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

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.