生物等效性试验中纳入不同性别受试者的科学考虑与建议  

Scientific consideration and suggestion of incorporating different gender subjects into bioequivalence trial

作　　者：陈露露 王欣桐 陈思雨 李晓晖 余鹏 欧阳冬生 CHEN Lu-lu;WANG Xin-tong;CHEN Si-yu;LI Xiao-hui;YU Peng;OUYANG Dong-sheng(Changsha Duxact Biotech Co,Ltd.,Changsha 410000,Hunan Province,China;Hunan Key Laboratory for Bioanalysis of Complex Matrix Samples,Changsha 410000,Hunan Province,China;Department of Clinical Pharmacology,Xiangya Hospital,Central South University,Changsha 410000,Hunan Province,China)

机构地区：[1]长沙都正生物科技有限责任公司,湖南长沙410000 [2]复杂基质样本生物分析湖南省重点实验室,湖南长沙410000 [3]中南大学湘雅医院临床药理研究所,湖南长沙410000

出　　处：《中国临床药理学杂志》2020年第18期2936-2942,共7页The Chinese Journal of Clinical Pharmacology

摘　　要：二十世纪九十年代以前开展的生物等效性(BE)试验一般纳入健康男性受试者,再将数据外推至所有人群。随着美国食品药品监督管理局(FDA)和欧洲药品管理局(EMA)等组织相继提出BE研究中应当同时纳入男性和女性受试者,标志着性别差异在仿制药开发中的重要性受到关注。关于BE研究中是否需要同时纳入男性和女性受试者在国际上尚无统一要求。本文作者从性别差异发生机制、评价方法、药政监管等因素考虑,综述了BE研究中纳入性别因素考察的现行观点,并提出了建议,以期为我国BE研究的开展和相关指南的修订提供参考。Before the 1990s,bioequivalence(BE)studies were generally conducted in healthy males and then extrapolated to all populations.The importance of gender differences in generic drug development has been concerned,following the documents promulgated by Food and Drug Administration(FDA),European Medicines Agency(EMA)et al.affirming the incorporating both males and females in BE trials.At present,there is no uniform regulation on whether males and females should be included in BE study.In this paper,the author reviewed the current views of incorporating gender factors into BE research from the mechanism,evaluation methods,drug administration supervision and other factors about gender difference,and put forward some suggestions,which in order to provide reference for the development of BE research in China and the revision of relevant guidelines.

关 键 词：生物等效性 生物利用度 性别差异 

分 类 号：R97[医药卫生—药品]