口服固体仿制药品生物等效性研究国际指导原则要点调研

发布时间：2018-11-09 14:14

【摘要】：目的研究FDA(美国食品药品管理局)、EMA(欧洲药品局)、WHO(世界卫生组织)、日本、澳大利亚等国家或组织颁布的生物等效性研究相关国际标准,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。方法从生物等效性试验设计、受试者选择、体内给药剂量、参比制剂选择、药动学参数、生物学统计方法、生物等效性试验豁免等方面对FDA(美国食品药品管理局)、EMA(欧洲药品局)、WHO(世界卫生组织)、日本、澳大利亚等国家或组织颁布的生物等效性研究相关国际标准进行对比分析。结果各国或国际组织发布的生物等效性研究指导原则虽大体一致,但为符合各自国情,仍保留诸多不同之处。结论通过研究不同国家或组织颁布的生物等效性研究指导原则,对比异同点,帮助我国广大医药学工作者更好理解生物等效性研究国际规则,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 study the relevant international standards for bioequivalence research issued by FDA (), EMA (European Drug Administration), WHO (World Health Organization) Japan Australia and other countries or organizations. To provide reference and help for the evaluation of quality and efficacy consistency of generic drugs in China. Methods from the aspects of bioequivalence test design, subject selection, drug dosage in vivo, reference preparation selection, pharmacokinetic parameters, biological statistical method, bioequivalence test exemption and so on, the FDA (Food and Drug Administration of the United States) was studied. EMA (European Drug Administration), WHO (World Health Organization), Japan, Australia and other countries or organizations issued by the international standards on bioequivalence were compared and analyzed. Results although the guidelines of bioequivalence research published by countries or international organizations are generally consistent, they still retain many differences in accordance with their respective national conditions. Conclusion by studying the guiding principles of bioequivalence research issued by different countries or organizations and comparing the similarities and differences, the majority of medical practitioners in China can better understand the international rules of bioequivalence research. The evaluation of quality and curative effect consistency of generic drugs in China is instructive and referential.
【作者单位】：中国药学会;
【分类号】：R95

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