DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)Step II:f) Novel Excipients5. Control of Finished Productsa) Specificationsb) Analytical Proceduresc) Validation of Analytical Proceduresd) Batch Analysese) Characterization of impuritiesf) Justification of Specifications6. Reference Standards or Materials7. Container Closure System8. Stability9.No.Product Interchangeability/ Equivalent Evidence (Bioavailability/Bioequivalence, BA/BE)- Please refer 2.1.3 Additional information on requirements of BA andBE.Section S: Drug Substance1. General Informationa) Nomenclatureb) Structure and Attachment for Structure of Drug Substancec) General Properties2. Manufacturera) Manufacturer Name and Addressb) Description of Manufacturing Process and Process Controlsc) Controls of Materialsd) Controls of Critical Steps and Intermediatese) Process Validation and/or Evaluationf) Manufacturing Process DevelopmentNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 140
Drug Registration Guidance Document (DRGD)Step II:3. Characterisationa) Elucidation of Structure and Characteristicsb) Impurities4. Control of Drug Substancesa) Specificationsb) Analytical Proceduresc) Validation of Analytical Proceduresd) Batch Analysise) Justification of Specifications5. Reference Standards or Materials6. Container Closure System7. StabilityPART III: NONCLINICAL DOCUMENTSection A: Table of ContentsNo. Section B: Nonclinical Overview1. Overview of the Nonclinical Testing Strategy2. Pharmacology3. Pharmacokinetics4. Toxicology5. Integrated Overview & Conclusions6. List of Literature CitationsSection C: Nonclinical Written and Tabulated SummariesSection D: Nonclinical Study ReportsSection E: List of Key Literature ReferencesNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 141
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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