以药效学参数为终点指标的生物等效性评价方法  

Bioequivalence evaluation method using pharmacodynamic parameters as endpoints

作　　者：沈朝壮 孙华 李超 王晓虎 谢海棠 SHEN Chaozhuang;SUN Hua;LI Chao;WANG Xiaohu;XIE Haitang(Graduate School,Wannan Medical College,Wuhu 241002,China;Anhui Provincial Center for Drug Clinical Evaluation,Yijishan Hospital of Wannan Medical College,Wuhu 241001,China)

机构地区：[1]皖南医学院研究生院,安徽芜湖241002 [2]皖南医学院弋矶山医院安徽省药物临床评价中心,安徽芜湖241001

出　　处：《药物评价研究》2022年第4期796-803,共8页Drug Evaluation Research

基　　金：皖南医学院弋矶山医院科技创新团队“攀峰”培育计划项目(KPF2019016)。

摘　　要：生物等效性是仿制药一致性评价的重要阶段。以药效学参数为终点指标评价生物等效性方法逐渐引发关注。在药动学方法无法实施或药动学参数无法灵敏地体现两药差异的情况下,选择合理的药效学参数作为终点指标可有效地评价药品之间的差异。参考相关指南、法规及文献,系统地阐述药效学方法的适用条件,根据量效曲线选择终点指标,终点参数分析以及具体药物方法设计等,为相关研究提供参考和帮助。Bioequivalence(BE) is an important stage in the consistency evaluation of generic drugs. The method of evaluating bioequivalence by using pharmacodynamic parameters as the endpoint index has gradually attracted attention. When the pharmacokinetic method cannot be implemented or the pharmacokinetic parameters cannot reflect the difference between the two drugs sensitively, choosing reasonable pharmacodynamic parameters as the endpoint can effectively evaluate the difference between the drugs. With reference to relevant guidelines, regulations and literature, this article systematically expounds the applicable conditions of pharmacodynamic methods, selects endpoint indicators according to the dose-response curve, analyzes endpoint parameters, and designs specific drug methods, etc., to provide reference and help for related research.

关 键 词：生物等效性 药效学参数 终点指标 量效曲线 

分 类 号：R969.1[医药卫生—药理学]