Osmania University Syllabus for M.

Pharmacy (Pharmacology)
(w.e.f. academic year 2009-10)

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Scheme of Instruction and Evaluation for M. harmacy ( harmacolo!y) I " Semester " #evised-2009
Su$%ect &ode Su$%ect ' a(er )heory ' ractical Instruction *ours (er wee+ Evaluation ,uration of E-ternal E-amination ractica Interna l l /* E-terna l .

)heory M.PCOL. .).)*) Pharmaceutical Analytical echni+ues &rug &esign an1 Molecular Pharmacology (ioassays an1 Screening Metho1s Princi2les of o3icology Pharmaceutical Analytical echni+ues (ioassays an1 Screening Metho1s Scientific an1 echnical 6riting (SA7L) Seminar heory , ----5 5 .*

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Scheme of Instruction and Evaluation for M. harmacy ( harmacolo!y) II" Semester " #evised-2009
Su$%ect &ode Su$%ect ' a(er )heory ' ractical Instruction *ours (er wee+ Evaluation ,uration of E-ternal E-amination ractica Interna l l /* E-terna l .

)heory M.PCOL. .).0*) 7ntellectual 2ro2erty rights : 'egulatory affairs A1vances in Pharmacology (io2harmaceutic s an1 Pharmaco;inetics Pharmacology : Pharmaco thera2eutics heory , ----.*

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M.PCOL.P.).0*4 M.PCOL.P.).0*5 M.PCOL. .).0*/ M.PCOL.).0*9

A1vances in Pharmacology Practicals. (io2harmaceutic s an1 Pharmaco;inetics "ntre2reneurshi2 Management (SA7L) Seminar

Practical Practical utorial heory

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SA7L< Self assess 7nstrumentation Learning

Scheme of Instruction and Evaluation for M. harmacy ( harmacolo!y) Semester III and I. ,ISSE#)/)I01 " Original research =or; carrie1 out by the can1i1ate un1er the gui1ance of regular teaching faculty8visiting faculty of the 1e2artment shoul1 be submitte1 in a boun1 form. "valuation of the 1issertation shall be 1one by e3ternal an1 internal e3aminers a22ointe1 by the university. &issertation viva-voce %ra1e A8(8C8&8F &issertation re2ort %ra1e A8(8C8&8F A. "3cellent (. >ery goo1 C. %oo1 &. Fair F. Fail

*/#M/&E2)I&/3 /1/34)I&/3 )E&*1I52ES Su$%ect &ode6 M. &03.).1.101 Sessional < .* Perio1 8 6ee;< , "3aminations < /* $ature of "3am< heory &uration of "3am < . hrs 21I) " I a) 2.-.isi$le S(ectrosco(y< (asic 2rinci2les? interaction of electromagnetic ra1iation =ith matter an1 its effects (electronic transitions). Conce2t of chromo2hore an1 au3ochrome? effect of con@ugation? solvent an1 2#. 7nstrumentation (com2onents an1 their significance). Absor2tion s2ectra of organic com2oun1s an1 com2le3es illustrating the 2henomenon an1 its utiliAation in +ualitative an1 +uantitative stu1ies of 1rugs inclu1ing multicom2onent analysis. 6oo1=ar1-Fieser rules for calculating absor2tion ma3imum for unsaturate1 hy1rocarbons. &ifference an1 1erivative s2ectra. $) Infra-#ed S(ectrosco(y< 7nteraction of infrare1 ra1iation =ith organic molecules an1 itBs effects on bon1s. 7nstrumentation- &is2ersive 7' s2ectro2hotometers an1 Fourier transform s2ectro2hotometers. Sam2le han1ling for 7' s2ectrosco2y. 7nter2retation of 7' s2ectra. (rief note on A '. (Attenuate1 otal 'eflectance). 21I) " II 1uclear Ma!netic #esonance S(ectrosco(y< Fun1amental 2rinci2les of $M'? instrumentation (com2onents an1 their significance). Chemical shifts conce2t? s2in- s2in cou2ling? s2in-s2in 1ecou2ling? shiel1ing an1 1eshiel1ing? solvents. signal multi2licity 2henomena in high resolution PM'. 7nter2retation of PM' s2ectra. (rief intro1uction about Carbon-). $M' an1 0& $M' S2ectrosco2y. 21I) " III Mass S(ectrometry< (asic 2rinci2les an1 instrumentation (com2onents an1 their significance). 7oniAation techni+ues? mass s2ectrum an1 its characteristics? molecular ion? metastable ions? fragment ionsC fragmentation 2rocesses? fragmentation 2atterns an1 fragment characteristics in relation to 2arent structure an1 functional grou2s. 'elative abun1ances of isoto2es an1 their contribution to characteristic 2ea;s. 21I) " I. &hromato!ra(hic )echni7ues< Classification of chromatogra2hic metho1s base1 on mechanism of se2aration an1 their basic 2rinci2les. 8as chromato!ra(hy< 7nstrumentation? column efficiency 2arameters? 1erivatisation metho1s? a22lications in 2harmaceutical analysis. 3i7uid chromato!ra(hy< Com2arison of %C an1 #PLC? instrumentation in #PLC? normal an1 reverse1 2hase 2ac;ing materials? column selection? mobile 2hase selection? efficiency 2arameters? a22lications in 2harmaceutical analysis. 7nstrumentation an1 a22lications of #P LC? ion e3change chromatogra2hy? gel 2ermeation chromatogra2hy? chiral chromatogra2hy? flash chromatogra2hy? an1 su2ercritical flui1 chromatogra2hy (SFC). 21I) " . Electro(horesis< Princi2les? instrumentation an1 a22lications of moving boun1ary electro2horesis? Aone electro2horesis (D")? isotach2horesis? isoelectric focusing (7"F)? continuous electro2horesis (2re2arative) an1 ca2illary electro2horesis. S&S gel electro2horesis an1 blotting techni+ues. #adio immunoassay and E3IS/6 Princi2le? instrumentation? a22lications an1 limitations.

#ecommended $oo+s ) 0 . , 4 5 / 9 H ). S;oog? &A? #oller? FE? Crouch? S'. Princi2les of instrumental analysis. 5 th e1.? (aba (ar;ha $ath 2rinters? #aryana? 0**/. 0. Silverstein? 'M? 6ebstar? FF. S2ectrometric i1entification of organic com2oun1s. 5 th e1.? Eohn 6iley : Sons (Asia) Pvt. Lt1.? Singa2ore? 0**4. .. 6illiam Gem2. Organic s2ectrosco2y? .r1 e1.? Palgrave? $e= !or;? 0**5. ,. Eag Mohan? Organic s2ectrosco2y< Princi2les an1 A22lications? 0 nd e1.? $arosa 2ublishing house Pvt Lt1.? $e= &elhi? 0**4. 4. Conners GA. A e3t boo; of 2harmaceutical analysis? . rd e1.? Eohn 6iley : Sons? Singa2ore? 0**,. 5. 6illar1 ##? Merritt LL? &ean EA? Settle FA. 7nstrumental metho1s of analysis? / th e1.? C(S Publishers : &istributors? $e= &elhi? )H95. /. Pavia &L? Lam2man %M? GriA %S? >yvyan EA. 7ntro1uction to s2ectrosco2y. ,th e1.? (roo;escole 2ublishers? California? 0**9. 9. Sharma (G. 7nstrumental metho1s of chemical analysis? 04 th "1.? %oel Publishing house? Meerut? 0**5. H. (ec;ett? A#? Stenla;e? E(. Practical 2harmaceutical chemistry? Part 7 : 77? ,th e1.? C(S Publishers : 1istributors? $e= &elhi? 0**,.

)* )*. "=ing? %6. 7nstrumental metho1s of chemical analysis? 4 th e1.? Mc%ra= #ill (oo; Com2any? $e= !or;? )H94. )) )). Schirmer? '". Mo1em metho1s of 2harmaceutical analysis? >ol. 7 : 77? 0n1 e1.? C'C Press? Flori1a? 0***. )0 )0. Moffat? AC? Osselton? MC? 6i11o2? (. Clar;eIs analysis of 1rugs an1 2oisons? >ol. 7 : 77? .r1 e1.? G.M. >arghese Com2any? Mumbai? 0**,.

,#28 ,ESI81 /1, M03E&23/# */#M/&03084 Sub@ect Co1e < M. &03 ).1.102 Sessional Perio1s86ee; < , "3amination < /* $ature of "3am < heory "3am &uration < . #rs 21I) "I Pharmaco;inetics a22roach to $e= &rug &iscovery (asic conce2ts an1 &efination? im2ortance of A&M" 2arameters in 1is2osition? thera2eutics an1 1evelo2ment their im2lication on 1rug 1iscovery. 21I)-II Overvie= on com2uter ai1e1 &rug 1esign (CA&&) inclu1ing JSA'? Combinational Chemistry? #igh hroughout screening (' S) 21I)-III Molecular (asis of &rugs Action< Cell signaling? communication bet=een cells an1 their environment? ion-channels? organiAations of signal trans1uction 2ath=ays? thir1 messengers? biosensors. &rug Latentiation <(asic conce2t? Pro1rugs of functional grou2s? (io-2recurssor 2ro1rugs? chemical 1elivery system. 21I) " I. (iotechnology in &rug &iscovery< Cloning of &$A? "32ression of clone1 &$A? Mani2ulation of &$A se+uence information? $e= (iological argets for &rug &evelo2ment $ovel &rug Screening strategies? $ovel (iological Agents? Antibo1ies? Antisense eligonucleoti1e thera2y? %ene thera2y. 21I) " . #erbal $eutracauticals as ne= source for me1icines. Stu1y of A1vance1 1rugs from natural sources of follo=ing grou2s< Anticancer? Anti A7&S? #e2ato2rotectives? Anti1iabetics? (rain oni cs? Anti urolithiates? Antifilarial? Antihy2erli2i1imics. Mo1ern 2hytochemical screening techni+ues an1 evaluation of herbal 1rugs an1 their e3tracts an1 formulations? Conce2t of 'everse Pharmacognosy. 9oo+s recommended ) 0 . , 4 ). Com2rehensive Me1icinal chemistry >ol-, "1.C. #anseh? Pergamon Press? $e= !or;. 0. Com2rehensive (iotechnology? "1. Murray Moo-!oung? Pergamon Press? $e= !or;. .. Com2rehensive (iotechnology information 2ublications (===.8nobi.nml.nih.gov ) ,. &e=ic; Paul M. Me1icinal $atural Pro1ucts-A (iosynthetic A22roach. :. Cha;ravarty .G. K #erbal O2tionsL. <.*

9I0/SS/4S /1, S&#EE1I18 ME)*0,S Sub@ect Co1e < M. &03 ).1.10; Perio1s86ee; < , "3amination < /* $ature of "3am < heory "3am &uration< . #rs Sessional < .*

21I) "I &rug 1iscovery 2rocess< Princi2les techni+ues an1 statergies use1 in ne= 1rug 1iscovery. #igh throughout screening. #uman genomies robotics an1 economics of 1rug 1iscovery? 'egulations? for laboratory animal care an1 ethical re+uirements. (ioassays < (asic 2rinci2les of bioassays official bioassays? e32erimental mo1els an1 statistical 1esigns em2loye1 in biological stan1ar1iAation. (iological stan1ar1iAation of vaccines an1 sera =ith certain e3am2les =ith reference to 7P. &evelo2ment of ne= bio assay metho1s. 21I) " II Preclinical mo1els em2loye1 in the screening of ne= 1rugs belonging to follo=ing categories. Antifertility agents? sym2athomimetics? 2arasym2athomimetics? muscle rela3ants (both central an1 2eri2heral). Se1atives? hy2notics? antiarrhythmic agents? car1iac stimulants? car1iotonic agents bronoho1ilators? antihistaminics? eicosanoi1s. Anti2sychotic agents? antian3iety agents nootro2ic 1rugs anti1e2ressant 1rugsC anti2ar;insonism agents? antic2ile2ticsC analgesics an1 anti-inflammatory agentsC antiulcer agentsC infarctionC antiatherosclerotic 1rugsC anti1iabeticsC mo1els for status e2ile2ticus 1rugs. cerebroventricular an1 other ne=er techni+ues of 1rug a1ministration an1 1evelo2mentC transgenic animals an1 other genetically 2rone animal mo1els. 21I) " III Alternatives to animal screening 2roce1ures? cell-line han1ling an1 maintenance an1 2ro2agation of cell lines? 2atch-clam2 techni+ue? in-vitro cell line base1 assays 1iabetics an1 arthraitis mo1els? molecular biology techni+ues. 21I) " I. Princi2les of to3icity evaluations? "&4*? L&4* an1 & values? 7nternational gui1elines (7C# "thics an1 animal e32erimentation recommen1ations).%ui1elines an1 regulatory agencies M CPCS"A?O"C&?F&A? F#SA?"PA?""C?6#O etc? 21I) " . 7ntro1uction to biostatistics? 2arametric an1 non-2arametric tests. 'egression an1 correlation< Linear regressions? Metho1 of least s+uaresC correlation coefficients? ran; correlation? multi2le regression ests of significance< testing hy2otheses? tests of significance base1 on normal 1istribution. t-testC significance of correlation coefficient. F-test an1 Analysis of >ariance< )-6ay? 0-6ay an1 .-=ay classification? Chi-s+uare test of (i) >ariance of a normal 2o2ulation (ii) %oo1ness of fit? (iii) 7n1e2en1ence in contingency tables. $on 2arametric tests? or1er statistics? sign test? run test? Me1ian test.

9oo+s recommended ) 0 . , 4 5 / 9 ). Pre M Clinical &rug &evelo2ment ? 'ogge 0. (asic an1 clinical Pharmacology? GatAung .. Pharmacological screening metho1s? $.S. Parmer an1 Shiv;umar ,. Pharmacological screening metho1s? $.S. Parmer an1 Shiv;umar 4. Calculations for Pharmaceutical Practice ? 6infiel1 <. Pharmacoe2i1emiology ? Storm /. CPCS"A? O"C&? F&A? 6#O? 7C# gui1elines from res2ective =ebsite 1o=nloa1s. 9. &rug 1iscovery an1 2harmacological evaluations? %.>ogel? S2ringer 2ublications.

9/SI& #I1&I 3ES 0= )0>I&03084 Sub@ect Co1e < M. &03 ).1.10? Sessional < .* Perio1s86ee; < , "3amination < /* $ature of "3am < heory "3am &uration < . #rs 2nit " I %eneral 2rinci2al of regulatory to3icology. Use of animals in 2reclinical to3icology stu1ies? role of 2reclinical to3icology in 1rug 1iscovery an1 1evelo2ment 2rocess. "32erimental consi1erations for assessing 2ossible human ris;. Flo= chart for 1evelo2ment of 2reclinical testing. &ose conversion factors? clinical signs to3icity. 2nit " II Single 1ose an1 re2eat 1ose to3icity stu1iesC Factors influencing such stu1ies such as s2ecies? se3? siAe? route ?1ose levelC &ata evaluation an1 regulatory re+uirements. &etermination of Ma3imum olerate1 &ose (M &) an1 L& 4* as 2er revise1 O"C& gui1elines. Allergenicity testing? 1ermal to3icity? immunoto3icology an1 in vitro metho1s of to3icology. 2nit " III 'e2ro1uctive to3icology assessment of male re2ro1uctive to3icity? s2ermatogenesisC 'is; assessment in male re2ro1uctive to3icityC Female re2ro1uctive to3icologyC Oocyte to3icityC alterations in re2ro1uctive en1ocrinologyC 'elationshi2 bet=een maternal an1 1evelo2mental to3icity. 2nit " I. MutagenicityC Mechanisms of mutagenesis? 2oint mutations?C 7n1ivi1ual chromosomes an1 com2lete genome mutations? germ cell mutations? somatic cell mutationC ests systems in vitro? chromosome 1amage an1 chromosomal aberration test? gene mutation? in vivo micronucleus tests in ro1ents? meta2hase analysis. 2nit " . Preclinical to3icological re+uirements for biologicals an1 biotechnological 2ro1uctsC safety analysisC 2roblems s2ecific to recombinant 2ro1ucts? to3ico;inetics? 2rinci2les of %LP as 2er O"C& gui1elines for con1ucting 2reclinical to3icity stu1ies 9oo+s recommened ) 0 . ). &rug safety "valuation? Shayne C %a1? 6iley 7nterscience 0. he to3icologistBs 2oc;et han1boo;? Michael E 1erelan;o 0n1 "1?0**9?C'C 2ress .. 'elevent O"C& gui1elines ( 7nternet resources) htt2<88===.ingentaconnect.com 8content8oec18)5*/.80**)8*******)8*******,

*/#M/&E2)I&/3 /1/34)I&/3 )E&*1I52ES ( #/&)I&/3) Su$%ect &ode 6 M. &03. .1.10: Sessional < .* Perio1 8 6ee;< 5 "3amination < /* $ature of "3am< Practical "3am &uration < 5 #rs 3ist of E-(eriments ) ). U>8>isible s2ectrum scanning of a fe= organic com2oun1s for U>- absor2tion an1 correlations of structures (4 com2oun1s) an1 isosbestic 2oint in case of mi3tures. 0 0. "ffect of solvents an1 2# on U> s2ectrum of 1rugs (0 e32eriments). . .. "stimation of multicom2onent formulation by U>- S2ectro2hotometer in formulations. (0 e32eriments). , ,. "32eriments base1 on the a22lication of 1erivative s2ectrosco2y. (0 e32eriments). 4 4. "32eriments base1 on #PLC (7socratic an1 %ra1ient elution) techni+ues. ) 0 . , (0 e32eriments). 5. 7nter2retation of 1rugs by 7' s2ectra. /. 6or;sho2 of s2ectrosco2y< (U>? 7'? $M'? MASS) structural eluci1ation of at least 4 com2oun1s (, e32eriments). 9. Se2aration of 2rotein 1rug substances by electro2horesis. H. Any other relevant e32eriments base1 on theory.

9I0/SS/4S /1, S&#EE1I18 ME)*0,S

Su$%ect &ode 6 M. &03 1.10< Sessional < .* Perio1s8=ee; < 5 "3amination < /* $ature of "3am< Practicals "3am &uration< 5 #rs 3ist of E-(eriments . ) ). (iological stan1ar1iAation of 1rugs li;e acetylcholine8#istamine 0 0. "32eriments on C$S. %eneral screening metho1s of 1rugs on C$S C$S stimulants an1 1e2ressants? an3iogenics an1 an3iolytics? amnestics an1 nootro2ics? anti convulsants? analgesics? safety 2harmacology. .. &rugs acting on %astrointestinal tract %eneral screening metho1s for the anti ulcer activity? intestinal motility? an1 anti-1iarrhoeals. ,. "32eriments on C>S %eneral screening 2roce1ure of anti-arrhythmic agents? anti-hy2ertensives? anti-ischemics. ) 4. "32eriments on Local anesthetics %eneral metho1s for evaluating local anesthetic activity 5. "32eriments on %eneral Pharmacology "nAyme in1uction activity? 1rug 1e2en1ence an1 =ith1ra=l effects. /. "32eriments on &iueretics %eneral screening metho1s for evaluating the 1iuretic activity. 9. Screening 2roce1ure for anti1iabetic 1rugs. H. "32eriments on analgesic an1 anti-inflammatory agents %eneral metho1s of screening for the evaluation of analgesics an1 anti inflammatory agents? Nboth acute an1 chronic mo1elsO )*. %eneral metho1s for evaluating the antimicrobial activities of chemothera2eutic agents. )). "stimation of biochemical an1 free ra1ical scavengers. #ecommended $oo+s ) 0 . ). #an1 boo; of "32erimental Pharmacology S.G.Gul;arni 0. #an1 boo; of laboratory animal science? Animal mo1els? Eann #au? 0n1 e1ition vol 0? 0**0. .. #an1 boo; of Laboratory Animal Science< Selection an1 #an1ling of Animals in (iome1ical research< v )? Per Sven1sen? Eann #au? )HH,

S&IE1)I=I& /1, )E&*1I&/3 @#I)I18 Su$%ect &ode 6 M. &03 ) 1.10A Sessional < 4* Perio1s8=ee; < 0 "3amination < --

$ature of "3am < utorials

"3am &uration< --

&ourse 0$%ectives o be able to a22reciate an1 un1erstan1 im2ortance of =riting scientifically. ) P o &evelo2 com2etence in =riting an1 abstracting s;ills. 0 P o =rite either a 1raft research 2ro2osal or a cha2ter of 1issertation. 21I) " I &033E&)I01 /1, E./32/)I01 0= I1=0#M/)I01 71entification sources? searching information? classifying information un1er fact8o2inion? tabulating information? summariAing a te3t an1 2resenting se+uence of to2ics in 1ifferent forms. 21I) " II @#I)I18 /S / ME/1S 0= &0MM21I&/)I01 - &ifferent forms of scientific an1 technical =riting. - Articles in @ournals? 'esearch notes an1 re2orts? 'evie= articles? Monogra2hs? &issertations? (ibliogra2hies. #o= to formulate outlines< he reasons for 2re2aring outlines ) (i) as a gui1e for 2lan of =riting (ii) as s;eleton for the manuscri2t Gin1s of outline< to2ic outlines? conce2tual outline? sentence outlines an1 combination of to2ic an1 sentence outlines 21I) " III ,#/=)I18 )I)3ESB S29 )I)3ESB )/93ESB I332S)#/)I01S - ables as systematic means of 2resenting 1ata in ro=s an1 columns an1 luci1 =ay of in1icating relationshi2s an1 results. - Formatting ables< itle? (o1y stab? Stab Column? Column #ea1? S2anner #ea1? (o3 #ea1 - A22en1ices< use an1 gui1elines he 6riting 2rocess< %etting starte1? Use outline as a starting 1evice? &rafting? 'eflecting an1 'e-rea1ing Chec;ing< OrganiAation? #ea1ings? Content? Clarity an1 %rammar (revity an1 Precision in =riting - &rafting an1 'e-1rafting base1 on critical evaluation 21I) " I. /#)S 0= ,ISSE#)/)I01'#ESE/#&* #E 0#)'/#)I&3E 7ntro1uction? 'evie= of Literature? Metho1ology? 'esults an1 &iscussion As; +uestions relate1 to< content? continuity? clarify? vali1ity internal consistency an1 ob@ectivity 1uring =riting each of the above 2arts. 21I) " . @#I)I18 =0# 8#/1)S Clearly state the +uestion to be a11resse1C 'ationale an1 im2ortance of the +uestion being a11ressC "m2erial an1 theoretical conce2tualiAationC Presenting 2ilot stu1y81ataC 'esearch 2ro2osal of metho1C Clarity? s2ecificity of metho1C Clear organiAationC Outcome of stu1y an1 its im2licationsC (u1getingC Available infra-structure an1 recourses an1 "3ecutive summary

#eferences

). APA ()H9,)< Publication Manual of Americal Psychological Association .r1 "1? 6ashington. 0. Coo2er? #.M. ()HH*)< 7ntegrating 'esearch< A %ui1e for Literature 'evie=s (0n1 "1ition). California< Sage. . .. &unn? F.> : Others.("1.) ()H9,)< &isserninating 'esearch< Changing Practice. $!<Sage. ) 0

I1)E33E&)2/3 #0 E#)4 #I8*)S C #E823/)0#4 /==/I#S Su$%ect &ode 6 M. &03 ) 1.201 Sessional < .* Perio1s8=ee; < 5 "3amination < /* $ature of "3am< heory "3am &uration< . #rs

21I) " I Conce2ts of total +uality management? goo1 laboratory 2ractices an1 7SO. Juality assurance : Juality control for active 2harmaceutical ingre1ients (AP7s) an1 other interme1iates in 2rocess an1 finishe1 2ro1ucts. %MP for bul; 1rugs an1 formulations. 21I) " II >ali1ation of 2rocess? e+ui2ment? 2roce1ures? vali1ation master 2lans. &ocumentation< Master 'ecor1s M Manufacture? analysis of ra= materials : finishe1 2ro1ucts. (atch 'ecor1s - Manufacture : Analysis of ra= materials : finishe1 2ro1ucts. 'egulatory com2liance recor1s? &istribution recor1s? &rug recall registers? management revie= recor1s etc. 21I) " III 'egulatory acts< An un1erstan1ing of the &rugs : cosmetics Act )H,* : rules )H,4? - =ith s2ecial relevance to sche1ule M? Sche1ule U? Sche1ule !? latest 1rug 2rice control or1er? latest 2harmaceutical 2olicy 8 1rug 2olicy. 21I) " I. US 'egulatory 2ractices< USF&A a22rovals? 6#O M %MP? certification 2roce1ures? 7C# gui1elines. 21I) " . 7n1ian Patent Act as amen1e1 u2 to 1ate =ith reference to 1rugs an1 7ntellectual 2ro2erty rights? =orl1 tra1e OrganiAation? filing a 2atent un1er 7n1ian 2atent Act? Filing 7nternational 2atent? 7nfringement of 2atentC &oha &eclaration? ra1e 'elate1 7ntellectual Pro2erty rights. ( '7PS).Patent search? 2atent challenging an1 2ara 7> filing

Recommended Books ). 0. .. ,. 4. 5. &rugs : Cosmetics Act )H,* by >i@ay Mali;. &rugs La=s by #ussain. 7n1ian 2atent Act. Juality assurance : %LP by !. An@aneyulu. Juality control : A22lication by (entran1 L. #anser. Juality assurance in Analytical chemistry by 6erner Fun;.

/,./1&ES I1 */#M/&03084 Su$%ect &ode 6 M. &03 ) 1.202 Sessional < .* Perio1s8=ee; < 5 "3amination < /* $ature of "3am< heory "3am &uration< . #rs

21I) "I 'ece2tor Pharmacology %eneral as2ects of rece2tor 2harmacology?structural an1 functional as2ects of rece2tor s? regulation of rece2tors?isolation?classification an1 characteriAation of rece2tors. 21I) " II $eurotransmission Pharmacology %eneral as2ects an1 ste2s involove1 in neurotransmission $eurohumoral transimission in autonomic nervous system. $eurohumoral transmission in central nervous system $on-a1renergic non-cholinergic transmission N$A$CO. 21I) " III A 1etaile1 stu1y of the mechanism of action? 2harmacology of 1rugs use1 in A$S-Parasym2athomimetics an1 lytics? sym2athomimetics an1 lytics? agents acting at neuromuscular @unction an1 ganglia. C$S- %eneral anaesthetics? se1atives? hy2notics. &rugs use1 to treat an3iety? 1e2ression? 2sychosis? mania?e2ile2sy? neuro1egenerative 1eseases? 1rug 1e2en1ence an1 a11iction. C>S- 1iuretics? anti ischemics? antihy2ertensives? antiarrythmics? 1rugs for heart failure an1 1ysli2ieiemia. 21I) " I. A 1etaile1 stu1y of the mechanism of action? 2harmacology of 1rugs use1 in Autocoi1 2harmacology- a stu1y of the mechanisms involve1 in the formation? release? 2harmacological actions an1 2ossible 2hysiological role of histamine?serotinine?;inins?2rostaglan1ins?o2ioi1autocoi1s an1 cyclic .B M 4B AMP. Systemic 2harmacology of 1rugs acting as agonists an1 antagonists to the autocoi1s. %7 Pharmacology M anti ulcer?2ro;inetics?antiemetics? anti1iarrhoeal an1 1rugs for consti2ation an1 irritable bo=el syn1rome. #ormone an1 hormone antagonists.Anti biotics an1 chemothera2eutic agents. Analgesics an1 anti-inflammatory agents. 21I) " . F'"" 'A&7CAL A$& 7MMU$O P#A'MACOLO%! %eneration of free ra1icals? role of free ra1icals in etio2athology of various 1iseases? 2rotective activity of certain im2ortant antio3i1ants. Cell an1 biochemical me1iators involve1 in allergy? immunomo1ulation an1 inflammation. Classification of hy2ersensitivity reactions an1 1iseases involve1. hera2eutic agents for allergy? asthma? COP& an1 other immunological 1iseases =ith em2hasis on immunomo1ulators.

#ecommemded $oo+s ) 0 . , ). Clinical Pharmacology by &.'.La=rnce an1 P.$.(ennette 0. Pharmacology an1 Pharmacothera2eutics '.S. Satos;ar an1 S.&. (han1ar;ar. .. he Pharmacology basis of thera2eutics. )*th e1ition by Louis S.%oo1man an1 Altre1 %illman ,. Pharmacology by #.P. 'ang an1 M.A. &ale

4 5 / 9 H

4. (io2harmaceutics an1 Pharmaco;inetics an1 intro1uction by ". $otary 5. &rug Metabolism by (erhar1 ests an1 Peter Eenner. /. Princi2les of &rug action by %ol1stein? Arano= an1 Golman. 9. Pharmaco;inetics < 'egularory 7n1ustrial Aca1emic Pers2ectives? Secon1 "1ition? e1ite1 by Peter %.6elling an1 Francis L.S. se H. he &rug &evelo2ment Process< 7ncreasing "fficiency an1 cost "ffectiveness? e1ite1 by Peter %.6elling? louis Lasagna an1 Umesh >. (ana;ar

)*. Pharmaceutical Practice ? 6in fiel1

9I0 */#M/&E2)I&S /1, */#M/&0DI1E)I&S Su$%ect &ode 6 M. &03.).1.20; Sessional Perio1 8 6ee;< , "3aminations < /* $ature of "3am< heory &uration of "3am< . hrs 21I) -1 < .*

9ioavaila$ility and 9io7uiovalence6 Ob@ectives? bioavailability : variations? measurements of bioavailability? enhancing bioavailability? conce2ts of e+uivalents? official bioe+uivalence 2rotocols : thera2eutic e+uivalence. 21I) -2 ,ru! /$sor(tion6 %eneral consi1eration? absor2tion 8 1rug trans2ort mechanisms? role factors affecting absor2tion? absor2tion of 1rug non-2eroral routes? metho1s of 1etermining absor2tion-in-vitro? in-situ? an1 in-vivo metho1s. ,ru! ,istri$ution6 Factors affecting? 2rotein : tissue bin1ing? ;inetics? 1etermination of rate constants : 1ifferent 2lots (1irect? Scatchar1? : reci2rocal). 21I) -; harmaco+inetcs6 Parameters : 1etermination? 2harmaco;inetic mo1els M one com2artment? multi com2artment in 7> bolus? 7> infusion : e3tra vascular? 1rug : metabolites levels in bloo1? urine an1 other biological flui1s. 7ntegration of ;inetics. A22lication of 2harmaco;inetics in ne= 1rug 1evelo2ment? 1esign of 1osage forms an1 novel 1rug 1elivery systems. 21I) - ? ,ru! ,is(osition and E-cretion6 (iotransformation? factors affecting biotrasformation? Phase 7 : Phase-77 reactions. &learance6 Conce2t? renal? non-renal clearance? mechanism? 1etermination? Q 1rug metaboliAe1? 1ifferent volume of 1istribution. 21I) " : harmaco+inetics of Multi(le ,osin!6 >arious terminology? 1etermination? a1@ustment of 1osage in renal : he2atic im2airment? in1ivi1ualiAation of thera2y? thera2eutic 1rug monitoring. 1on-linear +inetics6 Cause of non-linearity? estimation of various 2arameters? bioavailability of 1rugs that follo= non-linear ;inetics. Chrono2harmaco;inetics : 2harmaco;inetics of el1erly an1 infants. #ecommended $oo+s ). (io2harmaceutics an1 Clinical Pharmaco;inetics? Mile %ibal1i? Lea an1 Febriger? Phila1el2hia. 0. Current conce2ts in Pharmaceutical Sciences? S=arbric;? Lea an1 Febriger? Phila1el2hia. .. heory : Practice of 7n1ustrial Pharmacy? L.Lachman? >arghese Publ? (ombay. ,. Clinical Pharmaco;inetics? 'o=lan1 an1 oAer? Lea an1 Febriger? Phila1el2hia. 4. (io2harmaceutics an1 Clinical Pharmaco;inetics? $iaAi? Prentice #all? Lon1on. 5. 'emingtons Pharmaceutical Sciences? Mac; : Co. /. (io2harmaceutics : Clinical Pharmaco;inetics? &M (rahman;ar? >allabh? &elhi. 9. C.>.S.Subrahmanyam? e3tboo; of (io2harmaceutics an1 Pharmaco;inetics? 0**H? >allabh Pra;ashan? &elhi.

*/#M/&03084 C */#M/&0 )*E#/ E2)I&S Su$%ect &ode 6 M. &03 ).1.20? Perio1s86ee; < , "3amination < /* $ature of "3am < heory "3am &uration < . #rs 21I) "I Sessional < .*

Princi2les of Pharmaco;inetics. ) 0 A. 'evision of (asic conce2ts. (. Clinical Pharmaco;inetics. * ). &ose M res2onse in man ) 0. 7nfluence of renal an1 he2atic 1isease on Pharmaco;inetics 0 .. hera2eutics 1rug monitoring . ,. Po2ulation Pharmaco;inetics.

21I) " II (asics in clinical 2harmacology Clinical trials of 1rugs?1esign of clinical trials hera2eutic 1rug monitoring an1 critieria for &M. A1verse &rug 'eactions? &rug 7nteractions an1 A&' monitoring. 21I) " III Patho2hysiology an1 1rug thera2y of the follo=ing 1isor1ers. SchiAo2hrenia? an3iety? 1e2ression? e2ile2sy? Par;insonBs AlAheimerBs 1iseases Migraine hy2ertension? angina 2ectoris? arrhythmias? atherosclerosis? myocar1ial infraction? (? le2rosy? leu;emia? soli1 tumors? lym2homas? 2soriasis? res2iratory? urinary ? g.i. tract infections? en1ocar1itic? fungal an1 #7> infection? rheumatoi1 arthritis? glaucoma? menstrual 1isor1ers? meno2ause. 21I) " I. &rug thera2y an1 Pharmaco;inetics in ) a. %eriatrics 0 b. Pe1iatrics . c. Pregnancy : Lactation. 21I) - . Pharmacogenetics< #istorical as2ects of 2harmacogenetics? biomar;ers? inter-racial an1 in1ivi1ual variability in 1rugs metabolism.? rece2tors .'ole of 1rug trans2orters? interethnic 1ifferences? clinical vie= 2oints an1 future 2ers2ectives? stem cell M a ne= thera2eutic a22roach. %ene thera2y? Pharmacovigilance conce2ts an1 its im2act.

#ecommended 9oo+s ) 0 . , ). (io2harmaceutics an1 Pharmaco;inetics? >en;atesh=arlu 0. Clinical Pharmacy an1 thera2eutics ? #erfin1al .. &rug &is2osition an1 Pharmaco;inetics ? #.Curry ,. Pharmaco;inetics ?Milo %ibal1i

4 5 / 9 H )* ))

4. Managing clinical &rug 1evelo2ment ? Cocchetto 5. Pharmacogenomics ? Galo= /. &urg 1iscovery an1 1evelo2ment? 'ang 9. (asic Statistics an1 Pharmaceutical Statistical a22lications ? Muth H. Pharmaco;inetics for the Pharmaceutical Scientist ? 6agner )*. 6.#.O Publications ? echnical 'e2ort Series. )). Clinical Pharmacology by &.'.La=rnce an1 P.$.(ennette

/,./1&ES I1 */#M/&03084 #/&)I&/3S Su$%ect &ode 6 M. &03 .1.20: Sessional < .* Perio1s8=ee; < 5 "3amination < /* $ature of "3am< Practicals "3am &uration< 5 #rs

3ist of E-(eriments. Minimum E e-(eriments shall $e conducted. ) ). "32eriments for stu1ying the effects of the more im2ortant biogenic agents li;e histamine? acetylcholine? 4# ? o3ytocin an1 their effect in the 2resence of antagonist on suitable isolate1 tissue 2re2arations. 0 0. "stimation of PA0 values of various antagonists un1er suitable isolate1 tissue 2re2arations. . .. "32eriments on C>S- effect of various 1rugs on isolate1 heart 2re2arations on various animal mo1els un1er normal arrhythmic an1 hy2o 1ynamic con1itions. , ,. &rugs acting on %astro intestinal tract. o stu1y the 1rug activity on oeso2hagal motility. 4 4. Monitoring of 1rug concentrations in saliva8urine8bloo1. 5 5. Action of C$S stimulants an1 1e2ressants using suitable e32erimental mo1el. / /. "valuation of anti1e2ressant an1 anti an3iety 1rugs. 9 9. &rug absor2tion an1 elimination stu1ies. H H. Any other e32eriment base1 on the to2ics mentione1 in theory? )* )*. >irtual an1 stimulate1 e32eriments are 2ermitte1.

9I0 */#M/&E2)I&S /1, */#M/&0DI1E)I&S Su$%ect &ode 6 M. &03. .1.20< Perio1 8 6ee;< 5 "3aminations Sessional < /* < .*

$ature of "3am< Practicals

&uration of "3am< 5 hrs

Su!!ested e-(eriments ). Com2arative 1issolution stu1ies on 1ifferent 1osage forms for 1rugs. 0. "ffect of 2# 8 2article siAe on 1issolution stu1ies. .. Plasma 2rotein bin1ing stu1ies on 1ifferent 1rugs. ,. "stimation of 2harmaco;inetic 2arameters in urine 8 serum sam2les. 4. "stimation of creatinine clearance. 5. "stimation of 2harmaco;inetic 2arameters for the given urinary e3cretion 1ata. /. "stimation of 2harmaco;inetic 2arameters for the given oral absor2tion 1ata.

E1)#E #E1E2#S*I M/1/8EME1) Su$%ect &ode 6 M. &03 ) 1.20A Sessional < 4* Perio1s8=ee; < 0 "3amination < -$ature of "3am< utorials "3am &uration< -&ourse 0$%ectives6 ) P o 2rovi1e conce2tual in2uts regar1ing entre2reneurshi2 management.

0 . ,

P o sensitiAe an1 motivate the stu1ents to=ar1s entre2reneurshi2 management. P o orient an1 im2art ;no=le1ge to=ar1s i1entifying an1 im2lementing entre2reneurshi2 o22ortunities. P o 1evelo2 management s;ills for entre2reneurshi2 management.

21I) " I6 &01&E )2/3 =#/ME @0#D ) - Conce2t nee1 an1 2rocess in entre2reneurshi2 1evelo2ment. 0 - 'ole of enter2rise in national an1 global economy . - y2es of enter2rise M Merits an1 &emerits , - %overnment 2olicies an1 schemes for enter2rise 1evelo2ment 4 - 7nstitutional su22ort in enter2rise 1evelo2ment an1 management 21I) " II6 )*E E1)#E #E1E2# ) - "ntre2reneurial motivation M 1ynamics of motivation. 0 - "ntre2reneurial com2etency M Conce2ts. . - &evelo2ing "ntre2reneurial com2etencies - re+uirements an1 un1erstan1ing the 2rocess of entre2reneurshi2 1evelo2ment? self a=areness? inter2ersonal s;ills? creativity? assertiveness? achievement? factors affecting entre2reneurIB role. 21I) " III6 3/21&*I18 /1, 0#8/1ISI18 /1 E1)E# #ISE ) - "nvironment scanning M 7nformation? sources? schemes of assistance? 2roblems. 0 - "nter2rise selection? mar;et assessment? enter2rise feasibility stu1y? S6O Analysis. . - 'esource mobiliAation - finance? technology? ra= material? site an1 man2o=er. , - Costing an1 mar;eting management an1 +uality control. 4 - Fee1bac;? monitoring an1 evaluation. 21I) " I.6 8#0@)* S)#/)E8IES /1, 1E)@0#DI18 ) - Performance a22raisal an1 assessment 0 - Profitability an1 control measures? 1eman1s an1 challenges . - $ee1 for 1iversification , - Future %ro=th M echni+ues of e32ansion an1 1iversification? vision strategies 4 - Conce2t an1 1ynamics 5 - Metho1s? Eoint venture? co-or1ination an1 feasibility stu1y 21I) " .6 #E /#I18 #0FE&) #0 0S/3 )0 S)/#) 01 1E@ E1)E# #ISE - Pro@ect =or; M Feasibility re2ortC Planning? resource mobiliAation an1 im2lementation. #eference ) ). A;hauri? M.M.P.()HH*)< "ntre2reneurshi2 for 6omen in 7n1ia? $7"S(U&? $e= &elhi. 0 0. #isrich? '.& : (rush? C.%.()HH5) he 6omen "ntre2reneurs? &.C. #ealth : Co.? oranto. . .. #isrich? '.&. an1 Peters? M.P. ()HH4)< "ntre2reneurshi2 M Starting? &evelo2ing an1 Managing a $e= "nter2rise? 'ichar1 &.? 7n=in? 7$C? USA. , ,. Mere1ith? %.%. etal ()H90)< Practice of "ntre2reneurshi2? 7LO? %eneva. 4 :. Patel? >.C.()H9/)< 6omen "ntre2reneurshi2 M &evelo2ing $e= "ntre2reneurs? Ahme1aba1 "&77.