Introduction and analysis of FDA issuedguidance on bioequivalence recommendations for specific products related with longhalf-life drugs / 中国药学杂志

OBJECTIVE: To study and analyze FDA issued guidance on Bioequivalence Recommendations for Specific Products related with long Half-life drugs. METHODS: Bioequivalence Recommendations for Specific Products related with long Half-life drugs was analyzed from multiple aspects, including bioequivalence study designs, selection of bioequivalence subjects, dosage, selection of reference products, analytes to measure, bioequivalence waiver on multiple-strength products and implementation of the Biopharmaceutics Classification System. RESULTS: Bioequivalence Recommendations for Specific Products issued by FDA are to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLSUTION: Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since there is not corresponding bioequivalence guidance on specific long Half-life drugs released by CFDA yet.

Introduction and analysis of guidance for industry bioequivalence recommendations for specific products issued by FDA / 中国药学杂志

OBJECTIVE: To investigate Guidance for Industry Bioequivalence Recommendations for specific products issued by FDA. METHOD: Combination with FDA and CFDA issued guidance related to Bioequivalence (up to May 20th, 2016), 185 FDA issued Guidance for Bioequivalence Recommendations for Specific Products were discussed, which are involved in the CFDA announced initial list of the equivalence assessment of quality and curative effect for generic products. RESULTS: Bioequivalence Recommendations for Specific Products issued by FDA is to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLUSION: Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since CFDA haven't released similar guidance on specific products yet.