Guidelines for preparation of dossier

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Module 3: QualityInformation on Quality should be presented in the structured format as described below:3.1      Table of Contents of Module 33.2          Body of Data3.2. S              Drug substance(s)3.2. S.1            General Information3.2. S.2           Manufacture of Drug Substance (name, manufacturer)3.2. S.3            Characterization of Drug Substance (name, manufacturer)3.2. S.4            Quality Control of Drug Substance (name, manufacturer)3.2. S.5            Reference Standards or Materials (name, manufacturer)3.2. S.6            Container Closure System (name, manufacturer)3.2. S.7            Stability of Drug Substance (name, manufacturer)3.2. P               Drug product (name, dosage form)3.2. P.1            Description and Composition of the Drug Product (name, dosage form)3.2. P.2           Pharmaceutical Development (name, dosage form)3.2. P.3          Manufacture of drug product (name, dosage form)3.2. P.4          Controls of Excipients (name, dosage form)3.2. P.5          Control of Drug Product (name, dosage form)3.2. P.6          Reference Standards or Materials (name, dosage form)3.2. P.7          Container Closure System (name, dosage form)3.2. P.8          Stability (name, dosage form)3.2. A                Appendices3.2. A.1            Facilities and Equipment (name, manufacturer)3.2. A.2            Adventitious Agents for Safety Evaluation (name, dosage form, manufacturer)3.2. A.3            Excipients3.3       Literature ReferencesModule 4 : Nonclinical Study ReportsThe nonclinical study reports should be presented in the order described below:4.1       Table of contents of module 44.2       Study reports4.2.1                Pharmacology4.2.2               Pharmacokinetics4.2.3               Toxicology4.3       Literature referencesModule 5 : Clinical Study ReportsThe human study reports and related information should be presented in the order described below:5.1       Table of contents of module 55.2       Tabular listing of all clinical studies5.3       Clinical study report5.4       Literature References


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