摘要
目的 研究FDA发布的窄治疗指数药物相关目录及生物等效性研究相关内容,特别是《特定药物的生物等效性指导原则》,为我国仿制药质量和疗效一致性评价工作提供借鉴和帮助。方法 从窄治疗指数药物目录及给药方式、试验设计、受试者选择、检测物质选择、豁免条件等多个方面对FDA公布的窄治疗指数药物进行详细分析。结果 FDA不断完善窄治疗指数药物目录,其公布的涉及窄治疗指数药物目录及《特定药物的生物等效性指导原则》对具体化学仿制药的生物等效性评价从多个方面进行较为详细的规范,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窄治疗指数药物目录及相关生物等效性指导原则的背景下,FDA发布的窄治疗指数药物目录及相关规范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 FDA issued lists and guidance on Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs.METHODS FDA issued lists and Bioequivalence Recommendations for Specific Products related with Narrow Therapeutic Index Drugs was investigated in multiple aspects, including detailed drugs lists, bioequivalence study designs, selection of bioequivalence subjects,analytes to measure,bioequivalence waiver, selection of reference products.RESULTS Keeping updated lists and Bioequivalence Recommendations for Specific Products relative with Narrow Therapeutic Index 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.CONCLUSION Narrow therapeutic index list and 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 have not released similar list and guidance on specific narrow therapeutic index.
关键词
窄治疗指数药物 /
口服固体制剂 /
生物等效性试验
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Key words
narrow therapeutic index drug /
oral solid product /
bioequivalence
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朱凤昌, 王爱国, 刘颖, 张华吉, 韩凤, 曹秀萍, 丁丽霞.
FDA窄治疗指数药物目录及生物等效性指导原则介绍与分析[J]. 中国药学杂志, 2018, 53(24): 2137-2142 https://doi.org/10.11669/cpj.2018.24.015
ZHU Feng-chang, WANG Ai-guo, LIU Ying, ZHANG Hua-ji, HAN Feng, CAO Xiu-ping, DING Li-xia.
Investigation of FDA Issued List and Guidance for Bioequivalence Recommendations for Specific Products Related with Narrow Therapeutic Index Drugs[J]. Chinese Pharmaceutical Journal, 2018, 53(24): 2137-2142 https://doi.org/10.11669/cpj.2018.24.015
中图分类号：
R951
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参考文献
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