美国食品药品管理局于2017年12月发布了《根据生物药剂学分类系统豁免速释固体口服制剂体内生物利用度和生物等效性研究指导原则》的正式版本。该指导原则指出原料药属于生物药剂学分类系统（BCS）1类（而且制剂是速溶的）和3类（而且制剂是极速溶的）的速释（IR）固体口服制剂的生物利用度（BA）或生物等效性（BE）研究可获得豁免。正式版本对2015年草案版做了许多修订。详细介绍该指导原则的正式版本并标明约30处修订。该指导原则对我国IR固体口服制剂BA或BE研究的豁免和监管有重要参考价值。

FDA was released Guidance for Industry Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Final version) in December 2017. The guidance states that BA/BE studies on IR solid oral dosage forms with BCS 1 class (the preparations are rapidly dissolving) and 3 class (the preparation is very rapidly dissolving) may be exempted. The final version made a lot of revision to the 2015 draft. This article details the final version of the guidance and indicates about 30 revisions. The guidance has important reference value for the exemption and regulation of IR solid oral Dosage Forms BA/BE studies in China.