Introduction and Analysis of Guidance for Industry Bioequivalence Recommendations for Specific Products Issued by FDA
ZHU Feng-chang1, WANG Ai-guo1, ZHENG Wen-sheng2, HAN Feng1, CAO Xiu-ping1, JIANG Kui1, SUN Wen-hong1, DING Li-xia1*
1. Chinese Pharmaceutical Association,Beijing 100022; 2.Institute of Materia Medica, Chinese Academy of Medical Sciences & Peking Union Medical college, Beijing 100050
Abstract��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.
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ZHU Feng-chang, WANG Ai-guo, ZHENG Wen-sheng, HAN Feng, CAO Xiu-ping, JIANG Kui, SUN Wen-hong, DING Li-xia. Introduction and Analysis of Guidance for Industry Bioequivalence Recommendations for Specific Products Issued by FDA. Chinese Pharmaceutical Journal, 2016, 51(18): 1615-1621.
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2016, Vol. 51 
