摘要
目的 研究分析FDA 陆续公布的《特定药物的生物等效性指导原则》,为我国正在进行的仿制药质量和疗效一致性评价工作提供借鉴和帮助。方法 针对生物等效性方面内容,结合我国国家食品药品管理总局颁布的最新指导原则(截止到2016年5月20日)以及FDA已颁布的相关生物等效性的指导原则,对FDA《特定药物的生物等效性指导原则》中涉及我国进行仿制药质量与疗效一致性评价的首批品种中的185个品种规格进行详细分析。结果 FDA陆续公布的《特定药物的生物等效性指导原则》对具体药物从剂型、给药方式、试验设计、受试者选择、给药条件、检测物质选择、豁免条件、体外溶出试验等多个方面,对化学仿制药的生物等效性评价进行较为详细的规范,是对相关生物等效性总则的补充和解读,对仿制药的发展有重要的推动作用。结论 在我国国家食品药品监督管理总局尚未颁布针对具体药物相关生物等效性指导原则的背景下, FDA公布的《特定药物的生物等效性指导原则》对我国正在进行的仿制药质量和疗效一致性评价具有一定指导和借鉴意义。
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.
关键词
仿制药研发 /
生物等效性试验 /
生物等效性试验豁免 /
检测物质
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朱凤昌, 王爱国, 郑稳生, 韩凤, 曹秀萍, 蒋奎, 孙文虹, 丁丽霞.
美国食品药品管理局(FDA)部分《特定药物的生物等效性指导原则》的介绍和分析[J]. 中国药学杂志, 2016, 51(18): 1615-1621 https://doi.org/10.11669/cpj.2016.18.016
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[J]. Chinese Pharmaceutical Journal, 2016, 51(18): 1615-1621 https://doi.org/10.11669/cpj.2016.18.016
中图分类号：
R969
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参考文献
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