体外群体生物等效性的统计分析方法

Population bioequivalence statistical testing for the in vitro data

美国食品药品监督管理局指导原则表明原研药以及仿制药的生物等效性可用体内外数据或体内数据评价,而体外数据的评价方法依赖于体外群体生物等效性(PBE)方法。关于体外群体生物等效性的执行在美国食品药品监督管理部门出台的相关法案中已有明确要求,其运用越来越得到申办者的重视,但国内尚属起步阶段且未付诸实用。因此,本文通过介绍体外群体生物等效性的评价准则,判断界限,相关参数的讨论以及计算方法并列举实例说明,以期为国内群体生物等效性评价提供科学性参考。

For the bioequivalence test between a brand-name drug and its generic copy,it may be established by in vivo and in vitro studies as indicated in U.S.Food and Drug Administration.The statistical testing to qualify for the in vitro option is population bioequivalence (PBE) method and it has been already well documented in U.S.Food and Drug Administration for many years.The in vitro assessment serves as a significant role in bioequivalent establishment.However,we do not find any details published in China.Our study focused on in vitro bioequivalence testing and also introduced PBE criterion,hypotheses and the statistical tests for the PBE.