FDA基于生物药剂学分类系统的生物豁免最新进展

FDA's latest progress in biopharmaceutics classification system-based biowaiver

美国食品药品管理局(FDA)于2000年发布《基于生物药剂学分类系统豁免口服固体常释制剂人体生物利用度和生物等效性研究》指导原则,允许口服固体常释制剂在某些条件下基于生物药剂学分类系统(BCS)豁免人体生物利用度和/或生物等效性研究,即基于BCS的生物豁免。2017年12月,FDA正式更新该指导原则,对部分重要内容进行了修订。本文介绍FDA基于BCS的生物豁免发展过程、最新要求及应用情况,期望对我国相关研究和监管工作有所帮助。

The United States Food and Drug Administration（ FDA） issued a guidance for industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System in 2000,which made the recommendation that for immediate-released solid oral drug products,the in vivo bioavailability and/or bioequivalence studies can be waived under certain circumstances based on a Biopharmaceutics Classification System（ BCS）,also known as BCS-based biowaiver. In December 2017,FDA has issued a finalized update of this guidance,which includes revisions to several key aspects. This article describes FDA＇s development of current requirements and application of BCS-based biowaiver. The authors hope that this article will promote related researches and regulations in China.