DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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PART III: NON-CLINICAL DATADrug Registration Guidance Document (DRGD)- Applicable to disease risk reduction claims(For new active ingredient, new combination of active ingredients and new dose)Table 18:No. Field Disease Risk Reduction Claims1.2.3.4.Overview of non-clinical testing strategy- nomenclature- structure- general propertiesPharmacology- related information (including academicliterature) of pharmacology studies on thedeclared efficacyPharmacokinetics- related information (including academicliterature) of pharmacokinetics studies on thedeclared efficacyToxicology- related information (including academicliterature) of toxicology studies5. Integrated overview and conclusions √6. Other toxicity studies if available √7.References- List of references used√√√√√- All information must be provided in the following format/ table:StudyTitleTypeofStudyProduct(formulation)Study Summary- Study Design (e.g. casecontrol, randomisedplacebo controlled, invitro data, cohort study)- Dosage- Subject- Study Duration- Outcome parametersSummary findings(Includes scientific details such asstrength of evidence [e.g. p-values], conclusions, anyshortcomings, etc.For traditional evidence includeenough information todemonstrate relevance)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 230
PART IV: CLINICAL DOCUMENTSDrug Registration Guidance Document (DRGD)- Applicable to disease risk reduction claims (for new active ingredient, newcombination of active ingredients and new dose).Table 19:No. Field Disease Risk Reduction Claims1. Clinical overview √2. Production Development Rational √3.4.5.6.7.Overview of Bio-pharmaceutics- To include associated analytical methodsOverview of Clinical Pharmacology- Summary of clinical pharmacology studiesOverview of Efficiency- Summary of clinical efficacyOverview of Safety- Summary of clinical safetyReferences- List of all clinical studies- List of key literature references- Published clinical papers√√√√√National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 231
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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