;
216:4; 217:20; 218:24,24; harvest 47:6 Hence 175: 19 75:24; 110:25; 159:9; 282: 12; 283:6
219:1,3; 277:6; 279:Zl; hat 129:12,13 172:20; 221:16; 262:12; hundreds 153:6
hepatotoxicity 145:11,
281:4; 284:13,13,25; 24; 158:9; 229:5; 240:20; 275:16 hurdle 72:13
hate 157:18; 294~24
287:12,16 hopeful 102:21 hurdles 180:22
have-l 196:20 255:lO
guidances 195:16; here-but 228~5 hopefully 4:7; 134:20, hydroxyphenylalanine
215:21; 259:2 hazard 161:16,18;
163:10; 164:24; 167:7; here--from 250:8 24; 184:4; 219:4; 222:lO; 66:25
guide 4l:4 224~14; 229:14; 23O:l;
176:ll; 210:4 hereby 296:21 hyperplasia 170: 11
guideline 287: 11 236:9; 238:8; 248:17;
head 37:23; 98:18; Herman’s 147:5 hyperpolarized 100:23;
guidelines 72:9; 75:7; 251:15; 255:15; 294:4
226:15 hesitant 293~24 103:11,19; 105:8; 116:8,9
126:2; 23O:Z; 276~22; hopes 39:6
headache 37:9,12; Hey 236~2; 23914 hypersensitivity 245:16;
277:21,24,25; 278:13; hoping 8:ll; 272:2
243:l; 244:ll 247:11,14
279:7,20; 280:7,24; high 8:25; 15:24; 38:l; horizontal 87:lO
284:24; 285:19,21; 287~2, headaches 243:1 48~24; 61:20; 87:5; 98:12; hypertension 175:5
headed 122: 19 99:7; 104:20; 105:23; horrendous 180:22 hypertrophy 171:14;
5,13; 288:7
health 16:lO; 28114; 79:4; 106:10; 113:20; 178:21; horses 48:16 175:1,7,17
guiding 73:24
guinea 100:7; 101:22; 210:4; 250:14 247~4; 256~7; 272~24 horseshoe 48~22 hypothesis 39:lO; 44:25;
103:20 healthy 42:9; 281:23 high-field 121:21 horseshoes 48~17 45:5
Gwyn 155:25; 198:21; hear lO:2; 14:24; 20:4; / high-level 280:8 1 Hospital 54:23; 121:17, hypothetical 151:15;

ground - hvnothetical (14) lWi+r-11~.Grrinti Milbr Rmwvdrrrr ~r\rn~~~~r f?lW\ CL& &ALL
Nonclinical Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999

282:20 S6:13;75:1;81:1@,84:11; iimperfect 41:2 i nasmuch 16O:ZO; 170:9; ilndication 26: 15; 88:7;
hypoxic 65:23; 66% 12, 35:3; 9611; 103:18,24; i mplanted 35:23 I.72:22 188:8; 191:23
16,18,21 107:6; 116:8,9,11; i mplanting 117:ll i ncidently 127:24 ilndications 142:7;
118~12; 126:16, lci; 127:2; i n&de 11:2,5; 22:4; 191:12; 192:25; 193:22;
iimplement 33:25; 226:lO 2!74:5
128:5 c;1:21;65:15;71:11;
I imagine 29:25; 307;
i mplementation
268:6
24: 15;
5N):19; 189:7,22; 190:22; iindicative 210:3; 216:3
35:6; 55:23; 76:24; 168~3; ;!11:9; 219:20; 226:10,12; iIndicator 84:20,21;
iimplemented 226:23,23 I.38:3; 237:14; 239:17
i’s 279:7 171:25 ;!48:11
iimplications 5:l; 163:25;
ilndicators 165:4; 171:7
ICH 189:24; 199:17,24; imagined 78:s i ncluded 2Ol:ZO; 212:15;
176:10,22,23
215:21; 272:5; 276:21; imaging 9:6; l&11; ;!24:25; 236:7; 238:Zl; ilndiiidual 15:3; 105:23;
277~5; 287~5 iimplies 207:ZO; 282:ll ;151:ll I 06~8; 110~18; 232:16;
22:14; 27:17; 29:4,12,15;
idea 17:2,8; 21:8,22; 30:15; 31:3,22; 32:3,3; iimply 282:8,16 i ncludes 216:Zl 2!41:7; 279~4
23:16; 35:7; 65:2; 95:6; 1019;45:l; 46125; 47:13; iimportance 52:22; i ncluding 32:ZO; 41:24; iindividuals 45:3; 132:23;
121:18; 122:lO; 130:13; 1~3; 49:4,21; 50:14,16, 78:ll; 177:25; 198:15; 188:22; 189:l
7‘9:3; 172:16; 21613;
208: 19; 216~9 22; 51:lo; 52:13,19; 244:22 IINDs 82:9; 185:lZ; 192:5;
2!29:6
idealized 167~25 53:23; 54:4; 55:20; 56:1,5; i!mportant 7:13; 13:12; 193:1,5,12,23,23;
215:ll; 50:2,5,11; 51:18; i nconsistencies 143:ll
ideas 155:7; 177: 12 j7:8,15; 60:16; 61:3; 64:6; 194:lO; 204:19; 205:5;
Lj2:14; 63:lO; 64:22,23; i nconvenient 34:25
S9:11;70:13,22;74:6; 2!12:5; 213:ZO; 218:20,25;
identical 44:3; 569; iS6:18;77:11;86:15; i ncorporate 73:12;
168:2 75:11;79:13,19,24; 80:7; 2!72: 18,19
51:15,21,22; 84i:5;92:22; I37~13;91:13; 94:23; 95:7; 1195:ll; 227:8 ilnduce 85:6,7
identification 91:21; 94:17; 100:13; 1061; 1130:22; 137:21,24; i ncorporated 51:20;
131:4; 153:lZ; 154:7; 1165:14; 166:2; 175:16,20; iInduced 14:4
115:6; 117:9; 121:l; 2!43:6; 263: 1
161:16; 204:5 L76:4; 177~23; 178124; ilnducible 13:3,9; 18:21;
122:21; 127:6; 128:15,24; i ncorporating 238:5
identified 32:16; 7625; 129:1,2,11; 133:16,21; j179:8; 189:9; 195:s; 145:6
91:3,16; 153:l; 187:7; 196:14; 203:19; 221:23; i ncrease 57:17; 80:9; iinduction 249:14
166:lZ; 193:3,18; 194:17; I 11:24;97:12; 117:7;
24617; 248:15 223:14,18; 22412; 22625; 222:16; 223:1,9; 232:13; iindustry 21:15; 22:5;
233: 14; 234:2; 236: 14; I147:9,12; 149:19; 150:7;
identified-and 237:9 246:Zl; 247~3; 255:24; I237:8,23; 24O:lZ; 244:lZ; 2!4:11,17,18; 25:15,16;
A I!71:9; 174:13,15; 175:3,
identify 61; 12:l; 19:4; 256:15; 257:5,11; 258:23; 2!6:4,7,18; 28:lO; 47:ll;
1248:7,9; 250:3; 252~24; Ei, 7,ll; 178:22
21:4,24; 24:l; 89:5,10; 259:1,12,15,20,21; St2:15; 54:12;70:13; 71:4,
260:2,3,8; 261:8; 262:5; 253:2,12; 265:lZ; 266~8; i ncreased 45:14; 63:20; 10,12; 75:17; 90:20;
91:9; 92:7; 131:lO; 152:5, I12o:lO; 171:12,13;
263:5,12; 264:10,11; 267:ll; 274:ll; 283:l; 1.17:1,2; 121:5; 122:10,
8,21,23; 153:6; 179:1; 1175:12,14,14,15; 179:5;
180:s; 233:ll; 243:7; 265:19; 267:6; 268:10,21; 292~9;293~20; 2965 15; 124:13; 125:13,22;
275:15; 286:18; 289:10, iimportantly 163:lZ; 3188:6; 194:24 1.39:6; 143:20; 144:17,25;
244:5; 266~19; 289:13;
292: 16 12,Zl; 291:8 165:23; 178:lO; 181:22; i ncreases 179:15 I.78:13; 179:21; 180~2;
immaterial 20420 182:Zl; 183:Z; 188:15; i ncreasing 121:lO; I.82:1,7,9; 199:6,19;
identify-are 237:17
immediate 49:3; 88:23, 202:5; 265:23 I138~6;179:23 2!02:10,20,23,25; 203:24;
identifying 11:25; 21:lO; 2!41:4; 249:25; 250:16;
129:9; 154:Zl; 198:7; 24; 129:13 Iimposes 102: 11 i ncredible 256:2
Iimpossible 183:4 i ncredibly 8:19; 4017; i !67:22; 270:21; 271:16;
245:17; 283:16; 286:21 immediately 18:13; 2!75:25; 284:21; 295:14
47125; 156:8; 219:13; Iimpressed 271:19 1111:4; 118:18; 262:23
identity 206:5; 214:14 iIneffective 33:3
IgG 88:7 22014 Iimpression 121:3; 279:2 i ncremental131:17
immense 268: 5 IND 183:lZ; 192:6,10,13, I’nevitable 72:3,9,15
II 50:8; 53:5; 68:11,16; Iimpressive 118: 19
A23; 193:24; 194:13,25; i nexpensive 64:17
70:2; 129:22; 200:9; imminent 164:17 Iimprint 168:3
206:15; 218:24; 219:6; immune 244:23; 245:16, 1199:17; 201:17; 204:21; i nfarct 96:3
Iimprove 22:24; 23:l;
220:ll; 274~22 205:6,20,24,25; 207:3; i nfarcts 113:13
23 26:8,9; 154:23; 155:2,20;
208:8,13; 211:5,10,15, i nfection 217:lO
Ill 40:7; 67:16,17; 68:11, immuno 255:14 162:8,16; 163:12; 181:2;
21; 212:5,15,24; 213:18;
16; 200:9; 20616; 207~6; immunohistochemistry 191:15 i nfiitration lo:18
215:1,4,7; 216:15; 218:s;
218:25; 219:6; 22O:ll 149:7 improved 7:20; 11:18; 219:9,14,17; 220:8,9,10; i nflammation 9:3
illustrated 8:22; 171:16 immunomodulatory 153:16; 163~20; 18O:ll; 271:4; 272:4,12,17; i nflammatory 150:23;
illustrates 1024 245:25 240:17 273:14; 274:9,25,25; 174:20
illustrating 180:12 immunosuppression improvement 23:13; 275:1,1; 280120 nfluence 190:25
ILSI 145:Zl; 156:3,10, 242:12 60:19,21,24; 113:22; IIND’s 183:2 nform 203~24
11; 157:4; 224:5,7,16; 128~23; 138:9,13; 151:19
immunotox 245:22 Iindeed 44:6; 157:7,25; Informat 203:2
229:2; 23O:lZ; 231:3,7, improvements 185:4; 159:4,20; 16O:lO; 162:17;
immunotoxicity 244:lZ; ,nformatics 91:24
17; 233:6; 244~4; 245:lO; 198:4 164:2,17
247: 10 Information 5:7; 8:25;
247:15; 252:17; 253:5; improving 181:5 Iindependent 125:19;
immutable 29:16 3:ll; 17:24; 18:5; 22:25;
254:15; 292:6,11; 293:ll; impure 208:20,22 134:9; 172:Zl; 188:9
impact 4124; 9:s; 34:4; 29~22; 32:9; 44:18,19;
294:13,13,23; 29612 impurities 209:25; 21O:Z; Iindependently 30:18 /j3:5; 89:5; 91:12,13; 96:3;
36:12; 38:9,10; 39:7,11;
image 44~2; 55:22; 668, 44: 17; 80:4,12; 92: 1; 220:6 Iindex 168:14 107:2; 110:23; 122:5,12;
8,15,16;74:13,22;75:2; 110:6; 181:13; 206:8; impurity 215:13,15,17; 128:9; 130:5; 133:22;
80:15; 84:12; 86:17,24; indicate 88:lO; 170:18;
216:8; 219:12; 244:15; 220:s 171:20 152:19; 155:18,20;
94:22; 100~18; 103:2,3; 250:13 157:17; 159:23; 187:14;
in-depth 212:7 indicated 36:7; 73:3;
105:9; 106:4,5,13; 109:7; 189:4; 197:23; 200:16;
117:14; 126:14; 128:1,3, impacting 29:23; 42~5 in-plane 107:lO 149:11; 166113; 167:25;
201:1,7,15,22; 202:1,15,
22; 129:l; 261:lZ impacts 45:6 inability 143:12; 245:12 204:17; 234:6; 281:17
16; 204:23; 205:2,7;
imaged 34:7; 57:l; 59:4; impasse 150:9 inaccessible 50:24 indicated-talk 281:17 206:4,21; 207:2,11,11,
65:13; 106:3 impasses 155: 1 inactivator 42: 14 indicates 36:17; 103:21 16,18,20; 209:2,15;
imagers 3O:ll; 262:8 impediment 201:13 inactive 208:25; 212:22, indicating 138:23; 210:7; 211:4,7,9,10,19;
images 42~8; 51:17; 55:4; impending 164:17 25; 213:6; 216:13 159:13; 167:15 1 212:6,14,18; 213:5,13;
- -

Miller Reporting Company (202) 546-6666 fin-U-scrJpt@ (15) hypoxic - Information


Hearing Nonclinical Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science

214:8;217:8;218:4; 10 2:44:15;247:10;268:18, ir ltrinsically 80~6; 84:7, 8:2:18;83:10,12;84:4;


2:5;269:2;290:23 11 8'j:16;87:2;91:24; 113:l;
219:s,9,10,12,25; nsidiously 147:14
if ltroduce 623; 177:21; 1 15:14; 133:l; 137:14;
227:10;231:24;233:25; nspect213:19;283:8 ilnteresting 35:21; 80:5;
2 08:13 1245:10; 148:25;150:3;
234:3;236:4;240:5; nspection 213:24 102:5,7;126:21;260:18;
l( 61:10;166:15; 188:18;
242:3;248:15;263:16; 2!68:3 irrtroduced 92:15; 124:5,
267:24;268:13,16,23; nstall 121:18 1:69:24;194:9;196:18;
IInterestingly 189:24 18;204:24;205:20; 97:3;198:14,15;199:25;
274:19;281:4,5,8,16,19> nstance 87124 209:25;220:6
il nterests 4:17 ; 36:15;245:10,22;
21;282:3,4;283:25; nstances 265:ll; if rtroducing 92:14;
285:23;292:12 !68:22;269:12 ilntetface 240: 18 2,55:24,24;258:22;
2 13:l; 217:lO; 273:l 2,59:24;261:9;269:21;
informative 236:7,8 nstead 56:20; 60~13; ilntetfaces 127:lO
Ifrtroduction 7:l; 79:23; 2160:14,15;283:7;284:1,
informed 277:12 ;3:25;67:14;76>:4;128:6; ilntermediate 67:12; 68:4
123:6;124:7,8;163:21; 71,18,23;285:23;286:3;
infrastructure 7O:lO; .96:7; 258:19 ilntermyelonic 2662 177:19;204:21;205:16; 2:67:l(i;290:2
126:3 nstitute 114:5; 133:15; ilnternal57:12; 125:16; 206:19;272:16 isisued 205:13
ingredient 208:24; .58:19 2!42:16; 290~3; 29611 if ltuitiie 25:19 isisues 4:23;7:9,13,14,
211:6; 212:25;213:2,6 nstitutes 28: 13; 79:4 ilnternational 15616; 2 5;8:6,10;9:18,20;16:7,
il wndated 118~11
ingredients 212:22; nstitution 22:18; 71:2; 1.95:15,15;199:24;200:1, 1;8;17:15;26:18;28:20,
hivested 39:4
214:24 157:4 7r 3; 29:11;35:16;49:14;
il westigate 56~10; 225:6;
inhale 116:12 nstitutions 74:13; iInternet 132:lO 244:21 2 8:8,18;71:10;76:21;
inhales. 101:12 157:13 iInterpret 157:23; 284:13 8 2:11;83:18;120:9;
il westigating 185:6 137:22;145:7;159:17;
inherent 51:9 nstrumental146~20 iInterpretation 30:12;
nstrumentation 25:lO; il nvestigation 185:7; 1’60:4;184:18;185:13;
inhibit 34:lO; 37:3; 38:2; 1.33:1; 159:l; 170:15; 199:20;263:3
SO:7 195:9;198:9;202:25;
39:15 1.72:15; 176:23; 207:19; ilnvestigational 201:19; 2 03:14;204:14,19,19;
inhibited 34:13,14; 43% nstruments 52:20,60:6; i !83:17; 284:17; 285:l 2:05:21; 218:lO 2 21:15;222:15;233:12,
inhibition 43:24 il:S i nterpretations 1765 ilnvestigations 158~11 15;236:18;237:9;242:10;
nsulin 170:22; 171:7,7 i nterpreting 227:lO; 243:20;251:2;260:8;
inhibitor 39:14;42:5; ilnvestigator 213:24
44:1,6;61:4,16;62:11, nsult 157:2; 158~3; i !84:24;285:19 270:10;279:18;280:5;
190:17 ilnvestigators 36:5; 283:16;284:2,5;285:22;
12;150:24 i nterspecies 154:25; 147:20
initial 11%; 23:23; 58:14; nsure 231:18 2!47:23 286:6,7,12,15;288:19
ilnvesting 112:12; 133:15 i!;sues-that 195:6
92:3;103:4;109:13; ntegrated 33:14; 202:3 i nterval40:11,23;41:5;
146%,14,19;148:11; ilnvestments 278: 11 ii :-there 151:4
ntegration 97:16; 4k4:9;45:21;169:9;
156:14;159:18; 186:4; 170:15,18; 259:14 ilnvite 248%
I170:13;173:15,16,16; il tem39:18;70:8
187:7,25; 191:12; 199:12; integrity 10:7;12:6,7; ;!34:19 ilnvohfe 5:8 ilterns 296:4,20
201:12;215:14;262:6; 14:12; 19:11,19,22; i ntervals 44:21 ilnvoived 22:4,14;54:23;
263:23;270:16;275:12 I’V 138:21;191:6,23
32:21;86:14; 132:7; i ntervention 37:ll 1.2M%;144:14;157:9; -
initially 11:12; 12:19; 142:2;144:22;145:6 1!13:20; 242:9;269:1;
58:9;131:10;156:20; i nto7:11;9:11; 10:6,18, i !74:13,15
intellect 70: 15; 75:lS; ,?5;11:9;14:2,20;15:17; J
159:10; 186:23;226:12; i nvolvement 5:12,16; -
121:6 116:4,9;17:1,5,9;19:19;
237:25;251:8 intellectual 120:3; 2!41:3
22:11;27:14;30:2;31:17; Jlack 6:6,14; 24:16,19;
initiate 23:16 176:14;233:12,16 32:2;37:12;38:3,14;40:2; i nvolves 35:18 2!7:10; 73:7; 78:22; 119%
initiated 159:lS; 246:2; intelligence 9:6 jO:S,15;51:20; 53:4; iodine 51:22 125:7;177:15,20;192:10;
284:l intend 177:2§ 52:23;66:10,12;67:21; i psolateral58:11,14 2!41:19;252:20;262:19;
initiating 262:2 73:14,21;79:13;80:25; i rrelevant 143:9; 154:25; 2!67:8;270:8;280:10;
intended 43:25; 59:3,16;
initiative 138:14; 145:22, 51:5;84:9;97:2;98:7,23; 1155:15
i !84:19
60: 11; 138:4; 209:9;
25;146:13,18;230:13,13; 101:24;106:10; 112:21; clack’s 268:9
217:17 i rreversibility 154: 11
233:6;286:23 114:20; 118:21; 119:3,3; \lames 7:2
intending 7:3; Ml:23 121:15,24; 122:4; 124:s; iirreversible 42:13; 61:4;
initiatives 145:19; intense 176: 18 77:1,13,25;78:3,7; .January 99:2; 156:12
146:24;202:24;233:7,17; 148:ll; 149:11,22;
intent 79:7; 201:17; 293:6 153:17;154:6,11,15; 140:16,22 IJapan 200:6
246:14;292:5
intention 38:2 163:22; 177:22,24; Iirreversibly 42:lS Jay 22~6
inject 52:6; 289:2 180:19;181:8,18;182:6,
interact 12624 Iis-do 224:6 iieopardy 161:9
injectable 207:12 25; 183:5;186:1;187:16;
interaction 51:4; 72:15; Iis-1209:16; 275:14 ,Jerry 27:18; 53%; 60:10;
injected 36:5; 62:3,5 188:12;193:7;197:12; 286:21;287:9
120:25 Iis-Kimberly 296:lS
injecting 42:16; 207:14 202:20,21;203:8;204:22, 1Jim 6:2,3; 24~5; 25~22;
interactions 28:3; 160:9 25;205:20;206:11,19,22 ischemic 66:20
injection 37:2,4,15; ; 27:l; 142:1,12; 14620;
interactive 11O:lS 207:14;208:14;210:13; Island 41:20
43:4;52:11;58:12,14; 153:3;227:19;229:17;
66:8 interactivity 127:4 213:2;214:4,16;219:8; isolate 1lo:18 239:21;247:1;269:16;
lnterest4:11,13, l&21; 224:13,18; 227%; 232:5, isotonic 114:21 284:lo; 285:3;288:13;
injections 52:7
5:10,15; 31:9; 33:14; 18,19;247:21;250:6,7; isotope 52:5; 66:5 291:5;293:22;294:2;
injury 105:4; 150:12,15; 256:18;257:1;263:1;
198:ll 45:25;84:6;120:10; isotopes 29:lS; 51:20; 295:3
144:5;156:17;158:8; 267:19;268:6;273:1,16;
innovation 25:9,11; 274:20,21;275:16,19;
66:3 Joanna 41:lS
221:6;228:1;238:16; isotropic 106:3; 109:2,7 I. job 49:17,18; 95:16,25;
167:4 243:24;264:17;275:8; 276:4,18; 278113; 279:25
innovations 182:3 282:11,12; 286:8; 291:25 11O:ll 111:4; 121:17;180:12;
295:lO 240:9,19;250:14,14,16;
input 224:13; 281:2; 293:1,25 isotropically 108:24
interested 15:19; 39:14; 288123
283:ll; 296:ll intravenous 58:16 issuance 212:lO
46:19;53:3;100:17; job-issues 237:ll
inside 35:l; 106:25; 133:11;141:21;160:17; intrinsic 80:17,18; issue 4:13; 13:~; 17:16;
129:18;281:12 174:25;188:15,15; 82:20;83:9;84:1;153:22; 19:25;29:14;34:1;69:23. Joe 204:17; 205:1,4,13;
insidious 143:24; 144:1, 191:25;206:1;239:1; 165:12,17 I 70:21;71:24;74:15;80:6, 1 210:20;211:16;230:14;

informative - Joe (16) Min-~-&rip&~ Miller Reporting Company (202) 5466666


Nonclinical Studies Subcommittee of the Hearing
Advisorv Committee for Pharmaceutical Science December 141999

24O:lO; 243:17; 245:7,11; Icinases 20: 10 labeled 36:6; 61:7; 65:6 ayering 234:lO; 237:25; 2181:7,15,21; 282:17
246:12; 270:13,20; 272:4; crind 19:14; 24~22; 44~25; labeling 25:6; 42:15; !38:1 1.ester 79:15,18,20,21;
281:17; 283:23; 287:22; L5:9; 117:25; 119: 19; 60: 14; 72: lo; 73: 17; ayers 109:22 912:18; 93: 17; 117:3;
294:14 131:7,9; 140:19; 154:ll; 147:19;218:8; 258:ll aying 49:17 118:14; 133:8; 246:21
Joe’s 287: 12 163:19; 164:l; 172:14; labels 218:s ays 290:21 I(ets 1Ol:lO
John 6~9; 24~20; 27~23; 178:18; 187:lS; 205:7; laboratories 20:7; ,azabamide 41:21; 43:6 IIeve1 35:17; 36:12; 38:9;
119:9; 231:23; 245:7; 10616; 221:12; 223:16; 144:15 4L3:19; 45:21; 48~24; 51:6,
ead 8:14; 35:5; 73:8,10;
260~15 !24:24; 225~20; 228:12; I .6;74:19;86:13; 105:9;
laboratory 1612; 18:3, 124:7; 160~13; 208:5,16;
Johnson 8O:l; 84:9,25; !30:2,8; 235:25; 23614; 107:8; 138:s; 139:15;
6; 27:21; 41:19;46:2; 120:7,13
90:11;92:19,23,24; 1 140~6,lo; 243:6,7; 148~12; 149:18; 153:22;
37:15; 155:13; 232:15,16; eader 31:12; 79:15
1147~16;248~20; 250:5; 1.60:10; 161:25; 165:5;
93:22; 111:8,17; 113:7; 25619 eaders 123:16; 124:ll
114:lO; 115:12; 117:6,22; ~52~6;256:12,17; 260:13, 1.67:17; 173:15,17; 188~3,
18; 262:3; 263:lO; 264:21; labs 16:16;47:11; 133:23 eadership 182:2 11; 221:22; 237~4; 259: 14;
118:2,15; 121:11,14;
!65:7; 268:12,15; 269:7; lack 60:16;71:21; 84:l; eads 163:4 2!91:8
1266; 133:8,23; 134:s
1 !71:25; 273~20; 274:lo; 145:9; 157:16,17; 183:12; I(evels 148:l; 171:l;
Johnson’s 82:l eak 18:9
1 179:l; 281:19; 283:17; 234:21; 280:16; 282:3,25; 174:7,10; 225:22; 279:5
join 29:21 eakage 249:13,19
1 MAO; 291:9; 292:2; 284:20
eap 67:21; 130:12 I(everage 231:13
joining 47:13 193:23; 294:9 lacked 242~2
earn 17:19; 102:22; IIeveraging 282:13; 293:l
joint 267:13 cinds 2O:l; 26:24; 28:22; ladies 48:6
)0:7; 35:16; 38:18,19,25; 160:6,24; 183:14; 187:15; I(exicon 71:22; 130:22;
joking 136:17 lagging 291:12 189:11,13; 190:2; 192:20; 2!50:22
115~1; 140:12; 144:6;
Joseph 184:19 153:2; 154:13; 158:14; laid 77: 19 !82:13 Iiicensing 45:ll
Josette 102:23; 103:14, 164:10, 11; 167:22; large 11:7; 15:1,8; 22:lO; earned 12:14; 13:5,5; Iiie 45:lS; 287~20
15 188:14; 189:3,18; 195:23; 10s; 48:13; 62:4; 88:15; 14:l; 43:lO; 54:13 Iiies 162:21; 179:l
Josette’s 104: 11 198:lO; 199:16,16; 38:14; 104:5,6,13,14,21; -earning 70~24 Iiieu 234:12
journal 104:12,12 I !24:19; 225:25; 237:16; 116~6; 133:22; 157:7; earnings 252:24 Iiife 45:14; 66:6; 98:5;
1!42:24; 247~25; 256:8,13; 179:6; 238:5; 245:24,25;
journals 40:16 east 31:16; 38~15; 41:4; I.20:22; 121:16; 126:lO;
1!57:19; 260~; 262:18; 273:5,15
Joy 6:12; 132:13; 227:13, j&24; 11O:ll; 111:19; 1.47:22; 163:8; 217:17
1263: 14; 266: 14; 274: 19;
24; 231:15; 274:6; 287:19; largely 45:s; 194:17; 119:24; 121:24; 131:lO;
1764; 278~3; 280~23 I ifeblood 28:lO
294:8; 296: 16 195:1,14; 277~15 145:25; 1469; 152:21;
dnetic 77:23,25; 224:21, Iifetime 147:lS
Joy’s 243:14; 295:25 larger 31:17;44:13; 157:19; 162:l; 181:12;
1 z3 122:14; 179:14; 193:lO; 182:6; 187:7; 188:25; Iifted 55:3; 59:9
judged 205:8 Iigand 51:3
Idnetics 32:5,11; 41:2,4; 194:ll 190:1,17; 195:17; 207:19;
judiciously 226:21 17:16; 51:3,7; 54:14; 55:s; 209:2,11; 212:20; 214:7; Iight 65:25; 100:25;
largest 28:l; 37:23; SO:9
July 101:19 S1:23,23; 78:12; 265:14 115:9,21; 217:17,22; I144:3; 149:6,16,18;
jumpstarting 46:12 Larry 99:14,14,16,19, 218~13; 230111; 253:5,11;
dts 12:ll I152:12; 177:22
25; 100:8,17 260:13; 261:2; 265:ll;
jury 239:22 mew 62~24; 129:lS; Iightening 88:6
Larry’s 101:s 267:8,11; 273:19; 275~25;
justify 143: 13; 263:7; 266:lO; 281:lO Iiked 225:ll; 287122
laser 100:25 284: 17; 285: 1; 2868;
281:6,15 knives-l 109:4 Iikely 40:5,6; 45:13;
last 9:5; 13:5; 43:25; 287:25; 288:3,6; 292:s;
knocking 116:14 ;!09:5; 232~7
81:23; 93:5; 9622; 97:16; 293:9,13
K knockout 265:3 101:19; 112:3; 126:ll; leave 29:7; 47:23; 73:3; Iikes 90:ll
know-if 215:lO 142:11,15; 150:22; >2:17; 126:23; 223:6; Iimit 102:ll; 110:13,14;
knowing 191:25; 241:9, 157:11; 164:12; 199:lO; 254:24; 260: 12; 287:20 1111:16; 114:11,13;
keep 8:14; 9:lO; 63:6;
LO,14; 273:7 218:13; 233:s; 243:22; 1182:20; 203:15
72:ll; 74:2; 95:6; 98:lO; leaves 245:s
100:4; 101:14; 13o:lO; knowledge 9:l; 11:25; 273:3 leaving 75:23; 293:15 Iimitation 119:10,13,18
181:15; 197:16; 198:l; 17:l; 154:14; 159:9; lasted 47: 19 led 23:21; 61:8 Iiimitations 76:3; 148:14,
235:l; 246~4; 247~25; 160:20; 210:2; 221:6; Lastly 81:12 18
left 36:4,13; 43:7; 109:24;
251:20; 254:2; 260:14; 243:9; 253:4; 263: 18; lasts 26: 12 ilimited 12:24; 20:25;
128:12; 166:13; 175:9,12
267:24 264:6; 289:14; 291:8,9 late 38:25; 50:7; 70:3; 74:9; 114:14; 161:21;
keeping 28:17; 33:2;
37:25;74:1; 271~9
keeps 25:6
knowledgeable-in
291:7
known 14:10,14; 15:l;
73:12;78:15; 139:21;
140:15,16; 244:16;
245:18; 278:16
I’
lefthand 42:19;43:12;
57:7; 171:3
legitimate 71:13
186:10; 187:4; 201:22;
218~9; 219:20; 27415
limiting 278:16,21
37:3; 42:13;69:12; 80:5, Lehigh 70:23 line 35:24; 3616; 108:12;
kept 127:19; 256:6 later 9:21; 20:4; 37:2;
13; 90:17; 148:22; 159:7, 47:9; 50:15; 66:13,16; Lehmann 2702; 287:24 127:17; 131:12,14,16;
ketamine 63:25
8; 176:12; 201:7; 209:l; 68:4; 69:17; 77:20; 8620; Leone 107:5 163:22; 164:7; 202:lS;
key 13:12; 1814; 24:13, 211:19 140:18; 147:22; 187:lO; lesion 57:11,13,14; 249:15
14;99:13; 153:1; 170:16
knows 114:19; 241:4,5 190:15; 194:19; 215:15; 58:lO; 82:24; 83:2,7; 85:8, linear 115:25
kicked 188:18
Krebs 19:16; 158:l 249:3,10 l&14; 87:14,19,23; lines 134:17; 251:l
kidney 78:13; 110:19; latitude 112:16; 156:6 88:15; 261:6
KU 6:10 link 18:4; 22:12; 30:14;
117:21,22; 127:9; 170:2 lesions 85:7,18; 89:6,
latter 164:6 59:3; 134:2; 142:8;
kidneys 109:15 lo, 20,24; 91:3,4,16,23;
kill 33:21 L launched 46:13
Laureate 104:15,19,21
113:6; 174:2,16; 261:4,
268125; 269~7
link-if 231:15
kiloelectron 54:3 20,22
lavage 142:4; 166:24 linkage 23:2
kilogram 62:6,6; 172:12; lab 46:19; 82:l; 109:12; less 15:6; 42:21; 52:12;
147:5 Law 218:lO 63:8;68:14; 89:15; 163:l; linkages 22:15
277:20
label 15:2; 18:11; 51:23; lay 7:9; 47:5; 163:l; 164:2; 169:13; 181:9; linked 18:12; 225:s;
Kimberly 4:lO; 5:24;
52:16; 62~2; 65:s; 66~25; 261:11;277:10 191:21,21; 207:ll; 249:lO
1367; 223:9; 251:20;
290: 14 73:12; 218:9 layer 88:23; 197:13 272:17; 273:14; 278:lO; / linking 140:8
-
Miller Reporting Company (202) 546-6666 lwh~~-s~&pm (17) Joe’s - linking
Hearing Nonclinical Studies Stibcommittee of the
iiecember x4,1999 Advisory Committee for Pharmaceutical Science

iipid 141:25 onger-term 209:12 240:2; 243:l; 245:19; 182:12; 257:l i,7;62:12,15
list 9:15; 68:9,14; 145:15; ongitudinal 120:24 249:8; 252~18; 254:l; nainly 186:9 nap 131:20
?67:11; 216:11; 232:3,5, 263:21; 264:17; 276:9,17; maintain 10:12; 157:6; napped 94:22
ook 15:9; 29:13; 33:16;
9; 236:6; 241:25; 242:4,5, )4:16,20; 35:9,13; 36:4, 278:l; 28612 1201 illarch 71:7
6; 243:25; 244~25; 245:2, 13;39:11;41:11;47:13; Ilots 9:24; 14:10,23,25; najor 8:23; 13:7; 17:15, narching 24:6
5; 248:16,20; 255:14,15; L8:22; 50:23; 57:19,25; 222~8 19; 22:5; 32:12,12,17; Ilarcus 93:23; 95:12,14,
275:6 j8:1,5;62:25;80:17,18; Ilow 33:3; 36:18; 62:20; )4:3; 38:7; 64:9; 82:ll; 15,16,22,23; 11622
list-these 244:20 %4:8;86:11,12;87:7,9, 149:17; 152:25; 182:15, 33:15; 108:12; 112:3; nargin 151:1,7,12,13;
listed 57:22; 12020; 20; 88:7,20,23; 89~9; 20; 183:14; 187:25; 188:5; 131:3; 158:8,8; 182:8; 173:16
166~11 )9:15; 1062; 119:12,24; 276:5 L87:22; 190:14; 242:lO;
narginally 120: 12
124:25; 125:22; 128:l; Ilow-dose 280:23; Z57:7; 295:23
listen 281:16; 283:13 131:11; 140:15; 141:16, narker 12:5; 20:5,17;
282:12,21 najority 43:1 ;9:3,4;67:11,14;68:10,
listening 130:17; 284:9 16,17,22; 142:13,13,14;
Ilow-level 225:13 makes 8:9; 174:18; .6; 83:24,25; 105:15;
listing 21619 143:17; 145:20; 147~11; Z49:19; 261:7; 287:lO
148:21,21; 155:8; 165:3; Ilower 36:15,20; 37:19, !24:24,24
listings 202:18 naking 8:23; 9:7; 13:23;
172:7; 17620; 197:11,14; 19; 43:12; 44:3; 225:18; narkers l&7,9,17,21;
lists 59:ll; 145:14; 244:6 15:16; 33:3; 4817;
20517;212:7; 227:16; 282:17 .1:3; 12:1,3,7,13,16;
literally 51:23; 112:15; 128:8,14; 229:3; 233:9, 107:18; 120:19; 122:11, ,3:15; 17:23; 18:7,12;
Ilowering 36:3
264:12 19; 238:23; 247:12,19; 11; 129:16; 232:9; 271:4; 19:4,6,11,22; 20:1,10;
literature 46%; 150:21; ILuminex 153:5 !74:15; 279:12
149:7,7; 25O:lO; 253:3; ;7:18; 149:25; 161:22;
155:9; 188:19; 189:17 z60:19,20; 261:7; 263~11; Ilump 226:16 nalignancies 147:21 !27:4; 230~21; 238:7,8,9;
little 9:14; 15:15; 20:4,12, !64: 13; 265:6,14; 267: 19; Ilunch 135:l; 265:13; nammalian 200:18 !42:15; 246~9; 254:12
20; 22:22; 23:7; 25:23; 169:12; 284:14; 288:3,12; 26714 nammary 170:10,11 narket 110:5,6,7; 200:6
42~22; 43:14; 47:9; 48:15, !91:23; 292:13; 294:3 Ilung 100:18,19,20; nan 16:14; 96:25; 97:7,8; narketing 40:12; 205:17,
20;49:8,14; 50:15; 54:lO; ooked 4:5; 79:9; 82:23; 105:17 ?9:18; 144:9; 145:8; .8; 206:l; 245:20
56:12,15; 59:lO; 61:15; %7:23;89:19; 150:25; Ilungs loo:16 151:8; 160:20; 165:16; narketplace 25:5;
65:1,19; 72:14; 7514; 151:5; 189:24; 193:2; 167:12; 168:l; 169:12,13; .42:23,24; 154:23;
7623; 78~15; 8619; 94~5; 195:14; 196:1n,11; 170:4,8,9; 172:3,16,21;
97:4,14; F&21; 99:lO; 199:ll; 228:lO; 258:16; M 175:22; 204:22,25;
.63:22
narkets 110:5
100:19,20; 101:9,18,25; !69:3 !05:20; 20619; 207:5;
102:22; 103:20; 105:13; nass 96: 15
ooking 28:8; 33:6; 34:3, IM.D 48~4 108: 14; 209:3,6,12,14;
109:ll; 154:l; 158:1,3; 15,22; 35:23; 37:15; 38:9; 232~2;247:23; 253:23 nassage 293:23; 295:4
177:13; 182:22; 184:21; IM3 277:16,21,24 nassage-you 255:8
i2:9; 4615; 51:5; 61:12; nanagement 27:3;
188:8; 222~20; 228:19; IMacGREGOR 6:3,3,23, nassaged 293: 14
;9:19;78:11;81:10;84:3; 25; 7:2,3; 24:6; 28117; 141:4; 163:21; 2Ol:ll
239:2; 249:ll; 264~12; 36:18; 96:9,11; 98~6;
274:10,17; 282:8; 283:15; 75:22,23; 113:l; 114:7; mandate 283: 15 naster 21O:lO
100:15,18; 105:16; 110:5, 117:18,24; 134:23; 156:l; natch 159:25
287:23; 290:25; 291:24; manifest 171:lO
$7; 113:13; 114:5; 157:ll; 221:7,12,14;
293:23; 294:1,9; 295:21 manifestations 225:24 natched 105:9,25
tl6:17; 120:23,25; 227:17,20; 232:ll;
live 5:21; 281:20 129:lO; 132:15,16; manipulate 262:21 naterial 180:5; 183:2;
236:ll; 243:12; 251:20; 109:19; 210:15,22,24;
liver 117:13; 145:17; 134:19; 136:24; 140:3; manner 189:5; 193:15
254~7; 261:14; 269:17,20; !11:2,23,23; 212:19;
170:4; 198:6,7 148:11,13; 149:15,25; manufacture 216:12,20
283:14; 288:14; 290:24; 113:10,12,16; 214:9,15,
living 13:6; 50:24; 57:3; 150~17; 152:l; 161:17; manufactured 101:17;
295:7,20 19; 215:10,16; 217:8;
64:2; 106:18 L98:16; 205:lO; 206:5; 213:17
207:23,25; 229:4,20; MacGregor’s 27:22; 12O:l; 265~2; 277:20,22;
lobes 106:lO 118:16; 157:25 manufacturer 21O:l; ;78:1,6; 281:24; 28212,
233:lO; 241:8; 244~5;
local 71:2,5; 200:13 machine 112:7; 126:9, 213:14,22,23; 214:1,9; 13,22
251:lo; 252:17; 264:4,16,
localization 29:24 18; 273:22,23,25; 280:6; 10; 261:lO 216:24 materials 166: 13;
localized 36: 18 286: 17 machines 126:13; 261:8, manufacturers 127:23 182:24; 208~22; 216:21,
located 41:23; 426 looks 15:11;86:17; 13 manufacturing 204:18; 22; 274:16; 27812; 282:19;
loci 264:22 38:20; 193:14 Macintosh 93:2 212:8; 213:17; 214:2; 283:l
loop 160:24 macromolecuiar 11:22; 216:22; 217:3; 218:5; matter 114:17; 128:17;
logic 229:2
13:8 220:19 22O:ll; 294:4
logical 75:6 lose 125:2; 294:25
mag 216:14 many 13:22; 15:23; matured 293:14
logically 72:lO lost 131:17 17:16,16; 21:l; 22:14;
Magalee 107:4 maximum 39:22; 280:19
logistic 37:9 lot 12:9,12,14; 13:2; 24:7,24; 25:2,6; 31:ll;
14:13; 15:19; Y7:19; magnet 97:24,25; 98:1, may 4:25; 5:5,17; 11:9;
logistical 52:3 34:5; 36:3; 37:24,24; 18:7,12; 39:8;41:5; 48:12;
logistics 72:23 18:25; 19:l; 25:13; 29:18, 2,18; 99:9,22; 100:2,3,5; 40:14; 41:23; 42:l; 48~9;
23; 30:16; 36:s; 38:3; 46:4, 112:lO; 115:7 52:ll; 5617; 59:15,19,
long 7:23; 25:3; 26:12; 74:16;76:2;81:11,11; 19,24; 61:9; 62:19; 64:18;
14; 81:25; 82:10,14; magnetic 50:14; 52:12, 96:7,7; 116:7,7; 117:6;
31:5,12; 33:8;40:24; 83:13; 89:22; 99:4,9; 65:14; 68:6; 70:8; 72:19;
41:19; 43:25; 46:19; 13; 79:19,24; 81:20,22; 123:19,19; 133:3; 141:5;
102:9,16; 103:13; 107:13; 75:1;77:1;79:9;98:20;
48:21; 56:12; 68:9; 89:4; 92:22; 94:5; 105:22; 143:15; 161:14; 169:18;
115:2; 118:24,25; 119:14; 125:2,8,20; 136:25;
95:15; lOl:ll, 12,13,15; 104:2,4; 115:15,17; 178:ll; 179:24; 181:4;
124:21,21; 134:7; 139:5, 137:9; 139:1,15; 142:2;
111:9; 113:17; 177:l; 128:14,23; 129:l; 133:16, 186:21; 192:24; 205:6;
6; 140:4,10,20; 143:6,12; 145:3; 148:6; 149:4;
212:20; 216:8; 232:9; 20; 168:4; 257:15; 260:17 206:16; 215:3; 221:5;
148:6; 149:21; 153:10,11; 150:16; 152:9,10,11;
290:17; 291:20; 293:4,12 magnetically 100:22; 242:lO; 249:21; 268:1,14;
155:16; 178:19; 183:19; 154:8,25; 157:1,24;
101:2 275:16; 280:18
long-running 40:2 187:15; 192:24; 193:3; 158:2; 159:9,20,25;
magnets 97:24; 112:6 MAO 42~20; 43:15,16 160:19,24; 161:6,9,23;
long-term 209:17; 197:20; 207:17; 217:12;
257:19; 258:12; 266:18 219:24; 222:6,23; 232:13; mail 29:9 MAO-A 61:15,18,21; 162:18; 163:17,18; 164:2,
233:15,25,25; 234:13; main 41:22; 51:2; 59:12; 62:11,16 16,19,20; 165:3,5,12;
longer 66: 11; 68: 14;
239:3,5,6,6,12,18; 68:9; 124:24; 179:20; I MAO-B 42:9; 44:2; 61:4, 166:18,23; 167:8; 170:3,
105:17; 179:19

lipid - may (18) Min-U-Scripi@ Miller Reporting Company (202) 546-6666


Nonclinical Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999
- -
12; 171:25; 172:ll; 173:1, mechanisms 14:2,4; metabolite 170:5 168:21; 170:7; 172:13; MIT1 101:18
9,9,17;174:23,24; 16:13;22:24;33:4;37:24; metabolites 225:lO 175:25;185:3;188:12; mitigated 138:12
188:24;189:6;191:5; 159:8;160:18;141:18,24; 189:4;208:16;209:6; mitral 1OO:lO
metabolized 67:2
192:20;198:6;200:3,3,4, 166:22;222:17 210:3,8,15;212:19;
metallothioneine mix 101:14
12,12;207:17,19;210:25; mechanistic 9:l; 17:24; 213:15,24;216:14,14;
250:24,24 217:10,11; 219:19; mixture 100:25
214:17;229:5,5;232:15; 1815; 52:18; 64:22; 67:ll;
233:11,25;234:6,14; 68:3; 141:l; 226:7,14 meter-squared 172:13 220:13; 221:16; 222:19; MMEs 235:17
237:22;238:7,19;241:14; mechanistically 143:24 method 72:16; 197:21; 223:1,24; 226:13; 227~20; moclobemide 62:ll
244:23;245:18;246:7; 215:12,22; 219:21; 261:3 228:4,7;231:24;232:8; modalities 246:21; 262:6
Med 610
248:7;258:16,18,18; methodologic 74:16 234:17;236:15;242:9,13; modality 247~3; 248~1
mediated 32324 243:8,8; 247:13;248:9,
2644:8,11,23; 273:18; methodologies 79:l; mode 186~4
275:13,17; 277:15; mediators 116:18 21; 251:9,11; 254X$
123:24; 159:23 model 17:20; 20:16;
288:14;290:17,19; medical 2616; 40:16; 255:12,21; 257:lO;
98:4;259:7;260:5 methodology 72~20; 260:24;261:18,19; 57:lO; 58:8,19,19,19,23;
294:16 75:6;129:19
medications 265 263:22;267:20;283:24; 63:24;66:20;96:12,13;
Maybe 44~9; 82~22; 867; methods 70:20; 157:21; 105:3;126:7;144:24;
93:4,11; 112:18; 115:4; medicine 3O:ll; 163:22 288:17,25;289:22;
161:24; 166~10; 180:18; 292:16;294:18,22; 145:1,2;149:10,12;
117:3;130:6;140:20; medicines 72:8; 160:23; 171:5;186:8; 187:l;
195:ll; 19613; 19217, 295:lO
142:7;151:9;182:17; 163:23 230:15,17;232:19;247:9,
185:6; 192:17;194:19,19; 18,19; 199:7; 20013; Imigrated 58~22
meet 150:7; 180:7; 278:2; 204:2;238:23;241:15 12,13,19;248:3;252:10;
201:23;221:14,15;222:7; 296:16 Imild 164~9 26618
226:15;228:18;231:14; metric 103:7; 104:8;
meeting 4:7,7,8,14,15, Imilligram 55:12; 172:12 models 12:21; 16:12;
235:4;237:18,18;238:22, 168~23; 169:ll; 171:22;
16,21,24;23:9,9,19,21, 172:lO Imilligrams 43:5,9,13; 18:3,6; 64:5; 91:9; 93:8;
22;241:16,20,25;242:1, 22;28:8;32:7;50:4; 111:9, Ij1:13; 62:6,6; 172:12 95:ll; 96:1,7; 99:8;
14;247:1,19;252:6,7,16; metrics 99:23;100:4;
11; 122:14; 126:17; Imilliliter 51:13 108:13; 117:13,14,14;
253:4,6; 261:20;263:15, 129:22,22; 146:14,16; 162:5,10 123:25; 132:18,20,21,25;
17,23;264:3,7;267:18; 156:20; 157:9,11; 200: 1 I mice 99:7; 133:lO; 265:3 Imillimeter 86:7,7; 94:25;
‘ >5:1;97:25; 105:15; 133:5; 143:19,19,21;
275:10;276:14,24; 211:17; 281:18; 287:15; microarray 140:4; 146:1, 149:8; 175:2; 181:16;
279:15,19;282:25;283:1; 288:3,11; 290:11,16; ;114:14,14,15
9,15 184:25; 232:15,16;
284:17,20,22;288:10,12, 291:2; 294:19; 29514; Inillimeters 51:16; 95:2
microarrays 158:14 238:17; 244:9; 245:17;
18;292:14;294:10;295:1;
296:lO Inillimolar 84:2 247:20;252:22;255:2;
296:8,13 microbiological 124:20
meetings 2&l; 122:2; Imillion 112:11,12; 263:17
MDR 37:4; 38:l microbiologist 207:23
193:24; 251:25; 267:4; 1115:19,21; 124:19 modern 19~4
mean 33:20;71:24;91:5; 288:19; 294124 microCT 133:ll
Inillions 35:3; 39:5 modes 134~3
117:24; 124:lO; 165:7; micrographs 105:2
meets 196:7 Inillisecond 101:5 modification 60:15,22;
234:14,19; 239:19; 278:9; micron 95:4,4,5; 100:9;
282:15,16,21 megahertz 257:18 Imilliseconds 101:23,25; 61:9;85:24
101:6;105:7,7,8;106:8;
meaning 73:12; 282:8 Mehta 188:19 102:l; 103:11,23,23 modified 103:20
108:24; 109:14; 117:21
means 40:21; 102:12; member 6:10,20; 22:8; iMilwaukee 98:17; 99:2, modifiers 167:l
microns 86:5; 102:14;
129:6; 177:9; 208:13; 79:7;98:16;156:15; 15 modify 122:8; 284:13
104:16; 107:ll; 109:21,
217:24; 249:18; 252:19, 157:15;284:21;287:6; Imimic 132:22; 186:3 modifying 60:13
24; 110:12,12,19; 113:16;
20;267: 15 291:19 Imind 28:16;72:11; 74:l;
116:2,2; 117:15 modulate 34:l
meantime 292:15 members 29:5; 175:25; 141:14; 185:24; 197:16;
microPET 55:20; 133:ll modulated 37:16
253:3;289:22;294:11 198:l; 236:12; 248:l;
measure 1O:lO; 12:11, microphone 223:lO modulation 38:lO
15; 18:3; 19:6; 58:4; 60118; membrane 142:2; 247:2 microphones 5:20
254:2
modulators 32:14,22
62:15,16;68:24; 1OO:l; memory 128:20,25 Imindful 282:lO
115:ll; 171:11;224:23; mention 58:11;76:12; microscope 11O:l; molecular 11:21; 13:21;
Imine 48:16; 173:25
230:20;234:18;266:3,4; 77:21; 79:4; 93:ll; 260:17 19:6; 50~19; 108:ll;
Iminimal 52:lO; 273:12;
278:7 133:14; 184:1;210:12; microscopic 190:13 110:7; 149:5; 152:19;
276118; 281:5,11; 282:12 161:25; 165:4; 168:14;
measured 14:16; 15:24; 218:23; 224:21; 231:19; microscopy 81:21,22;
Iminimally 183:8 212:17; 213:2; 254:12;
18:9,22; 52:12; 59:19; 244:4;245:23 82:2;84:5;92:21;93:19;
Iminimize 64:15;211:12 259:15; 267:ll; 273:5
60:2,5;61:7;63:22;72:23; mentioned 12:20; 18:18; 94:4;95:4;96:22;97:6;
100:9;102:3;115:5,10; Iminimizes 64:10,11 molecule 51:23;83:23
93:16;120:6 58:4;60:10;70:7;77:22;
measurements 10:12; 79:3;80:12;83:8;86:22; 116:19; 122:ll; 125:21; Iminimum 39:20; 41:4; molecule-based 246:25
11:1;15:16;18:4;80:20; 90:10;123:10;124:8; 133:16,21 200:18; 212:14; 217:22 molecules 13:lO; 14:4;
107:23; 116:21 130:21;138:19;162:24; microscopy-but 125:9 IMinnesota 116:4 52:16; 104:6; 246:l
measures 52:l 192:10;205:1;224:3; microseconds 103:17 Iminorly 13~16 moment 30:13; 65:20;
255:14;262:20;292:6,17 microstructure 104:9 minoxidil l75:4 93:2;94:14;157:16;
measuring 15:20; 59:16;
63:lO; 68:23; 76:16; Merck 73:22 middle 35~ minus 69:13 158:12,22;159:3;163:14;
104:9;154:5,6; 215:20; mercuric 117:14 172:25;192:6,12;201:23;
Midway 98:23 minute 10621; 282:5
231:4 merits 205:8 286:7
might 23:10,15; 28:22; minutes 7:7;37:6;106:4;
mechanism 17:20; mesenteric 150:4 money 72:19; 163:5;
46:22;47:23;48:11;75:3; 118:lO; 136:19,19;
23:24;33:1;53:10,19; 239:6;245:19
mesh 146:25 77:10,21;78:10; 93:23; 221:ll; 284:lO
56:24;59:20,25;60:1; 101:3; 102:14,14; 109:25; monitor 14:16; 21:25;
message 276:7 miss 294:22 139:4; 147:23; 148:l;
77:8;88:1;125:18;162:4, 113:3; 119:ll; 127:14;
met23:8;266:6;279:6 missed 104:19,22; 15O:ll; 152:13; 211:ll;
9; 165:ll; 175:20; 181:13; 128:7; 131:16; 143:3;
meta-tyrosine 58:4 244:13,16 214:14; 216:2; 237:15;
260:13; 288~24; 289~8; 145:2;148:10;150:18;
29618 metabolic 50:19 152:25;156:17;157:3; mission 75:12 266:ll
mechanism-based metabolism 28:2; 29:24; 161:10;162:2,9;164:9, Missouri 48:16 monitoring 13:15; 41:l;
42:13;156:24 I 51:3;166:6,7;265:6 10; 165:24; 167:15,17; mistake 114:11;129:16 84:18; 90:8; 137:3; 15O:ll

Miller Reporting Company (202) 546-6666 Min-u-scrip@ (19) Maybe - monitoring


Hearing Nonclinical Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science

monitors 84:19 179:lO; 186:6; 203:2; Imultidisciplinary 182:7 20,23; 30:5; 33:13; 34:22; neurotoxins 85:6
monkey 15l:ll; 169:13; 218:13; 227:14; 229:15; IMultiplanar 84:7 38:19; 39:11; 42:lO; 46:3, neurotransmission
f70:3,6,7,12 232:7; 237:l; 239:23,23; 5;65:16;70:16,17;71:14; 58:6
Imultiple 170:25; 172:2;
269:l; 27023; 273:17; 74:2;75:1;76:17;81:5; nevertheless 161:9;
monoamine 41:22; 42:4 182:16; 191:l; 197:13,19;
274:ll; 283:8; 286:25 275:2,2,3; 277~4 84:2; 91:9; 119:6; 121:8; 168:3
monograph 212:17,23 124:lO; 125:13,15,21;
mostly 114:2; 122:12 Imultiples 173:21 new 7:10,11;8:3; 101;
Monroe 188:19 127~25; 128~5; 130:19;
motion 104:23; 296:15, Imultiplex 118:8 11:20; 12:3,13,16,21;
month 104:12; 117:2; 131:3; 140:19; 14624; 13:15; l&3,3; 17:25; 18:l;
16
14614; 194:19; 209:11, Imultitude l59:4 147:22; 148:17; 153:9;
Motor 98:23; 12820 25~24; 27:3,14; 28~4;
18; 276~4 Imuscle 78: 13 154:8,19; 155:18; 157:18, 30:23; 31:15; 39:15;
mouse 55:18,22; 97:2,3, 22; 158:16; 163:24; :Gp:6;
months 35:22; 41:17; Imuscles 109:16; 150:13 41:16;49:13,21; 50:7,15,
4,5,8; 108:10,13,14,24; 178:17; 179:4; 180:13;
60:25,25; 61:5; 69:16; Imust 17624; 195:19; 18; 61:6,7; 69:25; 70:19;
1109; 111:20; 145:l; 182:3,12,22; 183:6,7,23;
112:25; 117:12; 118:3,7; 259:9; 270: 18 72:1,7;81:6; 120:16;
149:8,10; 151:lo; 172:4 184:3,12; 189:13; 191:1,
120:7; 122:9; 202:ll; Imutational 12:14 121:18; 123:25,25; 133:3;
209:14,17; 294:25 mouthpiece 96:19 4; 197:23; 198~4; 199:4, 152:9; 159:24; 160:7;
move 17~5; 21:6,9,20; Imutations 12:15; 141:18 16; 202: 18; 205:7,24; 162:25; 163:21; 167:4;
morbidity 154:22
23:23; 24:ll; 27:14; IMyelin 88~19.20 20610; 209~22; 212:15; 170:25; 176:2,13; 177:l;
more 7:18; 9:14,16,21; 213:25; 215:19; 224:25;
47~20; 48~14; 64:25; Imyocytes 175:13 17&l, 5,15,23,25; 179:2,
102; 12:7; 15:6; 19:25,25; 79:13;96:17; 102:14,16; 225:3; 228:3; 231:14,22;
Imyself48:15; 129:21; 5; 180:14,14,17,19,24;
20:8,9,20; 21:lo; 22:22; 104:6; 116:15; 12019; 232:20,24; 233:8,13;
278~25; 283:19 181:17,19; 182:2; 184:lO;
27:2,11; 29:14; 31:22; 131:12; 151:20; 155:20, 235:12; 2364; 237:5; 185:14; 191:14; 197:17;
35:11;38:3;40:5;41:17; 23; 181:8; 184:17; 222:16; 238:6,24; 239:14; 241:20; 198:9,12,14,16; 199:3,
42:21; 43:7,22,23; 45:11,
16,17,24; 46:14,14;
240:4; 243:9; 248:19; N 242:4,20,22,24; 243~4;
245:1,1,3; 247~18;
20; 205:21; 212:16; 213:l;
254~4; 255:23; 257:l; 218:9; 219:7,10; 240:16;
47~18; 49:24,24; 50:16; 259:25; 272:12; 279:14; 248:15,22,23,24; 251:1, 241:8,12; 242:lO; 259~7,
56:15; 57:19; 58:3; 59:l; 289:4; 293:25; 296:2,3,9, n’s 9517 22; 252:9,11,13; 254:9; 12; 260:5; 264:8; 265:ll;
63:6; 64:18; 65:1,10,19; 13 IN3 199:17; 272:5; 28O:ll 256:11,25; 258:2; 259:10, 267:6; 276:9,19
73:17; 74:17,25; 8614; moved 116:6,13,18 Inail 75:5 18; 260:13; 267:ll; 272:6;
Inewer 195:ll; 19613
92:4,6;98:21;99:11; 276:1,13; 277:6,19,25;
moves 102:9; 1769 Inailing 145:4 Inewness 28:5
110:18,21; 112:4,13; 278:16,17,18; 279:16;
moving 8:18; 101:20; Iname 6:12; 35:25; 156:3, Inext 24:ll; 80:6; 97:4;
118:4; 120:7; 124:21,22; ‘j, 11; 213:14,25; 216:24;
280:3,5,14,17,22;
126:21; 130:3; 132:18; 104:2; 106:ZO; 110:3; 282:lO; 289:17; 291:9,12, 110:24; 112:24; 118:7;
134:15; 137:9; 141:2; 119:l; 137:l; 245:5; 223:ll 16,17; 292:18,25; 293:22; 121:8; 136:12,24; 149:2;
142:8; 149:21; 151:19,20, 256:l; 270:24 Inamed 236:18; 242:2 295:18 159:14; 188:ll; 230:7;
20; 155:3; 159:14; 160:17, MPT 58:19 Inames 294:20 needed 75:7; 123:15; 254:5; 288~11; 290:10,16;
22,25; 161:17,18,25; MPTP 56:17; 57:1,3,10; narrow 294: 17 182:15; 200~8; 201:14; 291:l; 294:18
162:ll; 163:2,23; 165:2, 58:9 204:23; 205:3; 206:4,20, INF 212:23; 216:17
INational 6:14; 28~13;
22,23; 168:19,21; 169:14, MRI 80:4,9,11,11;81:2, 111:19; 79:4;90:19; 21; 211:5; 212:18; 215:6; INIAID 245:24
16; 176:19; 179:3,19; 20; 84: 1,8,19; 86:6,6,11; L58:19; 216:17 216:7; 231:25; 271:5,7; Inice 147:ll; 221:8;
181:3,23; 182:18; 183:2; 92:9,16; 93:19,19; 94:4, 272:16; 285:6,25 240:19; 294:12; 296:3
Inaturally 53:9
185:l; 188:7; 192:6; 7,8,16,24; 95:lO; 96:17; needing 12~6; l91:6
Inature 77:6; 8014; 88: 1; Iniche 264:23
196:l; 198:15; 200:25; 116:25; 121:21; 129:3;
143:25; 157:23; 160:22; needless 82:15 INicomed lOl:19
203:12; 214:7,22; 215:16; 132:3; 171:15;223:15
217:12; 225:21; 22611, 164:19; 171:18; 192:l needs 2621; 126:17; INIEHS 146:12; 157:13;
MRM 81:22; 82:5,9; 148:7,11; 149:21; 204:6;
13,23; 240:12; 242:9,13; nausea 244:ll 158~18
83:20; 85:l; 86:3,12; 209:l; 211:l; 212:20;
248:9; 249:ll; 250:9,10, 87:14,20;88:12,21; INC2 149:7 Inifty 14:25
13; 251:12; 254:13,16; 227:13; 250:21; 251:7;
89:11,19,20,24;91:6,17; INCE 181:ll 278: 20
night 98~23; 164:12
257:24; 258:3,15; 259:8; NIH 22:10,12,17; 70:9;
92:2; 94:8,9,16; 96:18; INCTR 90: 19 negative 38: 11
260124; 261:7; 265:23; 79:7; 133:ll; 144:17;
131:23; 133:10,10; INDA 205:19; 207:l;
271:14; 273:14; 277:l; neglected 81:16 14617; 158:20; 233:14,
200:21; 223:15; 247:3 218:19,19
279:9; 283:4,17; 287:4, nephrotoxicity 158:15; 17; 264:6; 267~22
10;290:11;295:11,17 MRN 266:3 INDAs 82:9 229:6; 293: 18 nine 469
more-l 200:24 MTD 150:8; 272:22 Inear 32:25; 73:20; 294:ll net 63~5 Nissl83:5; 88:4,17
Moreover 62: 1 much 19:17; 27:9; 29:17; Inearly 106:3; 291:7
43:21; 48:23; 67:14; Network 122:21; 245:23 nitrogen 101:14
Morgan 155:23,25; Ineat 102: 10; 129: 18 networks 264:5
70:11;75:21;77:19; nitrogen-13 51:21
156:l; 180:12; 224:4;
79:21; 81:2; 88:5; 92:5,6; Inecessarily 152:20; Neurology 41:20
225:ll; 232:12; 259:24 168:2; 181:ll; 189:2; nitty 251:16,17
99:20; 101:8; 102:12; neuropathology 82:13;
morning 6:22; 24:9; 32:7; 202:2; 218:l; 219:20; nitty-gritty 292:19
119:5; 125:22; 142:ll; 263:21
47:lO; 142:12; 158:l; 177:2,11; 178:17; 181:24; 243:23; 244:6,11; 286: 15 NMEs 235:7
168~23; 257:4 Inecessary 68115; 69:5; Neuropharmacology
184:25; 189:13; 207:16; NMR 80:18; 85:25; 95:24;
70:15;72:5; 95:18; 99:6; 79:15
morphologic 10:14; 11:5 212:6,6; 216:19; 234:14; 257:12; 259:9
122:7,24,24; 141:6; neurotox 112:23;
Morris 6:19 239:14; 241~24; 245:l; no-toxic 172:2
189:4; 199:ll; 201:22; 242~19; 244~8; 246~20;
mortality 154:22 250:9,16;2562; 257:10, Nobel 104:15,19,21
209:16; 215:4; 233:2 247:4; 266:12
21; 262:15; 263:6; 268:2; noble 165:2
most 25:11,18; 26:12, neurotoxicity 56:21;
272: 17; 273:4; 276: 14; necessitate 191:5; 204:8
14,17; 30:12,17;31:1; 24622; 265:15; 266:l nobody 163:4; 267~9
279:9; 280:23,24; 285:19; necropsies 166:18
34:21; 37:8; 40:14; 51:18; neurotoxicity-now noise 56:7; 113:22
52:14; 53:3; 76:9; 83:22; 287:3; 291:25 need 5:ll; 9:9,10,10;
multi-laboratory l59:16 15:20; 16:5,9,12,14,18; 293:19 nominations 21:13
111:18; 118:l; 122:9;
145:2; 163:12; 165:15; multicenter 68:ll; 17:3,12,22; 18:1,7,15; neurotoxicologist 82:ll non 190:8; 194:2; 196:19;
167:ll; 171:22; 176:16; 122:23 I 25:7; 2620; 27: 12; 29:4, neurotoxin 5620 199:17; 202:2; 278~22

monitors - non (20) Min-U-Script@ Miller Reporting Company (202) 546-6666


Nonc&xical Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December l&l999

non-clinical 200:24; now-and 134:l DECD 195:16; 234:9; I171:14; 174:3; 175:2,3; opportunities 8:20;
203:23 277~2 I178:4; 179:6,20; 180:9; 11:18,19; 12:23,25;
nuclear 29:16,21; 30:9,
I181:3,18,24; 182:5,7; 16:24; 21:l; 25:16; 32:13;
nondestructive 109:9 11;49:4;70:22;75:11; If-1 274:lO
I183:10,16; 184:8,11; 45:18,19,20,24;46:17;
non-imaging 193:21 260: 17 of-just 153:4
1185: 16; 186:6,11,14; 76:2,6; 110:17; 131:5;
non-INDs 283:25 number 10:6; 11:12,17; Df-well 103:15 1187:6,9,13; 189:2,8; 180:25; 183:13,24;
non-oncology 193:21 23:14; 29:13; 3O:l; 32:21; Dff 5:22; 6~22; 28:15; 1190:15,15,21; 191:19; 259:21
34:23; 48:13; 49:22; 10125; 47~2; 64~18; 6712; 1192:15,17,20; 193:25;
non-QA’d 202:13; 203:3; opportunity 11:23; 12:5;
51:18; 55:9; 56~21; 64:14; 79:14; 111:3; 129:12; 1194:ll; 195:6,12,21;
271:8 19:10,24; 20:23; 22:l;
79:3; 82:7; 85:5,18; 89:23; 153:4; 231:21; 240~25; 1196:15; 197:8,11,16;
non-W’s 202:6,10 26:8,13; 28:lO; 37:13;
90:16,21;92:11;93:17; 242~5 1198:23; 199:25; 200:4,5,
non-rodent 187:l; Ii,18; 202:10,24; 203:9, 48~7;49:22; 72:25; 75:15;
95:23; 110~5; 113:9;
191:20; 200:19 off-line 127:14; 290:15, 79:8; 94:2; 120~17;
116:17; 119:18; 120:20; ;13; 204:6; 205:8,8; 122:16; 124:12; 128~11;
15; 291:l
non-target 165:21 145:14; 147:17; 153:23; 1r!07:19; 209:18; 210:12; 129:23; 130:6; 134:10,20;
158:18; 167:9; 178~23; offer 1368; 170:23 r1111:16; 212:22; 214:22;
non-toxic SO:10 136:8,22,23; 177:ll;
non-value-added 179:5,6,6; 180~1; 184:3; offers 256~5 1I119:21; 221:20; 224:3,17;
I 178:8; 183:21; 184:21;
234:23 188:22; 192:13; 193:15; Qffice 5~7;64; 27~22 1226% 227:8,9; 228:12;
193:24; 211:17; 224:ll;
Nonclinical 4:4; 8:5,7; 219:21; 229:8,8; 235:14; Dften 13:9; 17:16,20; ‘rZ29:8,14; 232:13; 233:18,
226~22; 272~3
245:21; 253:6; 260:7; 40:23; 81:21; 87:15; 119; 234:15; 236:1,11;
11:l; 17:13; 22:24; 23:1,2; r opposed 207:14; 225:18;
273:15; 274:13; 279:22; 169:2; 1867; 193:8; 1137~24; 240~5; 24119;
29:14; 35:16,17; 38~21; , 241:2; 260:22
292:5 194:17; 196:12; 212:5,18; 1:42:1,9,10,23; 244:8,8,
41:12,15; 47:6,12; 5O:lO; optical 105:2; 108~5;
I12,14,21,23; 245122;
53:3; 67:10,23; 68~3; 70:5; numbers 64:19; 176:19; 214:6,24
2M&3,7,18,21; 24715; 11O:l
7617; 143:16; 154;6,14; 178~25 oftentimes 143:lO r
‘ ?48:15,24; 249:5; 250:18; optimize 35:5; 70:19
155:3; 184:ll; 228:22; numerous 116:23 old 41:17,17; 111:8; r
1152:17,19; 255:14; optimizing 91: 11
240:17,18; 289:15,18 I
113:13; 141:7; 235:l ‘ 256~25; 258:6,7; 260~24;
nondestructive 84:5; optimum 117:19,25
87:20 0 older 50:16; 179:3 1!61:23; 262:1,6,19,23;
r
1163:20; 266:1,10,13;
option 229:19
Dmitted 166:12 r
nonetheless 32:ll; 1Z67:2,17; 268~17; 269:18; options 18622
38:lO o’clock 99:l; 135:2; on-about 14:24
1?70:20; 271:14; 273:8,14; oral 191:3; 217:13
Dn-the 227:7 I
nonfatal 164:19 136:6 (I274:12; 275:1,9,20; orally 207:15
nonimaging 258:24 O’Hare 99:3 Dn-board 71:4 ‘ 176:3,8,13,15; 281:9; orchestrate 122:14;
Noninvasive 12:19; once 5:22; 30:4; 40~13, ‘ 282:9; 285:12,14,22; 123:2
objective 8~3; 64:15;
31:21; 32:3; 45:l; 49:21; 14; 44:10,12; 47:6; 61:22; ‘ 286~2;288:2,2,15;
69:14; 168~21; 281:21 Order 4:2; 29:3; 47~6;
56:25; 59:5; 61:3; 64:5,10; 68:17;99:21; 117:2; 192~14; 294:24
objectives 6:24; 7:1,17; 52:5; 56:lO; 58:17; 59:2;
76:18; 77:6; 79:13; 80:14; 131:16; 153:l; 154:13; 4me-half 148:19 68:2;69:15;70:19;79:11,
22:21,23; 75:13; 158:21; 186:16,17; 231:3; 238:4
171:15; 183:20; 257:ll; 178:5; 184:9; 196:8; IDne-month 197:6; 11;89:3;92:16;94:11;
259:3,20; 290~10 224~9; 269:9; 276:13; oncogenicity 239:4,12 209:lo; 231:9; 274120 103:11,15; 109:3; 113:16;
nonspecific 61:21; 288:3; 290~21 oncologic 194: 16 IDne-year 193:17; 197:7 1162; 124:15; 128:18,21,
165:20; 234:16 observable 43:16 oncology 32:23; 54% Ianes 105:23; 140:11,11; 25; 131:ll; 166:21;
noon 135:3 185:25; 192:23; 193:2,18, 205:25; 230~25; 234:17; 167:18; 233:3; 235:13;
observation 163:17
normal 13:22; l5:6; 20; 194:3,20 235:22; 236:16; 238:8; 251:2; 264:14; 286:5
observations 39:25;
9611; 113:2; 132:16,17, one 9:15,24; 1O:l; 13:2, 241:20; 244:9; 248:7; orders 24:6
125:14; 148:23; 1163:ll;
23; 171:4,6; 188:16; 3,20; 14:6; 15:23; 17:15; 255:11,16; 295:5 ordinarily 215:5
177:lO; 19O:ll
237:13; 272:8,20; 274:1,3 20:4,15; 27:21; 29:8,14; IDngoing 146:24 organ 83:23; 90:18; 97:7;
obtain 80:16;84:11;
normal-these 96:lO 3O:l; 31:l; 32:12,17; Ionly 5:22; 14:ll; 26:8; 109:20; 196:lO; 259:13,
86:17;87:11;89:3; 162:l
normally 260:23 34:23; 36:l; 37:1,25,25; 28:6; 37:1,6; 43~22; 49124; 16; 260:19; 278:16,21
167:18 40:5,20; 42:1?; 46:20;
normoxic 65:22,25; j5:lO; 59:25; 60:12; organic 51:23
obtained 5:5; 41:13; 48:17;50:11; 51:18; I63:25; 65:ll; 81:9; 82:18;
66:10,15,22 82:19; 89:5 57:19; 59:1,15,24,24,25; I98:19; 116:13; 123:21;
organism 83:23
not-our 245:17 obtaining 89:15; 90:16 60:4; 63:24; 65:25; 66:5; 128:24; 131:20; 133:lO; organisms 13:6,13
note 104:7 obvious 67:24; 69:14; 67:l; 73:24; 74:17,19,25; 163:8; 164:22,23; 171:5; organization 6:7,13;
noted 5:12; 224:17 71:11;81:4; 272:ll 75~3; 7617; 77121; 78~20; 178:9; 187:6; 191:3,3; 30:6,6,23; 123:2
notes 189:25 obviously 13:12; 45:19; 82:4,11,13,15,19,21; 193:4,18; 201:20; 202:14; organizational 23:9
64~20; 72~22; 82:19 84:1,18;85:10;86:15; 203~2; 227~2; 238~20; organizations 22:5;
notice 1OO:lO; 148:15;
Oc 255:13 87:2,3,13,19; 90:6,7,21, 239:ll; 246:ll; 257~22; 78~24
174:12; 189:17
23;96:1;97:13,23;99:13; 266~19; 268:15; 271:16;
noticeable 88:12 occasion 162:13 organizer 24:13
100:13; 102:23; 103:15; 274:25; 292:18,22
noticed 79:9; 145:20 occasionally l&3:8 106:19,24,24; 107:3; organs 91:15; 110:18;
onset 101:23; 139:4 190~14; 235:9; 261:12,12
notion 50:9; 185:22; occupancy 55:6,8 108~19; 109:25; 112:21;
113:2,10,19; 114:17; onto 122:lO; 239:24 orientation 31:16
194:lO; 199:lO; 270:23 occupied 35:7
115:3,20; 116:21; 117:8; open 21:12; 136:5,6; orienting 87:lO
Novartis 95:12; 116:24; occur 138:21; 148:22;
118:4,22; 121:ll; 122:l; 157:6; 251:25
150:22 155:2; 163: 10; 238:9; original 291:19
266:5 125:8; 126:16,21; 128:7, opened 22~22 ostensibly 74:15
novel 123:19; 167:4;
196:16; 197:12; 198:15; 14,16; 129:4; 130:20; opens 19:4
occurred 58:13; 146:16; others 51:22; 62:22;
132:3,6,15; 137:8; 138:7; operate 23:15
190:16 77:17; 160:17; 189:8;
14O:l; 143:3,5,13,17; operation 97:21
November 157:9; 205:13 occurring 82:25; 85:15; 144:2,19,21; 148:10,24; 294:16
novice 260~6 147:14 149:15; 153:2,4,23; operations 7: 11 otherwise 34:20; 72:20;
novo 241:22 occurs 139:9; 149:20 155:9; 162:19; 164:12,13, opinion 165:ll; 289:3; 78:25; 101:3; 200:3;
now-about 96:lO October 2462 14; 165:8; 168:3; 169:2; - 295:21 264~22

Miller Reporting Company (202) 546-6666 ~h-~-scrip~ (21) non-clinical - otherwise


Hearing Nondinicd Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science
ought 22:15; 146:21; overload 96:12,12 participant 5:2,10 172:23; 271:24; 281:22; 142:25; 158:7; 159:8;
241:16,21; 254~2; 267:9; overlooked 221:25 participants 4:17,20; 286:5 160:14; 161:16; 162:17;
284:6; 288~10; 289:14 overly 188:15 5: 10,14 patients 25:7,22; 26:4; 166~16; 167:18; 168:4,7;
ourselves 6~; 95:19; participate 5:3; 71:3,5, 38:8; 39:6; 4218; 132:22; 173:3,13; 175:24; 198:6;
overview 185:l
234:13; 288:23 13; 179:16; 295:ll 163:10,18,23; 176:21; 235:18; 242:8,10; 255:20;
overwhelm 39:23; 2663
out 7:9;9:15; 10:3; 12:lo; participated 233:18 179:16; 181:24; 182:3;
118:lO
15:18; 17:9; 20:24; 21:l; 186:19; 274:13; 277:23 perhaps,we 238:6
overwhelming 114:l participating 157:5;
23:24; 25:23; 27:1,10; 160:3; 295:17 pattern 169:3; 175:lO; period 47:9; 52:7; 58:16;
29:2,7,20; 304; 33:2,24; own 20:7; 27:5; 74:13,14; 235:lO 60~18; 89:4,12
3622; 38:7; 39:5; 43:16; 184:6; 199:7; 205:8; participation 75:15;
157:lO patterns 15:9; 159:3,25; period-was l93:17
46:9,16; 47~23; 48:18; 229:l; 25212; 25618
168:6; 250:4 periodically 251:23;
49:ll; 6023; 62:20; owns 182:9 particular 4:25; 7: 14;
68:23; 75:9; 77:19,23,24; 15:13; 1615; 32:4; 34:0, pause 16:21; 94:14; 252:5
Oxford 151:25 291:24
83:5,12; 86:16; 88:3; 11; 38:8; 39:15; 41:21; periods 101:15
89:17; 95:23; 96~2; oxidase 41:22; 42~4 43:10,11,19; 49:20,23; PD 31:18; 32:8 peripheral 166:20
lOOZ22; 103:5; 108:4; oxygen 14:13; 101:14 55:14; 73:24; 74:22; PDI 150:22 periphery 78~10
109:20; 112:7; 122:6,16; oxygen-15 51:21 75:14; 80:19; 83~2; PDI-IV 15023 permanent 98:16
12621; 128:4,12; 131:6; oxyl115:19 125:23; 129:4,6,25; peak 190:15 permit 50~19; 77:2
132:9; 133:8; 134:11,17, 134:12; 163:3,19; 169:8,
18; 136113; 137~22; 141:9; 24; 171:10,24; 172:ll; pediatric 19&l 1 permits 5:3
145:13; 146:16; 147~5; P 174:6,14; l&1:25; 189:5; peel 109:3 permitted 64:12; 295:8
152:3; 153:24; 183:7; 195:19; 197:3; 222:14; pending 202:6 persist 117:12
185:3; 192:17; 195:16; 227:15; 228~13; 232:25; penetrate 302
;;gly8c;protein 36:2,10, persisted 99~9
198:6,24; 200:21; 205:2; 252:4; 263:5; 265:5;
; : people 16116; 21:14; persistence 99:20
208:4; 213:24; 219:4; 26614; 275:3; 292:7,13
223:14; 224:2;228:6; P-gp 37:4 30:20; 32:6; 34:5; 37:8; persists 104:4,8,24
particularly 31:18; 39:21,22; 41~24; 56:21,
229:21; 233:17; 239:22; p.m 135:4; 136:2; 296:22 person 47~4; 207:14;
32:14; 35:15; 163:18; 22; 61:8; 69:22;71:1; 89:8;
241:7,17,20; 242~25; pace 181:16 186:18; 191:20; 196:19; 257:5
243:8; 245ri8; 249:20; 96:20,21; 97:19,20;
package 129:19; 193:10, 197:17; 224:ll; 257:17; 100:15,21; 112:9; 115:17, personal 127:16; 289:2;
250:3; 252:20; 253:6; 25; 273:8; 279:25; 280:2 258:3; 264:21 23; 116:1,3; 118:25,25; 291:18; 293:21
254:18; 255:14; 256:8,23;
257:1;260:6;261:11,20; packaged 201:15 parties 182:9 120:16; 121:9,18; 125:17; personally 27:5; 32:13;
262:8,21; 265:10,18,21; page 240: 16 partly 189:16 126:11,24; 127:6; 130:7; 250:8
266~7; 267:20; 271:12; paging 106:7 partner 25:16; 74:5; 134:16; 137:22; 143:3; persons 78:24; 181:4
276~9; 277:lO; 283:8; 75:ll; 78:25; 253:3 157:5; 160:11; 179:24; perspective 19: 13;
paid 123:24 223:8; 236:25; 241:12,24;
284~2; 287:5,5,13; 290:1, partnering 26:6; 27:4,6; 24:12,17,18; 117:18;
pair 57:15;93:f 244:15; 253:5; 254:20,21;
12,21; 291:13,16; 292:14; t44:6; 146:18 178:18; 184:22; 195:9;
295:4 panel 36:4,13; 37:14; 255:21; 257:13; 264:ll; 199:13,14; 206:7; 207:18;
42:19; 43:4; 251:18 partners 144:17; 154:21 269:1,6; 274:18; 2761,
outcome 17:18; 185:18; 237~2; 249~25; 250:8,9,
panels 57:15; X53:16,20 oartnership 28:8; 11; 278~6; 279~20; 287:2;
234:21 10; 253:l; 254:23; 265:24;
‘46:13,23; 181:25 ?89:5,12,18; 290:8;
outcomes 1611; 23:l; Baper 72:ll; 188:23; !87:23
!94:14 Iarts 200:24 !91:17; 293:10,18;
69:15; 235:8 rersuasive 130:9
bassage 186:8; 187: 1 !94:12; 295:14
outgrowth 146:23 Baradigms 188:14,17; Bertains 234:5
!47:24 bassed 292:5 ,eople’s 46:1,13
outline 49:7; 221:12; Bertinent 211:14
larallel 15:21;72:17; bast 31:l; 49:4; 54:14; ,eople-by 278:9
227:7 rerturbation 52:lO;
!33:7 29:13; 132:24; 212:4; ,er 51:13; 62:6,6;
outlined 77:16; 289:8 ;4:11; 140:2; 259:14
larameter 275:8 !15:3; 246~2; 27O:l; 296:6 102:16; 156:25; 172:12,
outlines 201:19 13; 199:14; 246:6 ierturbs 52:ll
larameters 52:18,19 lath 196:15; 228:4
outlining 240:20 ierceived 201:13 ieruse 290:8
Bare 109:3 bathogenesis 143:24;
output 17:9 !61:6 iercent 32:18; 43:8; iesticides 195:23
outputs 21:19 jarent 31:6; 35~24; 56~6;139:15; 214:19; ‘ET 27:16; 29:15,25;
i6:16; 225:lO mthologic 10:18; 12:2;
outside 193:18; 274:5; 64:18; 261:19 215:12,15,16,17,17; iO:ll;32:3;46:14;47:12,
‘arkinson 5622; 58:13 244: 13; 289:9 !2; 49:9; 50:13; 51:2,9,
284:11,25; 285:17; 288~7 #athological89:25;
aarkinson’s 58:20; aercentages 143:3 11,12,19; 52:l; 54:17;
outstanding 4612 U:2; 157:2; 159:8
;O:ll; 120:21; B24:9 i7:24; 64:9; 65:3; 67:9,20:
over 4~9; 20:13; 5217; ,athologies 91:22 3erception 143:lO
‘arklawn 5:7 ;9:2,11,13,14,22; 70:25;
54:14; 57:23; 58116; 80:6; lathologist 8618 Jerfect 35:4; 52: 18; 74:1,5; 76:7,18; 77:6,17;
89:15; 108:4; 112:24; Iart 4114; 7:6; 25:l; 26:2; 5924; 60:2
L2:25; 105:20; 116:10; lathology 10:14; 18:25; 78~25;94:16; 120:4;
123:23; 126:ll; 127:lO; .9:5; 20:17; 34:12; 82:5,8, oerfectly 105:8,25 125:9,20; 12615; 128:13,
129:3; 146:5; 147:6; 120:18; 133:18,23;
180:17; 183:lo; 185:ll; !O;83:13,20; 85:19; 91:6, perform 252:l 18,22; 129:3; 132:4;
172:20; 178:17; 188:6; I 1.5,18; 114:5; 122:4; t66:12; 223:14; 247:3;
187:12,20; 190:4,12,23; performance 62:8
205:5; 261:3 I.31:24: 133:2,2,15,19, Z48:ll; 256:22; 257:23;
192:3; 193:9; 195:19; performed 207:4;
over-expressed 34:ll 2!O; 134:6; 190:12; 237:13, 258:10,19,23; 259:8;
196:5,13; 199:17; 200:14; 217:23; 220:18
over-expresses 36:l 202:24; 225:15; 231:17; 2!O, 21; 261:3,4; 268:ll 262:18; 265:19
perfused 108:20; 111:20
over-the-counter 236:7; 237: 1; 243:6,22; I:iathophysiologic Detri 54:5
perhaps 18:10,11; 20:8;
205:19 245124; 246~14; 259:5; I171:8; 175:22 Pfizer 6:7
21:6; 27:12; 30:12; 32:18;
overall 46:ll; 125:3; 273~8;275:13; 283:8; I ,aths 278: 10 jO:4,17; 51:18; 52:14; IPh.D 7~2; 27:18; 48~4;
163:20 290:5 I lathways 14:14; 19:18; 65:lO; 67:13,15;68:18; 79~20;92:23; 107:5;
overlap 223:18 Imartial 59:13 1157:3 69:16; 75:4; 124:24; 13616; 155:25; 184:19
overlaying 235:20 Ipartially 197:18 - I
aatient 40:15; 164:21; / 127:13; 130:2; 133:2; 1 IPharmTox 243:15;

ought - Pharm-Tox (22) mn-u-scripti Miller Reporting Company (202) 546-6666


Nonclinical Studies Subcommittee of the Hearing
Advisorv Committee for Pharmaceutical Science December l&l999
-
285:7 Phillips 126:9,10 planning 18:14 portion 202:lO; 212:9; power 81:3; 264:12
Pharmaceutical 4:5; phonetic 107:4 plans 158:lO; 159:15; 218:15 powerful 51:25; 52:8;
6:11,16,20; 7:6,9,24; phosphatase B9:21 188:7; 190:4; 194:ll; portions 131:12 8O:ll; 84:13; 85:2; 104:8;
8:24; 23:19; 26:18; 28:9; phosphor 53:22; 54~4 211:18; 281:19 posed 82~7; 23616 132:ll; 256:17; 262:23;
31:7;40:12; 52:15; 54:ll; plant 282:23 position 67:l; 178:5; 265:8; 268:3
photocarcinogen 149:6,
71:4; 116:17; 117:l; plasma 18:9; 33:6,15; 277:8 powers 262:19
17
121:5; 122:9; 127:23; 34:15;40:18,20,24;41:2,’ positions 65~7; 67:l; practical 140:18,19;
132:5; 149:3; 179:21; photocarcinogenic
145:3 3;61:24; 171:9,12,13 237:18 141:lO; 144:8; 153:18
182:9; 196:18; 203:12;
photocarcinogenicity plate 53:23 positive 38~11; 69:12; practice 16:5,9; 19:20;
251:18; 270:15; 275:24;
144:23; 149:3; 198: 14; platelets 41:24,25,25 151:lO 93:14; 119:22; 185:ll;
278:5; 284:21
228~16; 23620; 255:9 plates 54:4 positivii 65:16 187:20; 189:2
pharmaceuticals 137:3;
PhRMA 68; 22:5; 284:21 platforms 154:4 Positron 27:17; 28:3,20, practices 73:25; 90:24;
142:17; 162:25; 265:25
25; 30:24; 31:2,20; 34:7; 185:l; 213:17
pharmacodynamic physical 103:8; 213:9 play 8:7,13; 13:22; 29:2;
111:24; 12714; 210:13 35:15,18; 3615; 468; 48:3; pragmatic 12615
31:lo; 39:2; 78~4; 138~2; physicians 30~11; 70:16
49:20; 51:15; 53:24,25; pre 193:23
162:7; 1862; 191:8 physicist 80~24; 97:17; played 114:9; 117~7; I666
pharmacodynamics 102:lO; 104:22 143:l pre-administration 57:9
physicist’s 257:16 player 24:14 Ipossibilities ll7:17
pre-IND 129:21; 196:4;
31:4,14,23; 32:l; 34:4
playing 132:lO Ipossibility 52:7; 53:21; 211:17; 281:18
pharmacokinetic 3l:lO; physicists 30~9 t62:14; 70:6; 108:19:
78~4; 190:23 physics 29:16,21; 51:15; plays 16:6 113:23; 117:4; 23j:iO; preceded 49:17
pharmacokinetics 31:3, 53:25; 70:18; 98:4; 99:18; pleasure 102:20 264~25 precedents 35:14
13,23; 32:l; 33:18; 40~18; 102:5,5,7; 121:17 plethora 74:24; 83:5 precise 161:19; 278:7;
Ipossible 51:14,23;
190~20; 225:14 physiologic 99:10,23; plot 43:3 55:11,21; 56:8; 57:19,25; 285:6
pharmacologic 44:5,14; 100:3,5 plug 127:16 58:1,5; 59:3; 64:2; 65:7; precisely 18O:l; 265:2;
164:23; 171:4; 172:8; physiological 13:22 plus 69:13
I67:9; 70: 19; 74: 17,19; 279:ll; 292:17
173:2,22; 225:17,24 physiologist 99: 14 77:11; 113:7,14; 114:22, precision 154:5
pocket 99:4 23; 126:15,16; 160:8;
pharmacological physiology 50:18; 97:19; point 27:lO; 47:23; 61:lO; Preclinical6:15; 38:21;
140:12; 167~16; 168:20; 99:17; 107:24 164:16; 16619; 169:19;
62:3,5; 63: 18; 67~7; 68~9; 201:20; 208:21; 222:22; 39:8; 41:14; 62~24; 67:lO;
169:4; 170:24 pick 30:20; 40:5; 88:24; 71:22; 73:4; 75:19; 76:1, 233:5; 239:14; 2468; 82:15;93:10,13; 115:9;
pharmacologically 143:4; 232:18; 247~24; 10;86:16;88:3,20;89:17; 281:20 116:19; 119:2; 143:16;
192:14 250:17 118~24; 120:23; 126:21; 182:14; 184:13; 229:22;
picked 9:15; 48:19; 96:s; 135:l; 140:16; 142:10,12, Ipossibly 34:7; .61:23; 232:6; 235:9; 259:2;
pharmacologist 49:3; 211:21; 262:2
147:16,17; 244~8 17,21,22; 144:21; 154:4; 269:24; 27O:ll; 275:21;
5O:ll; 53:2; 67:8; 7O:l;
picks 39:10,11 155:12; 179:24; 188:lO; Ipost 174:15 279: 17
129:14
picture 31:17; 43:l; 86:2, 190:15; 194:12; 195:2; Ipostdose 55:4 preclinically 25:25;
pharmacologists 30:13;
3;94:21; 128:6; 260:22 201:21; 204:9; 207:5; Iposter 151:6 38:12,24; 152:13
291:6
208: 1; 209:7; 220: 10; Ipostmortem 56:23 preclude 4:14
Pharmacology 27:21; piece 293: 19 221:3,11; 222:24; 224:lO;
49:lO; 53:ll; 54:17,18; pieces 130:18 coostsynaptic 54:23; Dredefined 278:18
225:5,9; 226: 17; 229~20; Gi7:16,25; 63:s; 64:l wedict 138:17; 149:3;
64:10;79:16; 119:12; pig 100:7; 101:22; 103:20 230:19;231:24; 232:12;
165:11,20; 168:7; 169:25;
pilot 282:23 236: 12; 237:lO; 238: 11; Fpotency 165:13,17; 162:19; 164:19; 232:6,8,
170:5; 173:9; 176:19; 2!06:6; 214:15 14; 245:12,15; 247:10,14;
pilots 252:15 242:l; 248:6; 249:6;
187:5; 188~13; 189:4; F,otential4:20; 9:25; 249:2
pipeline 250:2 252:20; 253:19; 254:8;
191:9; 2OO:ll; 201:1,6, 255~22; 257:9; 261:8; I.1:20; 12:10,12; 13:14; wedictable 175:13
24; 272: 10 pitopride 57:23 265:lO; 269:lO; 271:12; I.4:6; 19:5; 20:7; 25:12,13; xedicted 69:17; 259:8
pharmacotoxicologic pivotal 44:20; 207:7,8 285:17; 288:18; 289:3; 2!9:24;3&11;39:6;47:10; wedicting 85:13; 139:8;
172: 1 pixel 94:21; 115:19 295:22 4i9:13; 54:17;60:3; 64:6; 176:ll; 232:1,2; 249:15;
Phase 40:7; 50:8; 53:4,9, ci5:3; 67:18,20; 71:16; 252:23; 256:13
PK 31:18; 32:8,11; 34:l; Dointed 25:23; 27:l;
7‘9:5,25; 80:3; 81:25;
15; 67:12,16,17; 68:11, 192:4 77~24; 108:4; 131:6; prediction 125:5;
l&16,16; 70:2; 129:22; t )2:24,24; 83:7,17; 84:17,
PK/PD 31:lO; 286:22 133:8; 141:9; 198:6; 253:6 253~20; 267:16
136:12; 138:21; 154:6,15; I18;92:7; 120~25; 131:5;
place 19:22; 41:22; 77:4; Doints 134:ll; 147:13; I133:24; 139:17; 142:5; predictions 253:22
186: 15; 200:7,9,9,9,9; 148~4; 164:6; 189:9;
201:12,18;204:22; 205:l; 122:l; 127:lO; 155:9; I144:15; 145:3; 148:6,24; predictive 92:3; 149:4;
232~2; 242:17; 255:5; 190~15; 208:5 I163:lo; 179:5; 180:2,13, 162:14; 235:6; 236:7,9;
206:12,13,15,15,16;
207:6; 212:5; 213:18; 296:19 polarizer 101:17 I19; 183:18; 184:9; 198111; 239:23; 240:4; 248:21;
I 259:19
2167; 218:24,25; 219:1, placebo 218:3,6 policy 141:2,3; 185:17; 1!10:3; 211:8,13; 212:l;
I
6,6,11; 220:10,11,11, placed 117:9; 143~5 276:14; 283:18 ‘ !20:18; 222:7; 223:24; predictivity 22:25;
I
19; 270:23; 271:l; 272~6, polymorphism 137:8 1!29:11; 233: 11; 237: 14; 148:14; 154:lO; 240:14,
places 34:25;41:23; I
7,10,13; 274:21,22; 1?51:10; 252:25;254:1; 17; 247:16; 252:17
42:16,17; 213:8; 267~25; pool 30:21; 12225;
275:10,11,11 123:2; 127:23 255:11,15; 256:8,16; predictor 132:18; 255:9
271:18
258:7; 259:3; 266:7; predominantly 183:ll
phase-to 274:ll plague 176:9 pooling 122:24 167~7;278: 16; 282:18;
phase-l 273:20 plan 24:8;48:14;72:16; poor 151:1,7; 191:24 288:4,10 prefer 196:6
phases 53:1,9; 142:18; 90:3; 111:6; 19O:ll; poorly 191:3; 21O:lO preliminary 28:16
221:12; 275:9; 296:17 Iaotentially 42:4; 86:8;
207:3 population 122:15; ‘>2:2; 131:8; 141:25; preload 175:3,14
phenomena 126:22; plane 82:17,19;83:1,2, 137:9; 172:23; 17621; 145:5; 149:13,22; 154:22; preoccupied 167:3;
169:18 3; 84:8; 95:2; 109:6 232:17 L78:23; 238:20; 255:3; 173:ll
phenomenon 90~12 planes 87:7 populations 92:4,6; 266:22 preparation 89:14;
phenotyping 110:4 planned 71:7; 201:5 143:2; 176:18 Ipotentials 266:9 114:17
-
Miller Reporting Company (202) 546-6666 Min-U-Scrip@ (23) Pharmaceutical - preparation
Hearing Nonclinical Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science
-
prepare 125:24 prioritization 243:24 processes 9:2,11; promoted 101:2 arovides 25:15; 29:22;
prepared 24:22; 41:14 prioritize 153:13 12:13; 13:23; 17:l; 35:10; promoting 31:13; 33:4 )2:5;126:7
priority 221:25; 222:2; 157:2; 203:s proof 38:15,15; 138:12, aroviding 8:12; 53:4;
prescription 205:18
223:6;247:4 produce 17~13 16; 177:2; lSl:lO,ll 33:18;240:18
prescriptive 280:6
privilege 9621 produced 174:lO proof-of-concept Jroximal 165:3
presence 33:lO
produces 174:2 191:22 Droximate 249:12;
present 4~20; 8624; pro 174:19
product 4:25; 120:13; proper 233:2 25O:lO
88:14;157:11;158:4; proactive 21:6
176:9; 189:15; 190:25; Droximity 252:12
173:6;233:5 probabihhy 43:22 properly 13:25
205:9;206:9,24;207:14; PTSM 65:21
presentation 14:l; probably 22:16; 34:23; properties 104:2; 113:12
208:14,18,19,23; 209:3, Dublic 21:13;22:18;23:9,
28:19; 48:1, lo; 49:7; 9625; 110:12; 114:19; 8,11,13; 21O:i, 21;211:7; property 83:22;103:8;
18; 136:5,6,7;141:2,3;
59:lO; 94:12; 131:25; 117:1,23; 122:3; 123:23; 214:6,23; 216:11,13,20, 233:12,16 159:10,11; 177:14; 219:2;
161:7; 217:4; 224:17; 124:12; 126:1,12,19; 22,23,25;217:6,7,10, proposal 148:10;155:10; 251:25; 295:17; 296~10
225:12; 227:6,23; 257:4; 137:15; 139:14; 14&l; 13,16,16;220:3;226:20; 188:20;224:5;228:12; Dublication 55:3
279:21; 283:23; 287:9,13 148:16; 179:l; 191:4; 280:4 243:3;253:16;261:15,16;
196:13; 221:lo; 225:23; Dublications 69:5
presentation-you product’s 191:16 263:23;293:3
260:20 229:21; 240: 1; 242:6; lublicly 157~7
production 120:12 proposals 155:6;
251:17; 258:2; 260:13; 227:22;228:6;272:18; Dublish 74:15
presentations 24:9; productive 4:7
262:6;264:19;267:10; Dublished 35:22;41:18,
27:25;144:12;204:12; 291:25;294:3
274:4;285:5,16,17,21; productivity 245:ll 20;95:24;113:9;116:10;
284:16 286:17;288:5 propose 72:16;90:4;
products 5:1,8,17; 188:20;189:23;219:1
presented 23:18; 144:12; 211:lO; 223:16;
probe 29:12,15; 36:6,21; 28121; 29:3; 141:25; pull 127:17;136:20;
15021; 201:15; 2164; 166:6; 191:14; 199:21,22; 264:7;292:11
37:11;39:16,16;40:9; 153:4;289:12
222:8,9,21;228:15; 42:lO; 44:17; 45:lO; 205:25;208:19;210:9,13; proposed 193:23;
242:8;268:1;281:5; 194:21; 200:3; 210:22; pulled 48:17
46:11,11,25;47:5,13; 215:8;217:24;273:25;
284:5;286:20;294:12; 247:3 274:20 211:22;214:16;242:15; pulls 262:13
295:24 264:4;270:7;272:19; Pulse 80:22; 81:l; 90:9,
probes 15:2; 29:25; professional 21:15;
presented-this 287:ll 285:14 10;91:21,23; 101:lO;
38:22;46:16;73:9;74:1 78:24;290:1;291:14
presenting SO:2 proprietary 71:12,13; 104:l
probing 36:ll Professor 6: 19
160:4 pulses 103:l
presently 161:15 problem 74:12; 84% profile 39:23; 191:5,16;
prostate65:8,11;78:13 pump 33:ll; 36:2,19;
presents 12:12 110:23; 114:1,2; 118:17; 192:16; 220:5
129:6,7; 210:8,17; protect13:7;281:22 37:4,20
preserved 261:lS profii 142:8
228:13; 236:15; 237:3; protein 14:7,11;38:13; pumped 36:22
President 6:13; 22:7; profitable 256:20
239:l; 240~2; 241:7; 152:2,17,21,23; 16617; pumping 33:2
49:4;129:13 profitably 255:16 228:10;247:2
243:17; 254:18; 257:8; pumps 32:25; 36:2
press 39:5 26O:lO; 276:24; 282:2; program 35:4, G; 41: 15; protein-based 246~24
pressure 96:12; lOO:l, 1; 72:18,21;79:12,14; purchased 214:25
28319 proteins 13:23; 14:3,5;
175:4,12 90:19; 91:8,8; 108:lO; pure 214:19;215:10,11,
problematic 85:5 15:24; 32:17; 141:16,24; 16
presumably 38:7; 236:2 136:12;183:19;202:22;
problems 102:24; 121:6; 142:2; 15018; 152:8,10,
224:15;291:17 purely 77:12
pretty 19:17; 24:7; 29:16; 129:9; 132:5; 208:14; 11,19; 153:6; 157~1;
30:5; 77:19; 112:21; programs 29:19; 32:21; 160:10;167:15,22 purity206:6;214:15
211:21;213:23;232:5;
119:5;122:10;126:17; 184:6; 221:23; 238:18; purple 42:24
237:12;238:7,25;239:10; proteomic 18:22;
136:4;200:20;241:24; 27O:ll
256:13;263:4 15623; 158:2; 160:22; purposely 295:20
253:17;259:16;271:19, progress 21:25; 27:ll; t61:24; 165:3; 229:7; ,urposes 51:ll; 162:6
procedure 132:2; 258:7;
21,22;276:22,24;277:3; 68:2;92:13;237:5;246:4 !36:18
268:12; 279: 13; 286:9 Bursue 222:14,18;
293:7;296:4 progressed229:20 Droteomics 8:24; 15:21
procedures 69:3; !36:23,23;252:3;262:9;
prevent 139:4,11; 155:l 214:13; 215:4,9; 216:l; progression 139:4,21, 152:16;178:20;228:8; 284:8;289:6;290:12;
prevented 142:25 217:19; 218:5; 223:19; 22 254:22 291:2
previous 5:16; 8:4; 235:21 prohibitive 138:25; proteosomes 13:21 Dursued 2621
114:4;115:4;261:18 proceed 11:8; 177:14; 139:lO protocol 56:9; 186:4; aursuing 221:22
previously 50:23; 83:8; 252:1;260:9 project 28:2; 32:16; 202:5;216:7;232:25; Dursuit 234:6
113:5; 114:24; 221:lO; PROCEEDINGS 4:1; 127:6; 131:ll; 156:3,11, 239:25;273:10,10
21;157:5,8;158:6,21; ourview 286~5; 289:15
262:1;273:9 135:3; 1361 protocols 80:23;123:3;
160:5; 161:4,5;164:1; push 5:21; 262112; 2966
primarily 25:9; 73:lO; proceeds 38: 14 130:23; 131:l; 196:l;
81:13;116:20;186:6; 224:7,9,14;244:4; 201:18,19; 278:18 pushed 3322; 116:l
process 9:8; 12:9,12; 245:11;246:2;279:5;
193:20;200:8;223:21 proton 8O:lS; 100:18; pushing 74:2
16:15; 19:l; 21:12; 25:3; 285:12;294:23
primary 42:5; 165:ll; 26:ll; 30:5; 33:5,9; 59:22; 105:9,25 put19:13,19;39:5;
189:21; 281:21 projected 151:3 48:19;67:1;99:3,21;
79:6,25;92:1,14;93:14; protons 102:13
primate 52:25; 57:1,4,6; 96:5;126:20;130:2; projections 269:5 103:20; 112:l; 126:15;
prototype 292: 13 128:5;129:13;146:7;
58:9 132:9;159:14;160:16,19; projects 21:24;30:20;
prototypic 159:7 159:12;165:6;178:18;
Princeton 100:15,21 164:18;176:6;177:7; 252:15;253:6,11,13;
183:4;185:19;1187:25; 279~4 proven 41:6;58:18 195:16;203:8;206:11;
principle 38:16; 188:25; provide7:19; 13:15; 220:8,9;227:13;228:6;
189:l; 221:19 188:4;206:14;214:2,8; prolactin 170:1,10
217:3;218:5;219:2,23, 23:7;84:24;91:12;92:2,3; 246:7;248:4;251:8;
principles 73:25; 74:3; proliferation 149:24,25
23;220:15;222:21,22; 162:11;178:1;180:25; 253:15;260:15;261:9;
279:16;280:7 prolific 32:22 267:22;268:12;280:1; 273:16;281:12;293:9,13;
223:1;224:13;249:20;
prior 60:16; 268:22 253:8;261:5;271:2; prolongation 234:19 293:2 295:3
priori 222:16 273:9;283:12;290:18; promises 164:2 provided 62:23; 259:19; putting 38:3,8; 70:23;
priorities 222:12; 246:17 295:16 prOIIIiSing 147:4;152:3 1 277:8;283:23 98:11;103:21;108:12;
- -
prepare - putting (24) Min-U-Script@ Miller Reporting Company (202) 546-6666
Non&nica.l Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999
-
208:12;241:8; 248:19; IRags 98:15,16,22,22 567; 59:17; 64:6,9; 68~9; recognize 81:s; 133:20; I :223:8; 224:7; 235:5
257:14,15 Iraise 221:14; 233:12 70:19;78:1,2;80:3,14;
81:2;85:12,20; 86~4;
169:5; 186:14; 198:25
recognized 158:16
II Regarding 59:ll
Iraising 185:4
87:18;88:5;93:13;95:20;
I 1regards 49:15; 51:7;
Q Irange 7:25; 12:23; 14:17;
15:10; 54:3; 55:16; 57:24;
9620; 100:15; 102:6,20;
105:16; 106:15; 107:18;
recommend 21:4; 22:23;
210:5,16; 220:14; 229:25;
165:ll
Iregion 36:16,20; 87:4,
76:6; 95:3; 14020; 235:23 16,23,25; 88~9
QA 202:6; 284:l 11013; 114:1; 115:16; recommendation 208:5;
148~19; 172:5; 193:6; 118~18; 119:3; 120:15; regional 107:22
QT 234: 18 225:17 2207; 229:14; 2365;
127~19; 130:19; 131:7,11, regions 36:15;61:20;
qualifications 182:24 Iranges 171:3; 190:9; 268:9; 270:3; 283:20; 35:18; 89:lS
21; 134:9,18; 13623; 289:11,20; 290:6; 294:s
qualified 5~11 225:18 142:ll; 145:25; 146:16, Register 21:13; 145:14;
qualify 17625 Iranging 53:5; 173:2 20,21,25; 147:13; 15O:lO; recommendations 8:2;
i189:17; 280:12
154:14; 179:lo; 18O:lo; 17:4; 21:7; 13613; 222:9;
qualitatively 66:24 Irapid 92:2 Iregistration 183:3
223:6,17,20,25; 227:21;
quality 45:14; 5618; Irapidly 8~19; 24:24; 37:6; 181:6; 182:9; 183:13;
228:25; 229:16; 2302; Ipegressing 138:lO
163:2; 181:l; 204:14; 103:12; 137:17;296:10 184324; 185:18; 186:9;
235:15,25; 2603; 277:2; I,egular 274:25; 275:l
206~5; 214:15; 216:16; 189:lo; 190:7; 195:14;
Irat 36:16; 37:1,2,14,15; 283:24; 284:s; 288:16; Ieegulated 4:18; 15:4;
218~6; 220:3 ‘j7:7; 86:1,12; 100:19; 199:s; 200~10; 201:18;
289:23; 290:7,11,16; I18:s. 12; 2617; 178:13
105:10; 106:14; 117:21, 202:3; 204:7,20; 207:7;
quantifiable 51:12 291~2; 293~24; 294~4;
211:14;212:11;215:11; I*egulation 7:21; 23:5;
quantitate 96:14 22; 127:8,9,9; 150:5,7, 295:3
216:s; 22O:ll; 222:l; I125:6; 28610
11,12; 151:lO; 169:24; recommended 215:21
quantitating 95:25 223:4; 224:13; 225:5,15; IRegulations 199:lS;
J172:4; 175:5; 230:15; recommending 8:8;
quantitation 81:6; 84:14; 227:14; 228~20; 234:1,4; A200:23; 201:17; 205:22;
242~25 229:19; 255:21
92:15 236:5; 237:2,4; 238:14, 1207:20; 218:12,15,18;
Irate 76:17; 100:3; 163:6,
quantitative 81:9; 96:3, 14; 239:22; 240:4; 241:21; reconstruct 75:l
7; 2562; 268~19; 278:21 278:15; 284:13,14
4; 21619 242:20,22,24; 24623; reconstruction 74:13,
Irates 96: 10 249:lO; 251:l; 255:17; Iregulators 26:4; 139:6;
quantitatively 17:21 22; 75~2
Irather 4:25; 37:l; 52:4; 256:1,18; 258:11,18; 1144:5; 178:13; 277:13
quarter 219:4 record 4:14; 5:13; 194:6;
t S7:16,23; 78~4; 124:1,25; 259:25; 263:24; 264:16; I*egulatory 14:21; 16:4,
213:22; 223:ll <>,19,23,25; 17:1,4,6,10;
quick 173:24; 256:9; 1131:13; 15625; 162:20; 268:13; 272~22; 279:13;
288~2 1163:2; 172:lo; 173:20; 281:3; 283:7; 285:25; records 282:24 12716;28:19; 29:2; 5O:l;
quicker 181:9 178:l; 241:21; 287:20; 28619; 287~25; 29218 recovery 44: 10; 187: 10; 7212; 124:14; 125:12;
288~23 realm 50:16; 196:14; 190:16 1143:7; 144:14; 155:2,13;
quickly 48:14; 52:4;
64:20,23; 202:13; 258:15; Ipatio 172:6; 173:7 250:6 recreate 233:3 157:lO; 178:7; 182:l;
262:16; 288:ll red 5:20; 15:6; 34:19; 184:22; 185:17; 195%;
Irationale 133:18; 272:ll rearranged lo:25
196:21; 199:13; 200:2;
quite 37:20; 47:19;49:18;
51~24; 5218; 55~24; 567;
Irationalizing
Iratios 173:ll
162:lO reason 39:9; 82:6; 88:25;
115: 17; 202:9; 209:6;
42:22; 43:7
redefining 158:2; 288~7 II 201:8; 203:l; 238~2;
270:9; 271:l; 279:7;
61:23; 62:8; 64:22,23; 210:5,15; 211:12; 218:ll; redox 14:12
Irats 35:23; 38:12, 14; 286~15
6817,s; 72:lO; 78:lO; 87:5; 242~8; 272~4; 283~9 reduce 64:14; 92:ll;
t 35:4; 9610; 99:7; 174:s; Ireinterpreting 288:7
88:11,19,20; 96:13; 97:9; reasonable 194:5; 103:13,14,16; 154:21;
239~6; 256~22 reinvent 287:7
101:15; 110:12; 113:7; 195:22; 201:3; 216:13 178:lO
Ireach 47:7
114:22,23; 120:9; 124:l; reduced 171:ll reiterate 177:25; 221:15;
Ireached 80:14
reasons 42:l; 143:16;
133:l; 151:13; 155:17,18; 145:15; 207:24; 216:25; 232:12
160:2,8; 167:7,7; 212:5, Ireactions 11:24; 90:17; reducing 163:5; 181:5
221:19; 228:15 relate l&11,13; 17:17;
17; 214:6,24; 224:9; 247~14; 282~2 reduction 171:6,7,10 148:20,22; 165:5; 210:21
228~24; 275~22; 283~19; reassure 271:24 redundancy 161:7
Ireactive 14:13 Irelated 7:s; 9:3; 15: 12;
296: 1 reassuring 272:l reemphasize 178:4
Iread 59: 10; 240: 15; 28~2;32:19; 46:lO; 61:6;
quote 140:25; 141:7; 258:25; 292:23 recall 62:19; 111:9; reexamine 12:5 ,91:23; 143:24; 167:8;
233:20 258:13 refer 81:1,21; 9O:ll; 171:24; 172:7; 185:14;
Ireadily 141:4,19; 226:23;
quotes 246~7 229:lO; 237:15 receive 82:9,12; 125:24 168:14; 178:20; 239:2 192:14,14,15; 227:25;
Ireading 72:12
received l93:4 reference 69:2; 15625; 233:16; 273:15; 275:7;
284:2; 286: 18
R Ireading-what 292:24 receivers 113:19
recent 28~3; 58:3; 80:6;
166:3; 168:24; 212:19;
230:19 relates 35:15; 211:2
Iready 52:6; 221:4; 236:5
102:23; 104:ll; 111:18 references 120:21 relation 164:5; 168:6;
rabbit 65:s; 151:ll Ireagents 91:14
recently 55:20;73:22; referred 102:24; 142:l; 173:19
raclopride 57:16; 63:21; Ireal 26:13; 31:25; 34:lS;
101:19; 146:12; 170:21; relationship 16110;
64:2 45:20; 95:22; 112:21;
113:23; 118121; 120:22;
239:21; 271:15
164:25; 174:23; 247:l;
248:25
I’ 100:14; 154:9; 162:3,16
radiation 53:24; 54:2; receptor 35:2,7,9; 45:7; referring 60:9; 115:4 relationships 158:4;
66:6; 69:23 121:15; 124:lO; 127:21;
145:lO; 153:18; 225:23; 51:4; 55:9; 57:16; 64:l; refers 58:12 161:19; 168:10,13;
radio 102:25 23715; 2569; 26412; 65:16;74:11; 181:13; 169:21; 171:18; 172:22
refine 12:2; 247:19
radioactive 258:lO 266:20; 275:23; 280:16 191:25 relative 97:7; 172:3;
reflect 139:24; 170:24;
radioactivity 257:24; realization 126:12 receptor-based 35:4 245: 10
181:22; 206:s; 24916
258:s receptor-positive 65:13, relatively 11:ll; 25:18;
realize 15: 17; 50:s; reflected 161:14
radioautography 179:s; 180:3; 239:9; 14 44:6; 49:21; 51:19; 55:19,
lll:lO, 13 reflecting 175:7; 249:16 23;64:17;69:11;73:11;
274: 14 receptor/mechanism
radioisotope 265:s based 49~23 reflection 60:2; 246:14 105:23; 132:12; 173:2;
really 8:4; 9:4; 10:24; l&1:4; 201:22; 255:15;
radiologists 81:s; Receptors 34:23,24,25; reflections 16l:lO
11:5; 13:2;22:11; 25:14, 256:3
121:25 20; 26:2,7; 31:22; 32:2,5, 54:24,25; 55:6; 57:25; refreshing 160:2
6; 38:19; 40:6,19; 41:5,6, 62:23; 63:s; 192:3 regard 4:13;48:14; relaxation 114:25
Radiology 98:6; 122:2,
release 147: 10
17,18,21; 126:6,25 14; 50:15; 51:24; 52:8; recessed l35:4 -i 70:21; 120:4; 188116;

Miller Reporting Company (202) 546-6666 Min-U-Script@ (25) QA - release


Hearing Nonclinical Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science

released 10:8; 142:2; represented 43:15 response 10:19; 15:lO; reviews 125:19 routinely 8:l; 89:23;
i50:18; 174:19 representing 157:3 17x20; 19:2; 43:20; 44:18; revise 287:20 113:15; 128:4
releases 39:5 represents 87~19; 84:21; 88:23,25; 13610; revised 218:lS rubidium 1Ol:l
relevance 52:18; 64:22; 107:lO; 242:17 137:ll; 139:25; 140:3; Rudin 93:23; 95:12;
revising 219:3
67~24; 143:5; 145:4; 149:5,10; 150:17; 154:7, 11622
reproducibility 148:19 10; 157:16; 159:6; 162:19; revisiting 277: 15
163:16; 168:24; 175:21; reproducible 1616 REYNOLDS 6:6,6; rule 200:21
M&:23; 167:1,21; 16&l,
176:ll; 231:lo; 234:1,21 24:12,13,19,20;73:23; ruled 245:18
reproductive 197:2 9,11,12,17; 169:4,21,
relevant 31:l; 53:5; 25; 170:13; 171:14,18,19, 75:21; 78~23; 93:4,8; rules 12819; 223:12;
59:21;60:1;89:16;91:12; request 5:6; 218:14
21; 172:8,8,15; 173:1,10; 115:4; 125:s; 177:16,20, 295:19
93:13; 98:5; 122:12; requests 1367; 193:5
175:10,13,15; 199:2; 21; 184:16; 233:19; 252:6; rumor 288:l
1308; 141:21; 143:9,18; require 124:19; 17732; 225:7,12,16; 227:25; 263:lo; 275:13; 277:lS;
145:2,7; 149:8; 154:25; 179: 10,19; 194:7; 199:s; 279: 15; 280:16; 282:7; run 29:7; 188:12; 232:5
234:20; 246: 19,20;
155:15; 160:25; 191:13; 202:18; 205:25; 207:lO; 259:25; 263:13; 272:25 285:3; 288:2 running 35x$78:15;
19619; 198:s; 200:14; 2206; 282: 17 RF 113:19 20617; 224:15
Iresponses 10:15,16;
234:4; 237:21; 241:14; required 7O:lO; 72:19; 11:6,21,21; 18:21; 19:8; ribbon 129:18
242:14
relevantly 169:16
97:lo; 124:20; 177:3;
179:22; 277:20
20:14; 25:22; 8021; 90:s;
140:10,12; 142:14; 158:3;
rich 142:5 S
Richard 48:4; 73:s
reliable 174:20 requirement 2620; 159:25; 162:7; 167:16;
166:16; 23612; 240:6 168:20; 172:l; 229:4; rid 14:5; 3624 safe 160:23; 178:14;
reliably 138:16,17; 186:8,25; 189:l; 201:3;
259:13 requirements 234:5; 245:16 right 19:18; 301; 33:16;
39~20;40:10,17; 43:4; 205:s; 206:24; 208:1,8,
reluctance 132:24 27O:lO; 271:20; 28614 Iresponsible 25:l
18:19; 49:25; 113:8,20; 11,17; 250:15,18; 287:23,
rely 159:23; 234:s; 255:7 requires 68~5; 179:14; Iresponsive 170:5 25
114:2,19; 116~15; 118:5,
remain 72:2; 260:s 205:19,20; 229:17 Iresponsiveness 278~22 $119.5.12615.127.3 safety 9:16,18,24;
requiring 67:17; 108:15 Irest 37:22; 112:l; 13O:ll; 1;; 12&i, 5; ;38:11; ’ ’ 10:25; 11:14,18; 17:15;
remaining 220:25
remark 15725 requisite 180:5 262:13 177:15; 188:ll; 229:13; 25:3,25; 26:2,5,9,10,16,
Research 4:19; 64; Irestate 22:21; 290:25 239:11,16; 25O:lS; 19,24,24; 7621; 81:16;
remarkable 178:22
27:23; 30:23; 35:22; Irestrictions 17:14 251:21; 253:3; 282:6; 137:2,24; 139:2,8,13,20;
remarks 24:3,22; 164:5 70:17;71:16;79:16,17; 292:22; 296:5 145:15; 146:22; 151:1,7,
remember 155:4; 258:9; Irestrictive 25:6
101:18; 138:2; 141:2; pighthand 44:3; 57:15; 12; 154:21; 162:lS;
266:l 144:13; 154:20; 155:6,10; Iresult 29:19; 56:21; 169:23; 176:8,25; 181:2;
I67:16; 12O:ll; 139:l;
166:ll
reminded 92:24; 157:25 199:5; 203:24; 204:7; rigorous 13:13; 152:5 184:18; 188:13; 189:3;
224:12; 243:15,23; 163:20; 185:6; 189:16; 191:8,9; 2OO:ll; 201:21;
reminds 223:lO ring 5:20
246:13; 269:2; 293:1,16, 220:5 202:3; 206:s; 207:12,23;
remiss 281:25 risk 27:3; 38:s; 64:ll;
20 Iresulted 57:13; 178:22; 210:9; 211:25; 212:1,3,
remit 285:lS; 288:s 194:24 138:25; 149:3; 156~24; 12; 213:15; 216:s; 218:7;
researchers 60:17;
remodeling 246:9 Iresulting 166:7 160:19; 161:6; 162:6,11, 219:7,8,8,12,16,20;
70:17
removal 142:22 16; 163:13,15,15,18,20; 220:12,14,18; 254:lO;
remove 262:22
removed 142:24; 216:23
reservation
reserve 226: 13
reservoir 75:18
160:4 Iresults 41:13;64:15,23;
,67:5;69:15;72:5;74:18;
80:14; 95:22; 134:5;
I:
165:14,16; 1662; 168:22;
170:16,18; 172:18; 211:8,
14; 235:6,13,14,17;
255:l; 257:11,12; 259:11,
22; 273:13; 279:17; 280:4;
198~24 282:18; 283:12
renal 145:24; 173:3 reside 169: 13 236:9; 259:3,6; 260:5;
resumed 135:4 sagittal87:9
rendered 109: 18 resist 7611 265:21,21
resummarize 288:17 sake 128:13
repair 13:7,10 risks 18621; 211:11,12
resistance 32:24; 33:4 sales 80:s
repeat 43:4; 52:1,7; retain 178:12 RMS 102:14
resolution 51:16; 55:23; saliva 166:24
64:13; 164:6; 200:4; retained 65:2?., 22; 67:3 RNA 141:16
86:5,7;87:5;91:11;94:14, Sally 103:16
278:25 19,20,23; 95: 1,5,7; 97:9, retention 171:9 road 15:15; 211:21;
repeat-dose 200: 17 12,15; 99:7; 1009; 101:6, rethinking 296:s 257:21; 260:12; 291:lO same 10:24; 16:17; 18:3;
repeatable 2622 6; 102:ll; 105:7,15,23; reticulum 249:16 35:lO; 37:2,14,14,18;
Robinson 145:20; 224:6, 39:2; 42:l; 44:13; 53:12,
repeating 187:lO 107:11,13; 108~25; 109:2, retrospectively 41:6 $16
6;110:12,21,22;111:12, 16; 56:5; 57:ll; 62:21;
repertoire 159:9 return 44:12;61:5; robust 162:ll 66:14,14; 67:ll; 71:23,
16,23; 112:4,5; 113:2,16; 175:15
replace 197:19; 238:23 robustness 148:lS 24; 74:15; 76:13; 85:9,10;
114:7,11,13; 115:8,14,
replacement 197:20 14,15,18; 117:4,7,21; returned 6l:l rodent 52:25; 55:18; 87:8,22; 90:12,22; 92:13;
report 202:13; 219:17; 118:l; 128:18,23; 261:l reveal 160: 10 56:4,10; 173:3; 190:8,9 97:7; 105:9; 106:11;
251:18,22; 252~4 revealed 157: 15 rodents 20:16; 132:17, 109:6,9,25; 112:12;
resolve 159:3 113:25; 126:3,7; 128:l;
reported 4:17,20 resolved 16:18 revelation 268:2 17
168:13; 169:11,17,22;
reporting 234:5 reverse 94: 11 Roger 146:3
resonance 50: 14; 52: 13; 172:6,7,9; 175:21; 192:3,
reports 21:20; 202:6,15, 79:19,24; 81:21,22; reversibility 154:ll role 8:7,13; 13:22; 16:6; 22; 193:14; 205:7; 210:24;
17; 203:3; 271:s 92~22; 94:5; 128:15,23; reversible 33:s; 42:4; 23:3; 45:9,13; 96:19; 213:l; 214:9; 216:25;
repository 127:25 129:l; 133:16,21; 168:5 44:1,6; 62:s; 140:22; 143:2; 295:23 225:16; 226:16; 238:7;
represent 6:7,13,16; resources 12:24; 21:l; 164:20; 190:18,19 Room 5:7,25; 98~24; 24O:ll; 249:14; 250:23;
22:lS; 75:17; 258:14 24:l; 76:3,8; 179:22; review 130:7; 143:ll; 102:6; 257:18; 283:3; 259:24; 260:2; 270:2,3;
181:9; 199:5, e; 221:22; 147:25; 150:9; 211:20; 292~20; 293:lO 273:4; 286:lO
representation 22:17;
233:15 244:21; 245:20; 264:19; 212:7; 242:7,16; 271:l rounds 275:2 sample 34:19; 54:6;
representative 6:21; 292~7 reviewed 26:21; 224:4 route 186:4; 191:3,6,24; 64:19; 76:16; 82:19; 89:3
22:6,12 respect 5:1,14 reviewers 72:6; 82:8,12; 200:14; 278:24; 289:l sampled 18:s
representatives 22:4,5; respects 182: 11 83:15; 130:9; 155:14; routes 191:l samples 90:17,22;
157:12; 202~23; 246:3 respond 157: 1; 282:7 212:6,21; 214:7 routine 112:25; 228~21 232:25; 233:2
- -
Non&&~ Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999
sampling 33:6,7 science-based 283:16, seems 30:19; 231:23; session 150:21 shows 20:16; 36:16;
sand 48:18 20; 284~6 260:16; 268:20; 27713 sessions 70:25 63:3; 97:23; 99:9; 102:25;
Sanofi 6:15;47:21; Sciences 4:5; 6:17,20; sees 77: 17 set 7:4; 9:19; 10:3; 12:5; 104:13; 105:15; 192:21;
129:14 7:6; 80:5; 132:6; 251:18 segmentation 92:16 17:3; 23:24; 24:23;41:14; 209:24
Sanofi-Synthelabo 49:3 scientific 7:8,13,20,25; segmenting 96:2 68:23; 105:25; 106:21; sick 132:23
sapiens 42~7 8:6,10,13,15; 16:7,7,23; 109:4; 169:17; 222:20; side 37:10; 39:22; 44:13;
seize 26:s
17~8; 20:23; 21:19; 23:4; 228~2; 233:9; 28712; 57:7; 58:12,13,18;
sat 130~15 select 181:19 125:?2,13; 16612; 171:3;
27:2; 29:ll; 156:22; 292:14; 293:5
satisfactory 29: 12 157:7; 160:5; 163:25; selected 21:17; 160121; 180~3; 182:7
sets 12:l; 24:4; 128:1,3
satisfies 64~9 268:5,7; 270:9; 278: 15; 17618 sidestep 288: 15
setting 7:7; 10~3; 115:8,
satisfying 83:lS; 212:20 279:16; 280:2,24; 285:6, selecting 23:23; 45:3; Siemens 126:8,9
20; 133:16; 155113;
sauce 109:ll; 112:14 13; 286:3,4,6,7; 287:16; 250~21; 272:12 sight 125:3
159:17; 162:2; 188:14;
save 202:lO; 239:5 289:25 selection 45:21,21; 194:18; 238:2; 273:16; signal 63:9; 100119;
saving 200:5 scientifically 16:19; 16&13,16; 162:lo; 163:3; 274:12 101:3; 102:13; 103:5,6,
278:20; 281:6,15 255~6; 275:7 10,12; 104:3,7,23;
savings 163:1,2 setting-to 287:4
scientists 2724; 177~5; selective 61:18 105:16; 111:22; 112:4,13,
saw 80~6; 111:20; 1565; settings 188:25; 229:12
260:20 224:12 selectivity 165:23; 1661 14; 113:22; 114:25;
settle 126:16,18 115:18,20,23,24; 117:lO;
saying 132:3,8; 134:13; scope 65:3; 156:16; Selegeline 42:12,16;
60:9,10,22,24; 61:3 seven 89:6,10 140:1,6,7; 153:24;
13618; 142:23; 144:25; 201:5
self-validation 132:s seven-year 246: 1 164:22; 173:18
164:12,13,13; 184:s; scoring 147:12
sell 109:5; 284:19 seventeen-step 277119 signal-to 56:6
198:17; 221:17; 231:6; screen 67~22; 89:23;
235:20; 239:15; 240~11, semantic 32:7; 45:s Several 93:22; 98:15; signaling 19:3
92:3; 227:6,11; 2368; 111:18; 112:23; 118:s;
11; 243:4; 245:5; 255:7, 256:7; 272:23 semantics 32:2 signalling 9:3; 246:1
12; 25915; 265:12; 266~24; 141:10; 170:21; 208:4;
screening 39:8,10; send 21324: 276:7 signallings 11:25
270:l; 277: 16,24; 279~6; 225:5; 23613; 253:5;
178:21; 183:ll; B85:12; sending 64:lS 261:ll; 265:24; 266:6; 5ignals 19:1,7; 155:3;
280:12; 281:7; 286:7; 211:7,13
192:5,5,10,13,23,25; senior 201:11 276:5; 284:9
287~20; 291:ll; 293:22;
193:5,12,23; 194:10,13, severely 186124; 188:2 significance 163:17
294:6,7 sense 7:17,18; 8:9;
25; 204:19,21; 205:5,6; significant 69:4; 163:ll;
scale 42:21; 9623; 97:l; 226:7,12; 272:3,12,17; 10:15; 95:19; 124:24; SGE’s 295:17
132:l; 138:l; 140:6; 169:6; 175:7; 187:12;
105:15 273:14; 274:7,9,25; SGEs 290~18; 295:12,14
153:24; 155:ll; 217:6; 190: 10
scan 27:16; 468; 47122; 275:5; 280:23 shaking 226:14
225:15; 226:11,21; significantly 248:16;
64:18; 69:3,13; 74:14,21; screens 237~24; 243:6 Shall 224:l; 226:2;
256:19; 261:7; 276125 265:9; 273:6; 279:14
86:3; 89:ll; 92:4; 98:17, 234:16
scribbled 130:16 sensitive 1617; 19:25; silicon 106:ll
24; 109:13; 113:17,24;
se 156:25; 199:14; 2466 20:9,18; 64:17; 72:14; shape 43:20 silver 111:13
117:20; 223:15; 248:ll;
256:22; 258:23; 259:8; search 26123; 83: 17; 83:25; 92:2; 165:15; share 30:19; 41:9; 122:5; similar 55: 15; 66:19;
262:lS 291:23 169:13,14 153:15; 156:7; 161:10;
75:13; 86:17;88:20;
second 34:3; 37:4,15; sensitiiity 77:5; 84:2; 177:ll
scanned 87122; 89~4; LO&l; 123:2; 127:s;
108:24; 109:21,23; 11:9; 53:18; 74:4; 82:18; 108:7; 148:3,13; 154:9; shared 51:10; 159:lO 168:ll; 217:20; 262:10,
110:19 30:7,21;91:8;99:15; 165:13,18; 169:6,9; shed 152:12; 177:22 11; 289:10
scanner 55:20; 85:22; 102:16; 116~5; 121:19; 171:2; 266:18 Sheinin 182:21; 204:13, similarly 121:22; 170:12
99:5; 121:19 131:3; 157:9; 186:7; sensitization 171:7 15; 220~22; 281:l; 283~4 simple40:1;69:11;
243:s; 246:18 sensitizers 170:22 Shields 69:6 >7:13; 126:l; 141:2;
scanners 120:5
Secondary 165:20 sent 221:9; 260:6; 265:3 shift 96:17 170~17; 171:ll; 184:4
scanning 80:22; 95:21;
110:13; 112:9; 133:11,12 Secondly 39: 18; 83: 1; sentinel 170:s Shifting 129:12 simplistic 167:14
Ll5:9 5implistically 168:l
scans 67:5; 89:2,3,6; separate 230:13; 258:24 shine 100:25
91:lO; 111:15 seconds 128:21,25 simply 74:20; 75:5;
separated 120: 15 shoes 93:1
scar 113:13 secreted 18:s; 142:l 37:10; 141:6; 159:13;
separating 77:23 short 4416; 52:1,7; 64:12;
scarce 261:9 secretory 249:20 132:12; 256:3; 274:14; 168~22; 265~7; 278~6
September 23:20
scares 293:4 section 24:10; 79:14; 287~5 simultaneously 66:2;
32:23,23; 83:l; 84:6; sequence 104:l; 152:4, 113:24; 118:8,10; 261:12
scenario 120:22; 167:25; 6 shortage 70:14
35:19; 86:19; 98~4; single 64:17; 67:16; 89:6,
171:25 sequences 80:22; 81:2; shorten 295:1
121:17; 204:24; 206:22 11; 107:8,8; 122:4;
schedule 43:ll 90:9,10; 91:21,23 shortening 111:23
sectioning 87:9 150:24; 151:3; 168~23;
scheduled 136:6; 296:10 sequential 37:6 shorter 66:5,7 ?74:11; 182:15,20;
xctions 82:13,15,16,
scheduling 23:21 !l; 87:2,4,25; 92:ll; 5equentially 37: 11 rhow 58:3; 84:9; 95:3; i83:14; 185:12,22,22;
scheme 227:9 4!60:23,23 series 69:12;92:4; 173:l LOl:4; 102:7; 103:24; !86:14,17,18; 187:5,9,
schizophrenic 64:4 serious 76:25; 282:1 LO5:21; 108:9; 172:13; .5,15,21,21; 188:16;
5iectors 28:10
!15:13; 216:21; 252:10; i92:7,17,20; 194:lS;
Science6:11;7:10,11, 5;ee-loo k 269: 12 serotonergic 62:22 ?63:25; 264: 1
25; 8:14,18,21; 14:20,20; !71:20; 272:16,24;
d;eeing 4516; 98:5; 150:6, serum 141:24; 142:13; showed 116:8,8; 153:3; !73:10,22; 276:5; 277:7
17:2; 19:12; 23:19; 24:2; I 15;232:l; 242:23 147:6,7,10; 148:20;
28:25; 29:4; 31:7; 72:l; 175:9; 205:4; 219:25; single-you 122:24
s;eek 27:13; 252:16 166:24; 167:s !47:15; 25816
80:12;97:20; 118:18; iingle-dose 188:18,20,
I seeking 156110 serve 23:3; 29:l; 248:13 showing 66:15,16;
119:6; 120:19; 121:15; Zl; 189:10,12,14,18,19,
124~2; 125:4; 126:4; Gieem 27:11;64:18; served 7:22; 115:lO; 32:24; 105:23; 150:12; 20,25,25; 190:6,6;
13O:lO; 143:12; 151:19; I198~5;256:6; 260:23; 201:2; 238:16 174:6; 217:16; 265:15 191:12,19,21; 192:7;
155:17; 178:6; 222:7; ; !66:2 service 264:2 shown 40:14; 4412; 193:8,19,20; 194:12,12,
235:5; 256:l; 287:10 seemed 276:23 I !serving 113:4
- 38:25; 108:5; 269:7 15,16; 231:7; 273:20;

Miller Reporting Company (202) 546-6666 Min-U-Script@ (27) sampling - single-dose


Hearing Nonclinical Studies Subcommittee of the
lbecember 14,1999 Advisory Committee for Pharmaceutical Science

274:8,9; 277:9,11,13,14; 87:1,6,12;88:13;89:7; solution 114:21; 129:lO 119~15; 122:6 spin 38:11,12
278:6; 280:13,22; 282:12, 90:1,14; 91:7,19,25; solutions 129:lO specie 165:13; 169:9 spins 104:2,23
31 93:24; 94:3,10; 95:13; solve 237:3; 239:1 species 14:13; 67:24; spirit 28: 18
singular 141:5 96:6,16,24; 97:11,22; some-l 157:18 141:11,22; 148:21; 149:4; split 31:22
sins 166:12 99:12; 100:6,12; 101:7, 150:25; 151:3,5; 153:17;
somebody 117:2; 206: 1; spoken 128:13; 185:3
16,21; 102:4,19; 104:lO, 161:2; 165:15,18,24;
Sistare 20:5; 136:14,16, 212:24; 213:21; 214:25; spongiosum 65:12
18; 105:5,12,19,22,24; 16621; 167:23; 168:13,
17; 155:22; 166~3; 174:3; 231:8,16; 282:1 sponsor 72:lS; 77:3;
176~24; 225~2; 243:17; 107:7,21,25; 108:8,22; 21,24; 169:4,5,22,24;
109:1,8,17,19; 110:2; somehow 34:20; 47:3; 150:4,10; 201:2; 206:11,
246:ll; 248122; 252:ll; 170:17,25; 171:2,20;
13621; 137:4,20,21; 70:16;72:4; 111:9; 119:1, 25; 209:1,18; 210:20;
265:10 172:2,5,6,9,16; 180:21;
139:18; 140:24; 141:s; 6; 231:2; 238:5; 256:4,11; 211:9; 215:l; 217:25;
Sistare’s 161:7; 227:21 186:6,7,8; 187:6,6;
142:6; 143:22; 144:iO; 267:19 285:12
site 33:ll; 40~25; 41:l; 190:s; 191:20; 197:s;
145:12,18; 147:2; 148~9; someone 184:l; 191:25; 2OO:lS; 227:7; 231:12; ,sponsors 39:19; 130:3;
42:6; 54:19; 6l:lo; 71:s; 149:1,14; 150:2,19; 233:20 247~7; 259:22; 260:l; L44:6; 147:25; 155:14;
78: 12; 90:23; 110:9;
151:17; 152:15,24; 153:3, someplace 103:5 274:21; 277:7 207:17; 235:16; 26O:4;
137:7; 138:5,24; 161:20;
8,25; 154:18; 156~3.4; Sometimes 40:18,19; specific 7:lS; 11:21,21; 279:23; 287:15
217:25; 262~20; 265:17
157:14; 1585; 159:19; 138:19,20; 166~25; 12:l; 15:24; 20:s; 21:10, ! fpontaneous 175:5
sites 90:22;91:1; 112:s; 161:13; 162:23; 164:4,6, 194:14; 207:17,18 18; 2615; 28:21;47:10; ! spot 36: 17
165:21; 192:l 8; 1669; 167:2,13,24; somewhat 79:11,12; 48:12; 64:16; 74:21; 45pots 63:17; 152:3; 159:5
sitting 20:24; 37:22; 169:1,20; 170:19; 171:23; 161:21; 262~4; 282:20;
250:5 76:12,12;91:9,21,21; 4spring 150~22
172:24; 173:12,23; 295:4
situation 27~7; 38:6; ?2:10; 962; 125:l;
174:22; 175:8,23; 178:3, ! stab 293: 13
somewhere 230:10 13l:lO; 134:14; 153:17;
62:16; 6624; 68:21; 16; 179:25; 180~16; 182:4; ! stability 209:19; 216:1,3,
7624; 78:3; 121:24; soon 32:25; 33:22; 70:14 158:4,22; 16O:l4; 1667;
184:7,23; 185:9,20; 170:20; 173:3; 195:13,17, 7; 217:14
141:12; 155:l; 162:s; 186:12; 187:17; 190:5; sooner 33:24,24,25;
181:10,24 18; 1963; 2O4:l; 211:4; ! stabilized 112:s
169:3,19; 172:14,25; 19l:lO; 192:19; 193:13;
256:1,21 sophisticated 45:16; 222:9,12; 223:5; 227:22; ! stable 100:4; 209:9,11,
194:s; 195:5; 19617;
situations 67:3; 151:15; 118:19 228:11,17,25; 229:16,17; 13,23; 217:17
199:9,23; 200:22; 201:9;
164:ll sophistication 48:25 234: 17; 237:4; 238: 15; ! staff 29:s
202:s; 203:21; 204:16;
205:11,15; 2O6:2; 208:3; 245:3,10; 252:9,14; ! stage 7:4,7; 9:20; 10:3;
six 41:17; 89:6; 105:22; sorry 202:16; 227:19
2lO:lS; 211:3; 212:13; 253:6,11; 254:s; 262:9; 1L7:3; 24:4,23; 38:21,21;
107:5; 108:23; 112:25; sort 28: 10; 50:2; 77:14;
113:24; 118:3,7; 12611; 213:7; 214:12; 215:24; 264:7,20; 269:13; 274~24; 117~7;73~12; 77~9; 87116;
81:2; 89:8; 90:3,12; 93:3; 275:17; 283:20,21,24;
209:14,17; 265:13; 216:lO; 217:1,18; 218:2, 97:2;98:10; 106:ll; L40:23; 177:7; 182:20;
294:25 22; 219:5,18; 242:l; 258:6 284:4,7,8; 285:12; 289:7; L86:20; 222:19; 228~24;
119:17; 121:16; 122:14; 290:7,11,11,12; 291:2,3;
six-month 197:7; 209:12, slides 20:13;48:9,12,13, 140~11; 142:15; 148~10; 229~24; 230:5; 236:3;
296: 1 255:19; 256:lS
18; 231:s 24; 56:15; 77:19; 88:25; 151:9; 185:24; 248:21;
93:22; 128:12; 174:3; 249:5,9,22; 250:3,17; specific-at 195~6 tstaged 123:7
size 28:5; 30:6; 96:3
287:12 254~5; 265~2; 266:7 specifically 9:14; 31:21; Istages 50: 10; 68:3,4;
skepticism 144:25; 768; 79:4; 120:4; 134:15;
145:l slightly 94:15; 144:ll; sorts 84:3; 86:23; 107:14; 70~5;173:9; 174:15; 183:3
193:14 112:18; 253:25; 273:18 197:3; 216:6; 224~8;
skills 240:s !stain 83:4,6; 88:1,4,21;
226:7; 236:14
slow 41:5 SOT 150:22; 267~4; 290:1 108:15; 112:17
skin 141:20,22; 144:23; specifications 182:24;
149:2,7; 150:23; 255:s small 10:6; 11:12; 28:5; sounded 271:21 !stained 86:18; 108:14
215:6; 278~3
skip 20:13; 49:25 30:6; 46119; 55:9,19,23; sounds 119:14; 295:2; !staining 88:8,16,17,19;
64:19;95:11;99:8; 101:5; specificity 62:10; 148:3,
296: 15 839:14; 104:l
sleeping 287:20 116:6,9,21,24; 120:4; 13; 154:9; 165:23; 166&l
sources 130~4; 141:13; !stains 83:5,6,6; 88:4;
slice 84:6; 94:17,18,18, 141:23; 143:2; 17618; specifics 273:17
142:5; 214:ll; 220:16 I39:1,10,12,17,22,25;
25; 105:s; 107:s; 109:2; 255:7,15 specimen 109:10,12,23, ,>o:ll, 12;91:20; 108~7;
112:17 space 104:20; 106:24; 24; 112:17; 264:18
smaller 101:24; 104:7; 107: 19; 127:4,7,8 Ll3:12; 132:l; 260:21
slices 87:3; 105:21,22; 115:20 specimens 97:6; 113:8, ,stake 260: 15
106:8; 108:23,23 spatial 91:ll; 95:l; 97:9; 9,24,25; 114:4,6,18,24;
smarter 133:7 101:6; 102:11,24; 105:14; tstakeholder 182:s
Slide 7:15; 8:17,22;9:13, smile 48:20 118:9
23; l&23,24; 11:16,19; 107:13; 108:24; 109:6; stakeholders 8:9; 26:7;
smooth 150:13 110:21; 111:23; 112:3,4; spectacular 80:2; 81:24
13:1,4,19; 14:9,22; 75:16; l&1:5; 292:12
smuggle 99:1 113:15; 114:11,13; 117:7 spectra 168:4 stand 238:1
15:14; 16:2; 17:ll; 18:17,
24; 19:9; 20:3,21; 2212, sneak 98:22,24 speak 48:s; 73:l; 94:2; spectroscopy 85:25; stand-alone 238:6
20; 23:6; 27~20; 29:10; 136:22; 195:7; 250:s; 168:5
sneaks 144: 1 standard 52:19; 74:10;
30:22; 31:19; 35:20; 267~24; 279:3; 295:6 spectrum 30:10; 45:20; B3:6; 85:24; 86:2,6,11;
sneaky 144: 1
38:17; 41:s; 44~24; 45:4, speaker 93:6 59124; 94:13,13; 95:8,9; 87:17; 8814; 89:9,23,25;
SNIDD 129:13 96:18; 138:7,22; 139:19;
23; 46:7,23; 48~5; 49: 1,6, speakers 49:16;71:17; 92:8; 126:13; 127:7,8,10;
19; 50:12,25; 51:s; 52:21; snuffed 43:16 169:13; 173:4; 237:16
79:12; 111:4; 118:14; 148:23; 188:7; 190:13;
53:20; 54:9,21; 55:1,2, societies 21:16; 291:14 181:s; 222:9; 223:22; speculation 35:13 198:25; 199:24; 200:s;
17,25; 56:3,11; 57:5,21, Society 22~7; 49:4; 70:22; 255:25 speculative 65:1 201:s; 203:s; 230:14,21;
22; 58:7,25; 59:8,9; 6018; 75:11; 146:6; 216:18 speaking 180:2; 193:12; speed 92:14 231:ll; 235:20; 261:2,4;
61:14,17,19,25; 62:1,9, soft 80:15; 108:18 205:14; 210:20; 22615; spells 205:2; 208:4 272~6; 273:7,20
18; 63:2,13,14,23; 64~7, software 70: 12; 74: 13; 281:1 standardization 92:6;
24; 65:5,9,18; 66:4,17, spend 7~7; 48~23; 49:12;
75:lS; 120:2 special 11:7, lo; 109:ll; 65:20; 70:3; 95:21; 192:2; 130:20,21,23; 131:1,19;
23; 67:6,19; 68:1,13,20; 154:3; 157:19; 233:1,4
solicit 254:18 263:7 252:13; 256:23; 264:3
69:10,21; 71:9;79:22;
80:10;81:18;82:3;83:19; solicited 21:12; 296:11 specialists 180:4 spent 31:24; 35:3; 98:5; standardize 127:4
84:23;85:21; 86:10,21; solid 32:24; 35:l; 217:13 specialized 117:s; I 244~17; 286~17 standardized 90:24;

singular - standardized (28) Min-U-Script@ Miller Reporting Company (202) 546-6666


Nonclinical Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999
-
92:4; 159:22 Stony 41:19 190:22; 191:8,9,19; subcommittee’s 12O:ll supplement 12:17
standards 122:16; stop 47:16; 110:25 192:4,7,8,2L, 23,24; subcommittees 251:21 supplementation
126:17,18; 244:4; 282:17 storage 130:25 193:4,6,8, i6,19; 194:15; subevolved 14:2 197:lS
standpoint 36:25; 197:2,3,6,6,7,7,7,8,17; supplier 120~6; 215:2
stored 233:3 subject 64:13; 128:19;
204:20; 206:3; 213:23 198:10,19; 199:3; 200:5,
story 56:17,17,18 156:5; 175:14 support 26:19; 28:14;
11,13,17; 2x:12; 202:20;
stands l61:5 straightforward 73:11 subjective 64:16 52:24; 99:10; 185:22;
205:24; 206:13; 211:18;
start 5:25; 6~22; 27:15; subjects 55:10,10; 186:l; 187:15; 188:21;
strain 124:20 217:14; 220:10; 226:14;
47:3; 73:21; 77:16; 78:20; 64:14,20; 16619; 183:5; 189:21; 190:20; 191:8,19;
strains 148:21 228~22; 230:24,24,25;
79:14; 94:12; 95:9; 184:2; 187:3; 198:12 192:4,5; 194:ll; 201:5;
strategies 34:l; 37:12, 231:7,8,9,9; 234:9,9, IQ,
lOO:l5; 107:22; 111:3; 204:3; 207:ll; 259:22;
13; 235:10; 239:4,13,13; subline 35:25
131:4; 134:4,6; 148:ll; 25 270:ll; 272~16; 274~8;
240:17,19; 244:5,14; sublobular 106:15,16
153:13; 186:23; 221:17; strategy 144:8; 152:22 277:5,7; 278:13; 280~22
259:10,18; 261:19; submit 77:3; 125:17;
223:13; 224:2; 230:10,11; stream 257:2 270:10,23; 271:9; 272:9, supported 124:2
232:3,3,5; 241:14; 208~7; 242:15
streamlined 206:i4 10; 273:18; 274:9,20; supporting 186~17;
242~17; 292:2 275:12; 276:3,4; 277:14, submitted 4~6; 193:4; 199:12
strength 115:13,24;
started 39:l; 95:15,16; 17,20; 278: 10,17; 279: 17, 207:21; 21&l; 219:13; supposition 243:14
2065; 214:14 220:4,13; 235:4; 241:6
98:lO; 99:6; 108:lO; stress 139:3; 163: 1; 25; 280:12,13; 281:10; suprapharmacology
112:7; 136:4,13; 221:15; 285:9 submitting 5:6; 212:5 168~7
175:14; 249:16
223:13; 270:25; 294:23 studies-usually 186:14 subsequent 91:2; sure 24:7; 33:21; 50:s;
stressors 167322
starting 30:25; 71:22; study 33:5; 35:21; 38:12; 288~19 71:23; 75:14;93:7; 121:2,
striata 55:19 subsequently 93:15
129:s; 187:2; 204:9; 41:11,12,16,17;42:3; 13; 126:18; 129:5; 146:6;
231:23; 241:25 striatum 55:22; 56:6,13, 44:8,15; 54~22; 55:15; substance 51:24; 155:14; 223:2; 22620;
23; 57:4,8,9,20; 58:15; 59:2; 6Oz23; 67:16; 69:ll; 182:23; 183:s; 211:6; 244:25; 245:9; 250:14,18;
starts 39:23
63:17 71:20;77:11;84:25;85:3; 212:16; 213:6; 214:10,18, 253:s; 255:3,5; 257:7,18;
state 235:5
strikes 284:10,11 95:l; 113:ll; 128:18; 22; 216:3; 217:2,15,21; 269:17; 271:5,24; 278:7;
stated 123:14; 202:9; 150:5; 154:12; 167:15; 283:21; 286:1,12,14;
strikingly 9613 220:16; 276:2; 280:4
27613; 277:12; 285:4,10 173:25; 185:14; 186:15, 289:6,9; 290:4,24;
stroboscopically 106:5 substances 214:24;
statement 75:12; 278:19 16; 189:12,21; 190:7,20, 216~5 292:24; 295:18,19
stroke 95:24; 96: 1;
statements 5:5 21; 191:21; 192:13,21; substantial 28:6; 44:lO; surely 37:9
116:18
states 25:21; 121:20; 194:12; 195:10,13,20,22; 273:12 surface 12:l; 19:3;
Strong 27:23; 88:8,18; 196:8,23,23; 197:14;
179:lS; 201:12; 203:15; 296:4 substantially 269:25 34:20; 117:5
218:lO; 263:13,13; 198:2,12; ~~16; 200:14; surfaces 18:13
stronger 101:3; 112:5,5 201:3; 204:3; 206:20; substrate 36:10
270: 24 surmise 252:6
strongest 84:21 208:9; 209:7,9,10,12,12, success 59:13,14; 69:7;
statistical 122:23 16,17,18; 210:16; 211:14; 249:12; 268:19 surprise 98~20
strongly 225:9
statistics 1615 212:2; 217:17; 218:3,12; successful 59:6,7,18; surrogate 13:15;45:15;
struck 100:14
status 156~3; 161:4 22O:lS; 226:ll; 230:20, 170:16; 229:9 59:11,13,20;67:14,18;
structural 85:15; 86:14; 20; 239:12; 256:10; 137:23; 138:15; 139:8,12;
stay 1l:ll; 15:7; 104:3; 87:5; 105:lO; 106:9,13; sudden 37:17; 47:4
209:19; 277:lS 271:20; 272:20,21,22,23; 153:21
107:l; 109:15,22 suffered 56:21,24
steak 109:4 273:20; 274:5,21,22; surrogates 41:25; 93:15;
structure 14:ll; 40:3; 277:5,9,11; 282:21; suffice 20:14; 212:19;
stearate 216:14 275:14
83:9; 84:19,20; 106:15, 294:13 214:17
steering 21:23; 291:20 17; 108:3; 109:25; 125:10, surround 28~20
study-do 231~5 sufficient 105:17;
stems 143:ll 23; 209:4,5; 210:2; 216:16; 23o:ll survey 15615; 157:15;
213:11,13; 273:5; 275:1 study-design 203:18 17620; 203:2; 253:5;
step 53:18; 63:24; 7516; sufficiently 117:9;
structures 108~21; studying 58:23; 167:21 283:24
91:2; 159:14; 163:ll; 165:lO
230:7; 243:7; 254:6; 209:l; 256:14 stuff 93:3; 99:16,17,17, survival 45:14
suggest 126:19; 223:23;
278:5,14; 282:5 structuring 23:17 18; 121:22; 127:18; 128:4; susceptibility 137:7,14,
243:13; 253:2; 267:lS
256~24 15; 143:l
steps 90:15; 13625; struggle 71:25 suggested 36:ll;
176:24; 214:3; 260:1 stumbling 30:17 susceptible 137:9; 143:2
students 47:16; 102:21; 110:22; 116:22;231:1,1
sterile 207:12; 210:13; 106:19; 107:3; 113:lO; subcellular 259:15 suspect 102:6; 119:21,
suggesting 241:19
217:7,12 124:16; 291:15 subchronic 256110 23; 240: 1; 283:9
suggestions 113:3;
sterility 210:14; 220:1 studied 43:21; 128:19; subclasses 228:20 24610 swamp 118:ll
sterilization 219:22,23 191:6; 193:22; 209:20; subclinical 77:9 suggests 150:16; 216:4 swamps 110:15
sterilized 217:9 210:23; 258112; 259:10 Subcommittee 4:4; 7:5, Swinberg 239:21
suitable 259:4
sticks 42:17 Studies 4:4; 8:6,7; 17:14; 12,19; 8:3,12; 9:22; 11:9; switch l61:6
summaries 202:5
23:2; 29: 14; 36:7; 37:7; 21:2,3,22; 22:8,12,17, SWOG 69:6
stigma 176:s; 233:22 summarize 49:15; 54:10;
40: 14; 44:20; 56:s; 67: 17; 23; 23:8,22; 28:8,18;
still 30:16; 40:3; 43:14; 64~8; 154:19; 194:9 sympathetic 294:6
68:7,12; 69:l; 70:6; 71:l; 46:21; 48~7; 50:3; 68:6,19;
46:18; 52:5; 68:14; 69:5; 74~24; 75~3; 77:22,22; 70:8;71:11,23;72:10,25; summarized l3:4; symposium 267:5
72:20; 78:s; 119:5; 146:5; 91:10; 93:lS; 95:10; 73:5,6; 75:14; 79:6,7; 201:25 symptom 60:21,24
147:19; 148:7; 191:7; 107:24,24; 112:23; 113:s; 111:7; 118:15; 156:13; summarizes 11:19 symptomatic 60:12,15
193:21; 203:13; 206:18; 114:4; 116:6,14,16,19, 221:2,4,10; 222:14; summary 202:4,14,16 symptoms 60:19; 61:1,
219:25; 229:25; 239:22; 23,25; 117:13; 124:2; 223:16; 224:l; 229:lS;
245:19; 269:18; 270:l; sums 253:17 5; 64:4
125:6; 165:lO; 182:14,14, 230:6; 243: 15; 246:4; synapse 63:6,20
272~3; 273:12; 276:12; 16,20; 183:15; 185:12,22; 260:7; 267: 18; 269: 15; superconducting 118:4
279:23; 283:19; 284:5,24 186:1,2,3,5,18,25; 279:12; 281:3,14; 286:1, superconductors sync 93:3
stimulate 235:4 187:15,21,22; 188:1,3,4, 13; 287:18; 295:16; 113:21 syndrome 5622; 58:13
stimuli 179:20 13,18,21; 189:18,19; 296:20 superior 163:4 Synthelabo 6:15;61:17;

Miller Reporting Company (202) 546-6666 ~in-l~-%x=ipt-~~ (29) standards - Synthelabo


Hearifkg Nonchid Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science

.i29:14 talking 7:s; 32:2; 53:s; technology 8:25; 9:ll; terrific 39:9 250:23; 290~25
syntheses 277:19 63:4; 71:18,19; 77:20; 11:23,25; 12:22; 15:22; tesla 97:24,24,25; 9812; third 83:4; 90:9,25;
82:14; 102:2; 107~17; 25:10;30:1;41:10;44:25; 109: 14; 112:7,8,9,10,10; 99:15; 106:21; 107:9;
synthesis 61:6,7; 73:13;
210:l; 220:4 108:19; 119:17; 126:lO; 71:14;76:22;94:1;98:5,7; 115:7,12,23,24,25 235:12; 28816
130:24; 131:22; 139:12, 113:5; 114:17; 117:20; test 124:18; 239:3,7,12; thirty 257:14
synthesize 180:5; 278:1 13; 151:15; 181:4; 185:ll; 119:ll; 121:23; 128:l; 240:3; 255:s this-but 21:s
synthesized 282~22 186:9,13,16,19; 187:9, 129:5,6,25; 13O:l; 140:5;
tested 270: 17 this-l 193:16
synthetic 220115 11; 188:2,2,24; 190:7,8, 14616; 151:21,22; 152:1,
9; 19625; 197:1,5,20; 16,18; 153:5; 158:13,20; testicular 167:s this-there 234:22
system 37:lo; 39:10;
52:10,12; 64:ll; 83:24; 198:1,4,9,9,12,13,16; 159:11; 160:7,12; 184:lO; Testing 64; 11:7; 27:22; thorough 26:23; 155:14
84:14; 85:25; 97~14; 98~2, 201:25; 204:2; 206:18; 233:4; 235:16; 236:4; 35:18; 39:9; 45:5; li9:2; though 31:15; 35:3; 45:5;
12; 99:25; 103:9; 105:l; 207:s; 213:5; 221:7; 254~17; 256~4; 257~8; 128:16; 190:24; 198~14; 89:19; 126:21; 132:22;
111:15; 121:21; 122:8; 224~4; 226:s; 231:17; 259:1,3,20; 260:4,8; 199:18; 203:11,11,15; 133:13; 181:22; 182:21;
140~2; 220:3 234:10; 235:18; 242:18, 261:22; 264:21; 276~10; 229:23; 232:6; 238:18; 193:18,19; 271:12
22; 254:lo; 255:l; 257:12, 289:12; 292:19 243:2; 256:12; 266~17;
system-let 115:12 270~4 thought 10:3; 11:13;
14,15,23; 258:17,18,19; technology-derived
systematically l34:4,6 32:23; 117:3; 128:24;
259:25; 262:4,11; 267:3, 199:21 testosterone 167:9
systemic 10:5; 11:14; 130:19; 161:10; 195:7;
9; 276:20,23; 292:25 tests 23:l; 44~22; 161:22;
tee 253:6; 275:13; 200:5; 224:22; 239:4;
172:12; 245:11,12 talks 140125; 191:7; M&24,25; 165:6,7;
288:11,19 242~2; 250:21; 251:9;
systemic-based 245: 15 200:8,11; 205:22; 210~19; 235:21 270:17; 271:25; 273~24;
teed 263: 11
systemically 58~16 211:5; 215:5; 280:13; thanking 111:3 285:15; 288:10;292:15;
281:4 teleconference 70:24;
systems lO:ll, 19; 13:7, 294:10,17; 295:1,5,9 Thanks 79:21; 131:22 293:12,15
8,9,12,14; 16:24; 32:23; target 29:23; 32:12; 33:1, that-and 284:lO thoughts 35:13; 76:5;
3, II, 14,16,22; 34:4,6, telling 46:l; 47:16; 49:s;
46: 15; 90: 18; 97:23; that-that 249:1 156:7; 235:4
23; 38:5; 39:7,11; 40:25; 127:19; 173:18
112:9; 122:s; 196:ll; three 39:3; 40~20; 44:16;
198:5; 247:9,12,13 41:1,21,23; 42:5,18; tells 43:18;44:22; 137:6 the-if 257:12
59:ll; 80116; 84:7; 88:3;
43:19;44:18;45:7;46:15; temperature 100:2; the-we 225:13
90:5; 94:6; 97:23; 100:14;
50:9; 138:4; 161:20; 113:21
T 181:14; 245:5; 265:17; temporal 91:ll; 101:5;
theme 28:7; 51:5
therapeutic 9:2; 29:3;
106:23; 118:2,6; 128:25;
158:7; 170:23; 175:l;
278:21; 286:21 128:17,23; 174:17 30:2; 39:15,17,21;40:8, 181:6; 182:12; 185:23;
T 144:19; 147:3,6; targeted 55:9; 149:7; temptation 76: 11 10; 42:12; 43:18;44:16, 193:5; 199:15; 229:3;
148:12,19,20; 228:18 180:2 tempted 164: 15 17;47:1; 121:1; 168~14; 236:18; 260:23; 264:18;
t’s 279:7 targets 29:18,21; 34:6,9, ten 46:9; 114:lO 172:6; 173:7; 186~22; 269:22; 272:19; 288~4;
Tl SO:25 21; 39:10; 40:3; 233:12 193:ll; 194:22; 228:l; 294: 17
ten-minute 220123 233:ll; 266:s
T2 80:25; 103:7 task 85:20; 128:20,20; three-dimensional
130:ll; 154:16 tend 13:lO; 173:6,11; therapeutics 29:20;
T3 175:4 194:16; 225:13,18 260:22
tasks 269:16 39:4;45:12 three-month 197:7;
table 29:6; 182:lO; 216:4; tendency 167:3
TE 103:7 therapies 45:2,3; 180:2; 231:s
237:l; 248~8; 253:16; tenth 215:17
teach 124:15; 291:5,6 181:18,24 threshold 154:s; 173:19
292:l; 293:9
terabytes 127:22 therapy 33:25; 59:1,6,
tablet 207: 10 team 27:24; 79: 15; threw 48:18
211:20; 279:5 teratogenicity 173:5 18,18; 60:12; 69:8,19;
tabulations 202:4 thrilled 75~4
teratology 197:4 147:23
tackmen 158:14 technical 23:ll; 112:2 throughout 127:7;
term 73:20; 143:25; there-there 146:5
tailored 227:13; 256:21 ethnically 262:9 209:9; 222:5
181:21; 183:6; 204:22 thereby 163:5; 168:6
talk 6:24; 20:5,12; 27:16; technique 60~17; 76:18; throughput 8:25; 15:24;
77~18;90:5; 134:12; terminal 219:22 therefore 47:24; 48:13; 152:25; 178:21; 256:7
31:20; 35:12; 47:25; 50:22; 51:22,24; 54:3,5;
L71:15; 256:17,24,25; terminate 77:9 thrown 106:lO; 183:7
61:15;90:11;94:4,7,9; 55124; 56:7,20; 58:18,24;
99:10; 108:16; 111:18; 262:19; 264:13; 265:l; terminator 106:12 tied 108:17; 129:17
266:3,4; 267:15 59:5,18; 62:7,16; 63:6,
127:13; 133:14; 136:19, terms 7:10; 30~1; 45:ll; tiered 196:21,25
2 1; 64:4; 65: 15,24; 66~7,
19; 137:12,13; 139:20; techniques 92:15; 94:17; 46:3; 52:4; 60:14; 67~22;
14; 67:3; 77:9; 129:2; time-consuming 72:lS
154:4; 177:16; 181:18; LO8:5; 125:2; 258:14; 69:l; 78:25; 80:13,25;
158:21; 159:11,20; times 40:22; 86:22;
182:17; 184:21,24; 266:13; 267:6,6; 268:6,11 82:s; 85:ll; 86:14,18; 160:14; 163:22; 164:20;
185:13,16,21; 190:6; 89:13;90:4,15;91:13,20; 89:15; 101:3; 102:12;
technologies 8:25; 9:1, 165:17; 168:lO; 169:12;
192:6,11; 195:6,8; 94:20; 115:s; 117:4; 112:13; 115:20,21,25;
6; 12:20; 14:25; 17:23; 17017; 173:18; 175:24;
199:15; 200:24; 201:23; 123:5,16; 124:3; 132:15; 116:13; 14l:lO; 143:12,
18:1,2,11,23; 25:13,14, 186:20; 229:ll; 251:15
204:17; 219:7; 222:20; 133:9; 134:5; 138:1,6; 15; 155:16; 179:ll;
19,24; 26:13; 27:15;
223:19; 225:13,21; 226~2, 141:9; 144:6; 158:4,21; thereof 234:21 191:21; 206:16; 215:3;
50:17,19,22; 51:10;
5; 234:ll; 237: 10,24; 163:8,8; 169:lO; 180:25; these-because 230:23 225:5; 236:13; 266:6
70:14; 83:17; 98:9;
239:21; 243:11,12; 247:5; 112:22; 113:lS; 123:6,8, 183:10,20; 185:18; 189:3; these-we 294:3 tiny 43:14
253:4; 255:13,13,13; 17,20,21; 124:4,6; 190:7; 191:5; 195:9; thesis 155:4 tissue 9:3; lO:l, 8,ll;
262:17; 275:14,15; 129:ll; 133:4; 146:2; 196:13, 18; 199:12; 201:s; thiazolidinediones 18:lO; 19:2; 20:9,17;
292:21; 295:5 153:1,2; 156:24; 157:20, 202:ll; 203:l; 226:l; 170:22 42:17; 51:2,3,3,6; 54:6,
talked 18:21; 81:14; 20; 178:1,6,15; 179:2,3; 231:25; 234:16; 249:23; 7; 66:10,14,16,16,18;
253:s; 254:3,8; 255:21; thick 94:25
89:22; 131:23,24; 154:l; 180:11,14,24; 183:20; 71:18;80:15;83:12;84:6;
226:18,25; 257:ll; 258:3; 256:5; 262:5; 263:12; thickness 94:18 86:24; 87~20; 94~21;
189:8,18,19,20; 201:17;
202:23; 204:l; 208:6; 259:6,11,12,15,21; 269:13; 275:21; 277:4; things-and 125:s 108:3,17,18; 113:2;
211:16; 223:22; 224:19; 263:12,18; 264~8; 265:12; 279: 17; 280: 14; 282~24; thinking 2O:l; 22:16; 114:20; 138:5,24; 144:22,
227:6; 230~14; 251:2,3; 275:15; 276:16,19; 285:7,15; 28621; 287:3, 34:24; 68:22; 72:12; 99:6; 23; 145:6; 166:17; 174:24;
265:l; 270:8,13; 271:4; 282: 14; 284: 14; 286: 18; 4; 288:6,6; 292:17; 293:6 126:3; 134:16; 167:4; 175:19; 228~11; 229:10;
273:9; 279: 1; 289: 1 289:14,21; 29O:lO terribly 103:12; 245:17 185:15; 242:20; 248:10; 236~19; 246~8; 247~7;
-
syntheses - tissue (30) Min-U-ScripiQ Miller Reporting Company (202) 546-6666
Hearing
Nonchicd Studies Subcommittee of the
Advisory Committee for Pharmaceutical Science December 14,1999

249:21; 259:13,16; tcepics 10:l; 31:5; 49:16; tc,xicologically 122: 11 ‘eatment 39:4,7; 58:24; 96:9
261:17,17 195:7;221:m;222:1; tc>xicologist 6:lO; 3:11;96:4;149:16; rying 24:25; 31:25;
2152:25;288:4,10,12 208:20;209:5;210:5 31:ll 6:19; 99:1,2; 109:5;
tissue-specific 12:7;
ttbpographic 131:20 *eatme& 69:12,13; 27:2;173:20;179:9;
, 2O:l; 142:l; 228:8 tc3xicologists 132:16,
79:9;233:23 so:7,10,19; 181:12,14,
tissues 10:18,19; 11:5, 1‘OPPER 4:12; 290:17; 2 5;220:7;291:6
‘ees 125:1,1; 131:19; :5;182:11;184:21;
6; 15:19; 19:8; 33:9; 35:l; 2!95:9 tcDxicology 11:14; 22:7;
51:14,19 9616; 204:3;239:1;
65:13,14,15,25; 66:1,22; ttotal89:13; 172:12; 49:lO; 54:16; 56:14,17; :55:17;262:8;265:21;
113:4,12,13;235:8; 189:3;193:15 58:22;76:13,20;84:18; emendous 11: 17;
173:24;274:24;275:7;
261:18;264:15,22 tiotally 143:13,20; 910:19;107:23; 110~6; 0:23;25:8,12;37:9;
:80:10; 281:6; 288:23
title 205:12 187:19; 225:2,9,22; 24~4 1 11:lO; 132:17; 134:5; 9:18;79:25;80:23;
146:7;165:10;172:16; 83:21;214:4;222:7; ucked 97:2
to-is 287: 16 tfouch 5:22; 225:1,3 umor 33:1,1,12,20;
182:14;185:14,22;186:3; 60~25
to-it 78:21 ti ouched 181:8 ,6:12,15,15,18,18,23;
187:5,21; 188:18; 189:3, epidation-a 196:21
to-just 22615 tfough 240:9; 263:8 2:o; 190:7,11; 192:22; ~7:1,19,21; 38:2; 149:10;
-ial 44:22; 143:4; 186~15;
to-we 2569 t1oward 145:21,25; 195:10,19; 197:2,5; 87:2;188:12;201:5; 86:3;262:20;264:14
today 9:21; 10:2; 22:9; 2!12:20;254:16;257:1; 198:19,23,23; 199:13; 08:2;209:20;215:14,14; umors 32~24; 35:24;
48:10,11; 50:4; 51:ll; 2!83:17 2iOl:l, 4; 202:3,17,18; 82:l &3;37:15;65:16; 262:lS
54:8; 56:14;71:18;82:4; t1owards 95:3,9; 101:20; 2103:18;204:3;234:9; ials 15:17,20; 25:20; une 146:25
83:20;94:2;101:5;109:3; 1.05:6; 119:l; 160:20; 2:37:24;243:17;244:2,5, 6:10;39:1;40:2,7;45:15; urn 4:9; 5:21; 15:6,7;
112:23;118:3;128:13,14; 196:l 14;257:2;267:8,10; ;1:19;165:5;262:21;
7:3;64:14;68:5;72:21;
137:18; 139:12; 141:lO; t1ox 27:12;117:13;119:3; 2:71:6; 273:6; 274:20; 18O:lO
01:20;122:23;177:17,
151:21; 156:2; 161:5; I.22:4;227:6;229:22; 2175:21; 276:3; 280:5 urned 15:ll
8,22,24;179:14,17,19,
162:13,20; 168:lS; 2!34:25;235:21;236:8; tcoxin 85:16; 137:6 0; 180:6,7;181:19; urning 256%
171:16; 183:19;184:24; 2!42:22;243:6;270:1; Boxins 141:5
204:1,18; 222:12; 23O:lO; 82:6,19; 183:l; lfkkll, utorial 292:25
4!71:21;273:8;277:6; tloy 121:lS 4;185:13,23;186:24;
233:1,4; 235:14; 238:25; 2!87:21 -welve 113:17
260:17; 261:11,13; 281:5; tfDYS 107:18;122:7; 8&21;189:22; 191:12;
t oxi 256:lO wice 43:6,9,13; 44:7;
285:4;286:21;293:23,24; 134:lS 99:13; 206:23; 207:4,7,
t oxic 76: 12,24; 77:7; ,;210:22;211:24;257:25; .17:2
294:12;295:4 t racer 38:8,9; 42:16; wo 9:5;13:6;18:5;22:5;
f t4:21;158:3;160:15; 68:19,22;269:20,25;
today’s 5:4; 7:4; 156:6 5i2:9,11; 54~24; 56~2; 62:7, i5:24;37:1;40:5,20;
I166:22;172:8;173:15,17, e!;66:21;70:4,5;73:14 ,70:7,16;272:6,7,10,14;
today-maybe 261:l I19;186:24;188:2;197:9; :78:13; 282:ll; 284:2; iG:20;53:9;60:25,25;
together 29:21; 47:12; 2!09:6;225:19;249:12; t racers 49:13; 50:7; ;1:5;65:20,24;66:2,8;
c>;1:21;57:24;65:1;69:25; :87:1
74:20;84:25;134:25; ;!66: 18 ‘riangle 1Ol:lS ;7:1,5,17;69:5;73:23;
202:19;206:17;222:17, 7~1:19,20,120:16 15:9;88:25;89:2,2;
t:oxicants 167:22 rick97:13; 112:14,20,
23;226:16;235:19; t rack 194:5; 251:21; .03:23; 113:lS; 118:2,2,
1:oxicities 143:25; 144:3, 2!60:14;296:5 10
240:24; 241:ll; 243:9; 1j; 168:2; 169:21; 188:14; i; 122:17; 130:17,18;
248:20;251:8;258:24; I1?31:25; 240:13,20,23; t racks 251:24 ried 41:24; 237:9; 249:6; 156:8;158:7,8;170:18;
259:1;262:7;268:11; !77:10 185:23;186:7;187:5;
‘~41:17;242:2;244:6; t rade 6:7; 21:15; 97:17
289:12;290:8,20;293:13; rigger 100~2 t90:8,14;192:17;197:8;
245:16;252:21;278:17, t radeoffs 113:15
294:5;295:3 riggering 100:7 !OO:lS, 18; 218:lS;
21 t .raditional 33:6; 168:15; ~21~19;223:22;225:14;
told 89:20;104:14,15 1toxicity 10:5,17; 20:6; r!30:21; 234:s rimmed 45:25
!27:7;229:3,9;230:15;
tolerable 164:18 38:6;43:22;77:8,12; ;:rain 70:16,17; 180:4 ripartite 276:21 !48:10;252:16;260:25;

tolerance 176:14; i31:16;88:2,10;91:14; IIraining 70:12,21; 155:4 rivially 127:11,12 !74:20;275:23;277:6,6;


200:13; 245:23 ,?2:3; 119:12; 131:6; rophic 175:3,11
1:ransfer 71:15; 122:12; 184:4,15;285:22;288:5;
tomographic 31:2 132:21; 133:7; 137:3,9; roponin 144:19; 147:3, 289:23;290:7,9;291:3;
1L28:9
Tomography 27: 17; 138:25;139:2,5,9,10,13, i, 10; 148:1,2,12,20; 294:17;295:11,17
17;140:9,11,17,22; 1 :ransferred 92:s
28:4,20,25;30:24;31:21; !28:18,19;230:18,23,25; 1two-week 197:6;230:15,
142:9,11; 144:20; 145:17, i transgenic 12:21;
34:8;35:15,19;46:9;48:3; ; ,24;146:22;147:14; !49:13,18; 255:8; 277323 20;276:3;277:17;278:17;
133:lO
49:20 roponin-T 175:9 28O:ll
159:21;160:18; 161:1,20; 1transition 118:23; 119:7
tomorrow 267:lO 162:4;164:17;165:19; :roponins 20:6,14; two-year 239:4,11;
1translate 237:22 256:lO
tons 99:16,16 167%; 168:4,8,16; !28:17,20;293:17
1translates 111:22 type 11:3; 41:22; 42:4,20;
Tony 69:6 169:10;170:2,3,6,8, 14; :rouble 188:12; 232:18
173:4,4,8; 174:6;187:12; 1translating 53:3 43:15,16;84:21;167:20;
took 89:9,12;94:12; :rue 35:lO; 54:18;87:19;
106:4;116:24;202:9; 189:18,19;190:10,17,18~ ; ’translation 98:7 196:24;248:7;270:3 168:2;171:5;174:25;
198:6,7;200:16,17; itransport 32:23; 36:l 197:23;205:2;206:20,21;
239:9 truly 72:7; 111:20; 127:19
208:21;225:24;226:10; transported 90:23 207:10;211:4,19;212:14;
tool 31:14; 33:13; 34:22; try 11:11;35:12;40:18;
229:3;234:7;237:14; 213:5;228:9;234:9;
39:17;40:4,9;81:12; transporter 55:21; 57:l; 52:23;74:9;94:6,8;
238:21;240:25;246:6,7; 246:6;264:23;269:2;
83:20; 116:25; 118:21; 58:1,5;63:4,5,19 110:14;127:14; 131:13,
249:17;250:11,25; 286:14
176:20; 198:17; 238~11; transporters 32:17; 15; 152:23; 158:7; 174:4;
260:18;262:23 252:12;265:20;266:8,11, types 14:17; 19:7; 20:19;
56:13; 57:s 180:20,22; 181:17;
15;272:25;280:5 35:24;125:23;157:2;
tools 31:10,16; 32:9; transporting 32:19 19O:lO; 191:15; 199:l;
toxicodynamic 138:3, 167:18;185:4;186:10;
33:6;41:2;64:10;134:17; trapped 104:24 202:24; 211:ll; 222:14;
23 198:10;203:25;204:1,6;
157:21,23;184:10; 226:lO; 229:3; 232:19;
toxicokinetics 225:14 travel 98:17 205:23;207:4;228:11;
198:17;238:10 238:12,15; 241:17;
treat 25:l; 262:22 254:24;257:22;262:15; 229:3;234:23;253:12
top 156:3 toxicologic 167:16;
189:21;191:5;238:24 treated 8~6; 105:3,14; 266:6;276:5; 28i:13; typical 53:22; 63:16;
topic 56:13;94:5; 156:15 98:2;102:10
17;177:21;199:10;290:9 toxicological 168:20; 152:2,20 283:2;284:6;287:23;
I 169:4;170:24 I treating 38:2; 147:20 288:20;289:5,13;291:16 Typically 103:3,9
291:3

Miller Reporting Company (202) 546-6666 Min-U-Script@ (31) tissue-specific - Typically


Hearing Nonclinical Studies Subcommittee of the
December 14,1999 Advisory Committee for Pharmaceutical Science

typo 136:lS unique 4:24; 25:15; 242:16; 272:13 236:8; 239:24; 266:2; 259:19; 285:5; 289:24
?. 50:13; 51:19; 108:4; upper 3616; 42:19; 43:4 286125; 293:9 valve 10O:lO; 1Ol:lO
-, 165:24; 190:2; 263~7 uses 190:21; 266~20
U uniquely 51:11; 267:2,
upregulated
upstream 63:12
247:l
using 10:17; 11:24;
van 128~6
vantage 155:12; 248:6
21 uptake 36:21; 62:2 15:16; 20:2; 21:12; 35:14; vaporize 152:18
u.s 112:9; 127:7; 200:4; unit 27:23 38:s; 48:9; 55: 15,20; 567;
201:14; 203:ll; 205:18; urine 33:7; 142:4; 166:25; variability 64:14
United 121:19; 201:12; 57:24; 58:2; 61:7,8; 62:14;
213:16; 271:2 168:5 63:24; 64~5; 69:3; 71:23; variably l91:3
203:15; 218~10; 270~24 us-two 294:24
U.S.-European 146:5 74:10; 88:17,24; 89:25; variation 232~6
units 27:22; 28:13; 51:13; usable 118:24; 229: 10
Ulrich 1463 92:8; 93:19,19; 95:10; variations 148:22
119:22; 257:17
ultimate 18:16; 34:12; USC 5~2 113:19,20; 114:25; varies 85:8; 103:22
University 70~23; 92:20; 117:19,25; 121:7; 132:20;
45:12; 140:9 107:4; 1164; B22:19 use l&5,10; 19:3,5; variety 14:3; 80:24; 89:l;
2618; 3611; 40:4,X8; 133:5, lo, 20; 141:6; Xk18; 157:21; 229:ll
uftimately 29:l; 53:l; unknown 17612 142:15; 14723; 149:7,13;
84:13;92:12; 125:6; 41:24; 51:20; 55:21; various 12:ll; 28~13;
unlabeled 40~10 62:15;65:3;66:2;67:12; 152:l; 153:2; 161:1,21;
130~7; 138:11,24; 141:12 179:l; 181:9,17; 18617; 55:7; 91:23; 103:l;
254:13 unless 29:12;41:1; 69:7; 70:19;71:16,19; 123:17,24; 133:9; 158:14;
85:13; 200~16; 241:23; 74:13;81:12;82:5;83:24; 187:25; 191:21; 196:12;
unacceptable 77:13 218:3; 228~8; 233:3; 159:4,6; 167:22; 193:22;
283:9; 292:20 85:9; 89:23; 10612; 195:23; 197:14; 198~16;
unaffected 33:lO; 37:22 110:17; 112:5; 121:9; 24621; 247:2,3; 248:2,3;
unlike 62:17; 116~12 254:16; 259:6; 262:24; 200:2; 207:3,4; 214:3;
unanswered 76:19,20; 122:25; 123:11,11; 125:4; 226:5, lo; 227:4; 260~21;
unlikely 30:17 264:13,21; 265:l; 27619;
244:3,3 132:17,25; 133:6; 138:2; 267:14,25; 271:18;
unmined 46:3 278:22,23
uncertainty 138:9; 143:20; 148:12; 149:12; 274:16
139:15; 148~17; 153:22 unnecessary 41:7 150:17; 152:13; 153:5,23; USP 212:17,19
usual 274:5 vary 206~12; 279:19
unchartered 72:3 unprecedented 8:20 157:18; 159:12; 160:14;
162:15,17; 164:24; Usually 34:lO; 82:13; varying 184:2
unclear 17:17; 272:3; unquestionable 80:4,12
166:21,23; 169:11,17,17; 84:20; 94:17,25; 196~8 vascular 80:20; 109:16;
274:lO unsafe 187:8; MM:11
170:7; 171:20; 172:20; utility 25:14; 28:22; 150~12
uncover 181:17; 234:lS unstable 209:24 vasculitis 145:5; 150:3,
176:16,25; 179:2; 180:18; 58:18; 68:16; 69:9; 70:6;
uncovered 208:15 untoward 235:8 184:5; 185:ll; 186:7; 95:17; 134:ll; 140:19; I, 24; 151:4; 228:14,14;
uncovering 151:24 untreated 152:3,20 189:2; 191:13; 194:23; 161:11; 162:2,15,24; 236:19; 237:3,12; 240:3;
under 33:9; 57:24; 118:5 unvalidated 72:3; 123:20 19620; 197A6; 198:17, 164:21; 169:23; 177:9; 244:23; 254:21; 255:9
7; 120:5; 175:1,17; up 18:7,11; 32:18;35:12; 21; 200:2; 210:22; 212:24; 189:lO; 252:lo; 259:ll; vault 42:6
213:17; 247:12; 277:21; 36:16; 41:14; 48:15,19; 216:14,15; 218:lO; 264:1,8 venous 175:15
283:6 62~6; 64~8; 65:21,22,25; 226:20,21; 227:3,9; utilization 259:4,21 ventilate 105:lS
undergoes 186:25 66:10,12;70:13; 73:18; 228:8,21; 233:4; 235:6, utilize 165:9; 221:8;
13,15; 238:2,12,12; ventilators 99:17
88~24; 89:5; 90:2; 92:14; 240:5
underlining 213:8 239:16,18; 244:lO; ventilatory 101:9
93:5,25; 96:17; 97:3; utilized 25:19; 119:4;
underlying 28:25; 157:4 98:17,24; 100:5,14; 253:21; 258110; 260:3; ventricular 175:9,12
underpin 182:15,18; 262:17; 264:19; 265:3,8; 148:6; 183:24
104:20; 105:13; 108:17; ventures 46:6
27618; 285:9 110:12; 111:5; 112:ll; 266:13; 268:lO; 290:18 utilizing 119:l; 123:17
uerapamil36:6,8,14,17,
underpinning 29:l 115:15; 119:9; 127:7,17; used 5:19; 10~4; 12:8; UV 149:6,16,18 21; 37:5,16,19
underpinnings 27:2; 129:17; 130:10,16; 14:18,19; 20:10;41:10; verified 125:16
184:13,13; 269~24; 280:2
285:6,13
133:14,16; 134:19; 144:l;
146:7; 147:16,17; 148:12;
50:21; 54:4,8; 56:9,9;
61:22; 67:13; 68~11;
V verify 91:3
155:5; 159:9; 164:12; 74:21,22,23; 80:20,23; versus 77:23; 89:13;
underserved 30: 12 113:13; 132:17; 133:2;
177:13; 181:15; 188:ll; 81:13; 83:21; 85:23; valid 138:20; 177~2
understands 226:15; 19O:lO; 197:21; 198:20; 86:lS; 89:18; 92:ll; 153:21; 189:s; 226:6,7;
validatable l39:9
285:24 204:ll; 207:13; 208:14; 123:20; 128:2; 130:22; 231:8,9; 247:9; 261:4;
validate 69:7; 73: 15;
understatement 31:s 210:17; 215:13; 216:21; 133:24; 138:16; 143:19; 265:17; 26618
87:17; 91:3; 132:2,3,4;
understood 19:17; 61:2. 218:ll; 223:6; 224:15; 144:24; 147:19; 151:3,8; 181:16; 199:l; 215:4; vesicular 58:l
77:7; 129:15; 159:22; 225:19; 229:6; 233:9; 157:20; 172:16; 175:2; 232:lO; 234:21 via 87:s; 236:23; 289:7
272:23; 294:2 238:3; 239:ll; 243~22; 183:ll; 191:11,11,13,17, video 97: 1
validated 45:17; 65:2;
undertake 166:19 244:2,8; 246~4; 248:4,24; 22,23; 192:4,5; 194:18, 123:25; 148:2; 260~24; videoconference 71:2,6
undertaking 246:15,16 253:6,17; 254:19; 256:6; 23; 195:24; 199:s; 201:2; 261:l
257:9; 258:2; 263:ll; 202:4; 206:15; 207:6; view 31:3; 50:17; 1OO:ll;
underutilized 166:25 validation 49:14,15; 131~19; 164:9; 189:6;
264:14; 267124; 275:13; 211:23; 212:7,25; 214:8,
underway 112:2; 118:5; 276:19; 281:3,13; 288:11, 14; 216:2,6,12,20,22; 68:5,10,18,21,22; 70:7; 225:3; 24716; 249:1,4;
156:lS 19; 291:13; 292:14,16; 218:5,8; 226:23; 229:ll; 72:5; 73:23,25; 75~7; 277:15
underwrite 182:19 235:9; 238:20; 239:19; 120:22; 131:23; 132:6,11, viewed 139:8; 252:7
293:5
undoubtedly 124:17 242:21; 247:6,14; 248:21; 12; 148~16; 154:4; 198:20, viewpoint 41:12; 44:16;
up-front 278:lO
249:2; 251:lO; 254:12; 23,25; 215:6,9,20; 118:18
unfixed 117:22 up-regulated 15:3,5; 217:22; 228:17; 259:20;
unfortunately 22:9; 141:25; 150:BS 25512; 257~17; 258:19,20; Villeone 107:4
263:12; 268:21; 270:10, 268:12
4614; 56:20; 75:23; 275~2: update 219:16 validation-but 157:19 Virginia 122:20
14; 287:24; 292:23
uniform 157:16 updates 219:s validity 26:20; 241:lO virtual 87:4,8
useful 20:16; 59:19;
uniformly 235:24 upfront 181:9 65:10;86:16; 112:21; value 23:lO; 27:6; 53:17; virtually 569; 100:3;
unilateral 57:2,12,13; upgrading 265:4 120:14; 151:24; 154:21; 54:15; 67:9; 72:23; 80:s; 183:4
58:lO upon 5:17; 10:8; 116:19, 166:2,8; 173:18; 177:2,8; 139:16; 147:13; 162:14; visibility 12O:lO
unilaterally 58:9 20,24; 123:7; 12610; 188:24; 203:3,11; 224~24; 164:3,21; 177:8; 183:18, visible 37:20; 96:25;
unintended 138:5,5,24 159:23; 226:lS; 234:8,10; 225:21; 228:11,16; 230:5; I 22; 198:3; 235:6,7,20; 97:2,3,4,4; 108:10; llO:$

typo - visible (32) Min-U-Script@ Miller Reporting Company (202) 546-666t


.
Nonclinicd Studies Subcommittee of the Hearing
Advisory Committee for Pharmaceutical Science December 14,1999
vision 153:14,15; 22213 150~10; 162:lO; 167:14, 149:21; 153:20; 154:2; 158~25; 159:16; 183:23; yellow 15:7
visiting 117:2 21; 172:17,18; 173% 20; 185:15; 205:9; 239:12; 228:19; 234:13; 248:18; yield 160:7
177:8; 180~23; 181:15; 242:ll; 260119; 263:2; 253:13; 264~24; 279:13; yields 150:4
visualize 83:2; 262:20
194:17; 201:14; 203:12; 265:15; 279:12; 2868; 280:19; 281:ll; 292:ll;
visualized 83:3
Vital 200:12
vitro 366; 52:24; 53:22;
211:20;212:1,20; 223:3,
5,12; 230~14; 232:8;
287~21; 294~22
whole-animal 261:s
293:16; 295:12
workable 254:23 z
238:12; 240~15; 241:ll; whose 5:17; 156:3; worked 49:ll; 173:25;
97:13; 200:15; 249:l; 242~25; 243:5; 247:12,18; 17611 zero 30:25
233: 17
261:17,17; 28624 251:7; 254:5; 255:16; wide 184:2; 193:6 ziprasidone 54:23; 55:15
working 20:6; 21:10,17;
vivo 12:15; 33:6; 52:25, 256:9,12,20; 258~20; widely 199:7,8 zoom 10625
34:2; 69:6; 74:8; 9621;
25,25,25; 53:22; 54:6; 264:17; 268:13,15; 270:2;
wider 14:16; 250:16 98:11,14; 105:6; 106:19;
82:1;83:13;84:15,15; 278:20; 287~19; 293:4;
widespread 4:25 118~21; 129:14; 145:21;
90:6,7,15;91:8;92:12, 294:5
Willebrand 174:7,10,13, 210~10; 218:24; 240:23,
21; 97:12; 1OO:S;1163; way-they l34:3
15,lS 24; 241:ll; 281:14; 287~6;
117:15; 167:21; 234:9; WAY-10635 74:lO
willing 18620; 283:13 294:20,20; 295:25
261:16
ways 12:ll; 14:15; 15:20, works 44:21; 95:22
voice 121:ll WIN-35,428 55:21; 56:5;
23,25; 25:24; 46321; workshops 21:20
voicing 295:21 57:7
47:10;74:10; 111:18;
volts 54:3 122:25; 125:23; 179:ll; win/win 27:7; 38:5 j workstation 106:ll
volume 94:20,21,23; 181:2; 188:24; 1195:25; Wind 128:3 world 92:25; 95:22;
96:1,2,12,15; 109:lS; 197:12; 236~13; 237:17, window 40:2 112:17; 118:21; 121:15;
171:9,12,13; 175:2,4,11 19; 275:15; 279:lO; wisdom 221:6; 239:14; 134:5; 275:23; 278~4;
volume-rendered 282:15;283:11;291:13 240:s; 263: 16; 264:5 295: 10
10613 wayside 78: 1 wish 5:17; 158~25; worlds 241:13; 253:19
vohJmes 96:14 weak 88:19; 247:lS 223~24; 224~1; 246~8 worn 69:23
volumetric 94:17; 96:23 weaker 115:19,21 withdraw 60: 19 worried 124:l
volumetrically 95:7 wear 40:25 withdrawals 154:23 worry 124:l
volunteer 42:9; 43:5; weave 134:24 withdrawn 145:15 worst 165:16; 173:4
272~9; 281:9,22,23 web 71:8; 97:l; 110:9,14, within 14:12,13; 16:25; worth 44:12; 111:21;
volunteer’s 44:2 17; 112:24; 122:25; 123:3; 17:5; 19:s; 27~22; 31:5; 112:15; 124:19; 209:19;
volunteers 188:16; 126~23; 127:10,12,18,19; 42:6; 64:13; 69:18; 73:13; 261:24
272~20; 274:1,4 153:4 769; 87:4; 97:17; 98:4; wrestle 107:19
von 174:7,10,13,15,18 web-based 108:12; 112:24; 118:3,7; 122:9; wrestling 126:25
110:4 132:8,12; 139:19; 160:1;
vote 286: 19 168:13,20; 172:8,22; write72:ll
voted 2924 Webster 108:3 177:5; 185:2; 187:21; written 5:6; 19O:l
voxel94:20,22; 95:2 weeks 69:18; P56:l; 189:6; 194:22; 196:13; wrong 61:9; 85~24;
2OO:lS; 277~6 197:11;201:11,11;202:7; 284:17; 293:7
weight 139:3; 142:14;
W 152:19; 153:23; 175:7;
208:lO; 222:4,11,13;
233:13; 243:14; 246:13;
wrong-it 284:ll
wrote 189:17; 242:19
194:19 247~20;285: 12
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waiting 46:19 well-if 219:ll 36:4; 103:25; 104:3;
waiver 5:3,5 well-known 159:7 168:24; 232:9; 240:5,25; x 55:3
252:2; 280:6,6; 283:12;
want-how 253:21 were-it 292:l xenobiotics 32:20; 37:25
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wonder 76:5; 98:15;
286:13 whatsoever 234:l 174: 19 Y
warrant 7:14 whereas 50~6; 75:3; wondered 224~24
warranted 72:20 88:12; 128:22; 161:22;
wonderful 35:25; 84:12; y 55:5
washed GO:23 170:8; 234:8
95~25; 9621; 97:18,20; year 70:3; 73:13,19,19,
waste 163:4 whereby 125:lS; 159:15, 102:20; 122:25,25 21; 112:22; 156:12,20;
water 83:21,22,22; 84:3; 17; 260:14 219:2; 25623; 26212
wondering 133:3;
100:20; 102:13; 108:16 Whersupon 135:3; 227~20; 283:14; 296:9 years 17:16; 19:23;
waters 7214 296:22 word 50:21; 81:17; 23:14; 31:24; 41:17;
wave 25:8 wherever 256:23 107:16; 1466; 157:18; 4618; 54:11,14;69:17;
waves 25:ll which-l 231:20 196~21; 198:20,21; 80:7; 81:11,23,24; 89:3;
white 34:19; 42:23 264:ll 92:25; 96:22; 97:16;
way 8:5; 10:25; 16:24;
whiz 118:18; 119:6; words 27:9; 35:13; 71:24 100:14; 112:3; 113:10,11;
18:ll; 21:6; 27:4; 28:6;
29:1,20,22; 30:10,18; 120:19; 121:14; 125:14; work 11:13; 20:15; 23~10; 114: 10, 10,13; 120:7;
126:4; 22217 44:23; 46:4,15; 47:ll; 121:s; 122:lS; 123:19,23;
33:5,23; 34:12,14; 35:2;
whole 7:25; 12:16,20; 49:9; 50:2,10; 68:5; 75:9; 126:9,11; 142:11,16;
56:25; 59:5,23;71:14;
14:3; 15:10,21; 24:14; 82:14; 91:22; 93:20; 174:l; 185:17; 203:4,7;
-. 74:25; 75:3,24; 85:13;
95:11,21,23,24; 96:9,20; 205:5; 218:18; 265:13;
86:25; 112:3; 114:8; 28:7; 56:l; 83:14; 91:lo;
94:25; 95:21; 1064; 97:14;99:13; 102:22; 270:1,22; 279:22; 287~14
123:16; 129:ll; 130:9;
131:20; 133:19; 138:5; 110:9,15; 111:20; 128:3; 104:11; 107:3; 115:2; years-it 147:17
145:4; 147:23; 148:24; I 132:4,9; 137:14; 143:19; 119:17; 120:22; 122:s; I years-you 257:14 I

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