Page | ot 13 eCTD br version 32 = ml-administrative-information-and-prescribing-information = eCID Module 1 Regional Index [new] = m2-common-technical-document-summaries = m2-2-introduetion = 2.2 CTD Introduction [new] = m2-3-quality-overall-summary = m2-3-introduetion = 2.3.L Introduction to the Quality Overall Summary [new] = m2-3-s-drug-substance [manufacturer: amri] [substance: tg-2349] = 2.3.S.1 General Information [TG-2349, AMRI] [new] = 2.3.8.2 Manufacture [TG-2349, AMRI [new] = 2.3.8.3 Characterization [TG-2349, AMRI] [new] = 2.3.8.4 Control of Drug Substance [TG-2349, AMRI] [new] . ‘5 Reference Standards or Materials [TG-2349, AMRI] [new] = 2.3.8.6 Container Closure System [TG-2349, AMRI] [new] = 2.3.S.7 Stability [TG-2349, AMRIT [new] = m2-3-p-drug-product [manufacturer: patheon] [product name: tg-2349] [dosage form: oral solution 25 mg/1 mL] = 2.3.P.1 Description and Composition of the Drug Product [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = 2.3.P.2 Pharmaceutical Development [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] » 2.3.P.3 Manufacture [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] » 2.3.P.4 Control of Excipients [TG-2349, Oral Solution 25 mg/1 mL. Patheon] [new] = 2.3.P.5 Control of Drug Product [TG-2349, Oral Solution 25mg / Im, Patheon] [new] = 2.3,P.6 Reference Standards or Materials ('TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] “2322 Contain Closure System [TG-2349, Oral Solution 25 mg/1 mL. n] [new] pss ability [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = m2-3-pedrug-product [manufacturer: patheon} [product name: tg-2349] [dosage form: oral solution 200 mg/4 mL} = 2.3.P.1 Description and Composition of the Drug Product [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = 2.3.P.2 Pharmaceutical Development [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = 2.3.7.3 Manufacture [TG-2349, Oral Solution 200 mg/4 mL, Patheon! [new] = 2.3,P.4 Control of Excipients [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = 2.3.2.5 Control of Drug Product [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = 2.3.P.6 Reference Standards or Materials [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = 2.3.P.7 Container Closure System [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] 1» 2.3.P.8 Stability [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = m2-3-p-drug-product [manufactuter: patheon} [product name tg-2349 i teeba] [dosage form: oral solution 1 mL] file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0... 2011/5/20Page 2 of 13 = 2.3.P.1 Description and Composition of the Drug Produet [TG-2349 Placebo, Oral Solution | mL., Patheon| [new] = 2.3,P.2 Pharmaceutical Development [TG-2349 Placebo, Oral Solution 1 mL. Patheon] [new] = 2.3.P.3 Manufacture [TG-2349 Placebo, Oral Solution 1 mL., Patheon| ( [new] . c [TG-2349 Placebo, Oral Solution 1 mL. Patheon] [new] 1 2.3.P.5 Control of Drug P' (1G-2349 Placebo, Oral Solution 1 mL. Patheon] [new] = 2.3.P.6 Reference Standards or Materials [TG-2349 Placebo, Oral Solution ‘mL, Patheon] [new] = 23.P.7 Container Closure System [TG-2349 Placebo, Oral Solution 1 mL. Patheon] [new] = 2.3.P.8 Stability [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] -drug-produet [manufacturer: patheon] [product name: tg-2349 placebo] [dosage form: oral solution 4 mL] = 2.3.P.1 Description and Composition of the Drug Produet [TG-2349 Placebo, Oral Solution 4 mL, Patheon] [new] = 2.3.P.2 Pharmaceutical Development [TG-2349 Placebo, Oral Solution 4 mL. Patheon] new] = 2.3.P.3 Manufacture [TG-2349 Placebo, Oral Solution 4 ml., Patheon| [new] = 2.3.P.4 Control of Excipients [TG-2349 Placebo, Oral Solution 4 mL, Patheon] [new] = 2.3.P.5 Control of Drug Product [TG-2349 Placebo, Oral Solution 4 mL. Patheon] [new] = 2.3.0.6 Reference Standards or Materials [TG-2349 Placebo, Oral Solution — 4 mL, Patheon] [new] = 2.3.P.7 Container Closure System [TG-2349 Placebo, Oral Solution 4 mL. Patheon} [new] = 2.3.P.8 Stability [TG-2349 Placebo, Oral Solution 4 mL, Patheon] [new] = m2-4-nonelinical-overview = 2.4 Nonclinical Overview [new] = m2-6-nonclinical-written-and-tabulated-summaries = m2. troduction = 2.6.1 Introduction [new] «= m2-6-2-pharmacology-writter = 2.6.2 Pharmacology Written Summary [new] ‘pharmacology-tabulated-summary = 2.6.3 Pharmacology Tabulated Summary [new] = m2-6-4-pharmacokinetics-written-summary = 2.6.4 Pharmacokinetics Written Summary [new] = m2-6-5-pharmacokinetics-tabulated-summary = 2.6.5 Pharmacokinetics Tabulated Summary [new] -toxicology-written-summary = 2.6.6 Toxicology Written Summary [new] = m2 = m2. = m2-6-7-toxicology-tabulated-summary = 2.6.7 Toxicology Tabulated Summary [new] = m3-quality ¢ = m3-2-body-ofdata = m3-2-s-drug-substance [manufacturer: amri] [substance: tg-2349] = m3-2-s-1-general-information = m3-2-s-1-I-nomenclature file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0..._ 2011/5/20Page 3 ot 13 = 3.2.S.1.1 Nomenclature [TG-2349, AMRI] [new] = m3-2-s-1-2-structure = 3.2.8.1.2 Structure [TG-2349, AMRI] [new] = m3-2-S-1-3-general-properties = 3.2.S.1.3 General Properties [TG-2349, AMRI] [new] = 3.2.8.2.1 Manufacturer(s) [TG-2349, AMRI] [new] = m3-2-5-2-2-description-of-manufacturing-process-and-process- controls = 3.2,S.2.2 Description of Manufacturing Process and Process Controls [TG-2349, AMRI] [new] = m3-2-s-2-3-control-of-materials = 3.2.8.2.3 Control of Materials [TG-2349, AMRI] [new] = m3-2-s-2-4-controls-of-critical-steps-and-intermediates = 3.28.24 Controls of Critical Steps and Intermediates [TG- 2349, AMRI] [new] = m3-2-s-2-6-manufacturing-process-development = 3.2.8.2.6 Manufacturing Process Development [TG-2349, ‘AMRI] [new] characterisation 3-1-elucidation-of-structure-and-other-characteristics # 3.2.8.3,1 Elucidation of Structure and other Characteristics [EG-2349, AMRI] [new] = m3-2-s-3-2-impurities = 3.2.8.3.2 Impurities [TG-2349, AMRI] [new] = m3-2-s-4-control-of-drug-substance = m3-2-s-4-1-specification = 3.2.8.4.1 Specification [TG-2349, AMRI] [new] m3-2-s-4-2-analytical-procedures = 3.2.8.4.2 Analytical Procedures [TG-2349, AMRI] [new] m3-2-s-4-3-validation-of-analytical-procedures = 3.2.8.4.3 Validation of Analytical Procedures (TG-2349, ‘AMRI] [new] 4-4-batch-analyses = 3.2.8.4.4 Batch Analyses [TG-2349, AMRI] [new] 4-5-justification-of-specification 2.8.4.5 Justification of Specification [TG-, [new] -5-reference-standards-or-materials 1 3.2.8.5 Reference Standards or Materials [TG-2349, AMRI] [new] = m3- mntainer-closure-system = 3.2.8.6 Container Closure System [TG-2349. AMRIT] [new] stability-summary-and-conclusions = 3.2.S.7.1 Stability Summary and Conclusions [TG-2349, AMRI] [new] = m3-2-s-7-3-stability-data = 3.2.S.7.3 Stability Data [TG-2349, AMRI] [new] = m3-2-p-drug-product [manufacturer: patheon] [product name: tg-2349] [dosage form: oral solution 25mg/ImL} = m3-2-p-1-description-and-composition-of-the-drug-product = 3.2.P.1 Description and Composition of the Drug Product [TG-23 Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-2-pharmaceutical-development = m3 = m3 49, AMR. file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0..._ 2011/5/20Page 4 of 13 = 3.2.P.2.1 Components of the Drug Product 25 mg/l mL, Patheon] [new] = 3.2.P.2.2 Drug Product [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = 3.2.P.2.3 Manufacturing Process Development [TG-2349, Oral Solution 25 mg/l mL, Patheon] [new] = 3.2.P.2.4 Container Closure System [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = 3.2.P.2.5 Microbiological Attributes [TG-2349, Oral Solution 25 mg/I mL, Patheon] {new] = 3.2.P.2.6 Compatibility [TG-2349, Oral Solution 25 mg/1 mL. Patheon] [new] = -m3-2-p-3-manufacture = m3-2-p-3-1-manufacturers = 3.2.P.3.1 Manufacturers [1G-2349, Oral Solution 25 mg/l mL, Patheon] [new] = m3-2-p-3-2-batch-formula = 3.2.P.3.2 Batch Formula [TG-2349, Oral Solution 25 mg/l mL, Patheon] [new] = m3-2-p-3-3-description-of-manufacturing-process-and-proc controls, «= 3.2.P.3.3 Description of Manufacturing Process and Process ‘ontrols [TG-2349. Oral Solution 25 mg/1 mL. Patheon} [new] = m3-2-p-3-4-controls-of-critical-steps-and-intermediates # 3.2.P.3.4 Controls of Critical Steps and Intermediates [TG- 349, Oral Solution 2349, Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-4-control-of-exeipients [excipient: compendial] = m3-2-p-4-1-specifications = 3.2.P.4.1 Specifications [TG-2349, Oral Solution 25 mg/] mL. Patheon] [new] = m3-2-p-4-2-analytical-procedures = 3.2.P.42 Analytical Procedures [TG-2349, Oral Solution 25 mg/I mL, Patheon] [new] = m3-2-p-4-3-validation-of-analytical-procedures = 3.2.P.4.3 Validation of Analytical Procedures [TG-2349, Oral Solution 25 mg/I mL, Patheon] [new] = m3-2-p-4-4-justification-of-specifications = 3.2.P.4.4 Justification of Specifications [TG-2349, Oral Solution 25 mg/I mL, Patheon] [new] = m3-2-p-4-5-excipients-of-human-or-animal-origin = 3.2.P.4.5 Excipients of Human or Animal Origin [TG-2349. Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-4-6-novel-excipients = 3.2.P.4.6 Novel Excipients [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-5-control-of-drug-produet = m3-2-p-5-1-specifications = 3.2.P.5.1 Specifications [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-5-2-analytical-procedures = 3.2.P.5.2 Analytical Procedures [TG-2349, Oral Solution 25 mg/I mL, Patheon] [new] = m3-2-p-5-3-validation-of-analytical-procedures = 3.2.P.5.3 Validation of Analytical Procedures [TG-2349, Oral Solution 25 mg/I mL, Patheon] [new] file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0... 2011/5/20Page 5 of 13 = m3-2-p-5-4-batch-analyses = 3.2.P.5.4 Batch Analyses [TG-2349, Oral Solution 25 mg/1 mL, Patheon} [new] = m3-2-p-5-5-characterisation-of-impurities = 3.2.P.5.5 Characterization of Impurities [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-5-6-justification-of-specifications = 3.2.P.5.6 Justification of Specifications [TG-2349, Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-6-reference-standards-or-materials = 3.2.P.6 Reference Standards or Materials [TG-2349, Oral Solution 25 mg/l mL, Patheon] [new] = m3-2-p-7-container-closure-system = 3.2.P.7 Container Closure System [TG-2349. Oral Solution 25 mg/1 mL, Patheon] [new] = m3-2-p-8-stability = m3-2-p-8-1-stability-summary-and-conclusion = 3.2.P.8.1 Stability Summary and Conclusion [TG-2349, Oral Solution 25 mg/1 mL, Patheon] {new] = m3-2-p-8-3-stability-data = 3.2.P.8.3 Stability Data [TG-2349, Oral Solution 25 mg/1 mL Patheon] [new] = m3-2-p-drug-product [manufacturer: patheon] [product name: tg-2349] [dosage form: oral solution 200 mg/4 mL] = m3-2-p-I-description-and-composition-of-the-drug-product # 3.2.P.1 Description and Composition of the Drug Product [1G-2349. Oral Solution 200 mg/4 mL, Patheon] [new] = m3-2-p-2-pharmaceutical-development = 3.2.P.2.1 Components of the Drug Product [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = 3.2.2.2 Drug Product [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = 3.2.P.2.3 Manufacturing Process Development [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = 3.2.P.24 Container Closure System [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = 3.2.P.2.5 Microbiological Attributes [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = 3.2.P.2.6 Compatibility [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = m3-2-p-3-manufacture = m3-2-p-3-1-manufacturers = 3.2.P.3.1 Manufacturers [TG-2349, Oral Solution 200 me/4 mL, Patheon] [new] = m3-2-p-3-2-batch-formula = 3.2.P.3.2 Batch Formula [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] 1m3-2-p-3-3-description-of-manufacturing-process-and-process- controls # 3.2.P.3.3 Description of Manufacturing Process and Process Controls [TG-2349, Oral Solution 200 mg/4 mL, Patheon! [new] = m3-2-p-3-4-controls-of-critical-steps-and-intermediates = 3.2,P.3.4 Controls of Critical Steps and Intermediates [TG- 2349, Oral Solution 200 mg/4 mL, Patheon] [new] file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0...__ 2011/35/20Page 6 of 13 = m3-2-p-4-control-of-excipients [excipient: compendial] = m3-2-p-4-1-specifications = 3.2.P.4.1 Specifications [TG-2349, Oral Solution 200 me/4 mL. Patheon] [new] = m3-2-p-4-2-analytical-procedures C = 3.2.P.4.2 Analytical Procedures [TG-2349, Oral Solution 200 mg/4 mL., Patheon] [new] = m3-2-p-4-3-validation-of-analytical-procedures 1 3.2.P.4.3 Validation of Analytical Procedures [TG-2349, Oral Solution 200 mg/4 mL., Patheon] [new] = m3-2-p-4-4-justification-of-specifications = 3.2.P.4.4 Justification of Specifications [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = m3-2-p-4-5-excipients-of-human-or-animal-origin = 3.2.P.4.5 Excipients of Human or Animal Origin [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] 1 m3-2-p-4-6-novel-excipients = 3.2.P.4.6 Novel Excipients [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = m3-2-p-5-control-of-drug-product «= m3-2-p-5-1-specifications = 3.2.P.5.1 Specifications [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = m3-2-p-5-2-analytical-procedures = 3.2.P.5.2 Analytical Procedures [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = m3-2-p-5-3-validation-of-analytical-procedures = 3.2.P.5.3 Validation of Analytical Procedures [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = m3-2-p-5-4-batch-analyses = 3.2.5.4 Batch Analyses [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = m3-2-p-5-5-characterisation-of-impurities = 3.2.P.5.5 Characterization of Impurities [TG-2349, Oral Solution 200 mg/4 ml. Patheon] [new] = m3-2-p-5-6-justification-of-specifications = 3.2.P.5.6 Justification of Specifications [TG-2349, Oral lution 200 mg/4 mL., Patheon] [new] = m3-2-p-6-reference-standards-or-materials = 3.2.P.6 Reference Standards or Materials [TG-2349, Oral Solution 200 mg/4 mL. Patheon] [new] = m3-2-p-7-container-closure-system = 3.2.P.7 Container Closure System [TG-2349, Oral Solution 200 mg/4 mL, Patheon] [new] = m3-2-p-8-stability «= m3-2-p-8-1-stability-summary-and-conclusion = 3.2.P.8.1 Stability Summary and Conclusion [TG-2349, Oral Solution 200 mg/4 ml., Patheon] [new] = m3-2-p-8-3-stability-data = 3.2.P.8.3 Stability Data [TG-2349, Oral Solution 200 mg/4 mL. Patheon} [new] c = m3-2-p-drug-product [manufacturer: patheon] [product name: tg-2349 placebo] [dosage form: oral solution 1 mL.] « m3-2-p-1 description-and-composition-of-the-drug-product = 3.2.P.1 Description and Composition of the Drug Product [TG-2349 file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0..._ 2011/5/20Page 7 of 13 Placebo, Oral Solution 1 mL, Patheon] [new] = m3-2-p-2-pharmaceutical-development = 3.2.2.1 Components of the Drug Product [TG-2349 Placebo, Oral Solution | mL, Patheon] [new] = 3.2.P.2.2 Drug Product [TG-2349 Placebo, Oral Solution | mL. Patheon] [new] = 3.2.P.2.3 Manufacturing Process Development [TG-2349 Placebo, Oral Solution 1 mL. Patheon] [new] = 3.2.P.2.4 Container Closure System [TG-2349 Placebo, Oral Solution mL, Patheon] [new] -2.P.2.5 Microbiological Attributes [TG-2349 Placebo, Oral Solution | mL. Patheon} [new] = 3.2.P.2.6 Compatibility [TG-2349 Placebo, Oral Solution 1 mL. Patheon] [new] manufacture p-3-1-manufacturers = 3.2.P.3.1 Manufacturers [TG-2349 Placebo, Oral Solution 1 mL. Patheon] [new] = m3-2-p-3-2-bateh-formula = 3.2.3.2 Batch Formula [TG-2349 Placebo, Oral Solution | mL, Patheon] [new] = m3-2-p-3-3-description-of-manufacturing-process-and-process- controls = 3.2.P.3.3 Description of Manufacturing Process and Process Controls [TG-2349 Placebo, Oral Solution | mL, Patheon] [new] = m3-2-p-3-4-controls-of-critical-steps-and-intermediates = 3.2.P.3.4 Controls of Critical Steps and Intermediates [TG- 2349 Placebo, Oral Solution 1 mL, Patheon] [new] -control-of-excipients (excipient: compendial] = -m3-2-p-4-1-specifications 3.2.P.4.1 Specifications [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] = m3-2-p-4-2-analytical-procedures = 3.2.P.4.2 Analytical Procedures [TG-2349 Placebo, Oral {olution 1 mL. Patheon] [new] = m3-2-p-4-3-validation-of-analytical-procedures = 3.2.P.4.3 Validation of Analytical Procedures [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] tification-of-specifications = 3.2.P.4.4 Justification of Specifications [TG-2349 Placebo. Oral Solution 1 mL, Patheon] [new] 5-excipients-of-human-or-animal-origin Placebo, Oral Solution | mL., Patheon] [new] m3-2-p-4-6-novel-excipients = 3.2.P.4,6 Novel Excipients [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] = m3-2-p-S-control-of-drug-product = m3-2-p-5-1-specifications = 3.2.P.5.1 Specifications [TG-2349 Placebo, Oral Solution 1 mL. Patheon] {new] = m3-2-p-5-2-analytical-procedures = 3.2.P.5.2 Analytical Procedures [TG-2349 Placebo, Oral Solution | mL. Patheon] [new] file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0...__ 2011/5/20Page 8 of 13, m3-2-p-5-3-validation-of-analytical-procedures = 3.2.P.5.3 Validation of Analytical Procedures [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] m3-2-p-5-4-batch-analyses = 3.2,P.5.4 Batch Analyses [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] m3-2-p-5-5-characterisation-of-impurities = 3.2.5.5 Characterization of Impurities [TG-2349 Placebo. Oral Solution 1 mL, Patheon] [new] m3-2-p-5-6-justification-of-specifications = 3.2.P.5.6 Justification of Specifications [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] = m3-2-p-6-reference-standards-or-materials 1 3.2.P.6 Reference Standards or Materials [TG-2349 Placebo, Oral Solution | mL, Patheon] [new] = m3-2-p-7-container-closure-system = 3.2.P.7 Container Closure System [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] = m3-2-p-8-stability = m3-2-p-8-1-stability-summary-and-conclusion = 3.2.P.8.1 Stability Summary and Conclusion [TG-2349 Placebo, Oral Solution 1 mL, Patheon] [new] = m3-2-p-8-3-stability-data P.8.3 Stability Data [TG-2349 Placebo, Oral Solution 1 mL. Patheon] [new] = m3-2-p-drug-produet [manufacturer: patheon] [product name: tg-2349 placebo] [dosage form: oral solution 4 mL] = m3-2-p-1-description-and-composition-of-the-drug-product = 3.2,P.1 Description and Composition of the Drug Product [TG-2349 Placebo, Oral Solution 4 mL, Patheon] [new] = m3-2-p-2-pharmaceutical-development = 3.2,P.2.1 Components of the Drug Product [TG-2349 Placebo, Oral, Solution 4 mL, Patheon] [new] 3.2.P.2.2 Drug Product [TG-2349 Placebo, Oral Solution 4 mL. Patheon] [new] = 3.2.P.2.3 Manufacturing Process Development [TG-2349 Placebo. Oral Solution 4 mL, Patheon] [new] = 3.2.P.2.4 Container Closure System [TG-2349 Placebo. Oral Solution 4mL, Patheon] [new] 1» 3.2.P.2.5 Microbiological Attributes [TG-2349 Placebo, Oral Solution 4 mL. Patheon] [new] = 3.2.P.2.6 Compatibility [TG-2349 Placebo, Oral Solution 4 mL. Patheon} [new] = m3-2-p-3-manufacture = m3-2-p-3-1-manufacturers = 3.2.P.3.1 Manufacturers [TG-2349 Placebo, Oral Solution 4 mL, Patheon] [new] = m3-2-p-3-2-batch-formula = 3.2.P.3.2 Batch Formula [TG-2349 Placebo, Oral Solution 4 mL, Patheon} [new] = m3-2-p-3-3-deseription-of- manufacturing-process-and-process- controls = 3.2.P.3.3 Description of Manufacturing Process and Process Controls [TG-2349 Placebo, Oral Solution 4 mL, Patheon [new] file://C:\Documents and Settings\jeffliu\My Documents\eIND-FDA-Final-Document\0..._ 2011/5/20Page 9 of 13 p-3-4-controls-of-critical = 3.2.3.4 Controls of Critical Steps and Intermediates [TG- 2349 Placebo, Oral Solution 4 mL, Patheon] [new] control-of-excipients [excipient: compendial] = m3-2-p-4-1-specifications = 3.2.P.4.1 Specifications [TG-2349 Placebo, Oral Solution 4 mL. Patheon] [new] = m3-2-p-4-2-analytical-procedures * 3.2.P.4.2 Analytical Procedures [TG-2349 Placebo, Oral Solution 4 mL. Patheon] [new] «= m3-2-p-4-3-validation-of-analytical-procedures = 3.2,P.43 Validation of Analytical Procedures [TG-2349 Placebo, Oral Solution 4 mL. Patheon} [new] = m3-2-p-4-4-justification-of-specifications = 3.2.P.4.4 Justification of Specifications [TG-2349 Placebo. .2.P.4.5 Excipients of Human or Animal Origin [TG-2349 Placebo, Oral Solution 4 mL., Patheon] new] = m3-2-p-4-6-novel-excipient = 3.2.P.4.6 Novel Exc (TG-2349 Placebo, O1 mL, Patheon] [new] = m3-2-p-S-control-of-

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