美國食品藥品管理局于2017年12月發(fā)布了《根據(jù)生物藥劑學(xué)分類系統(tǒng)豁免速釋固體口服制劑體內(nèi)生物利用度和生物等效性研究指導(dǎo)原則》的正式版本。該指導(dǎo)原則指出原料藥屬于生物藥劑學(xué)分類系統(tǒng)（BCS）1類（而且制劑是速溶的）和3類（而且制劑是極速溶的）的速釋（IR）固體口服制劑的生物利用度（BA）或生物等效性（BE）研究可獲得豁免。正式版本對2015年草案版做了許多修訂。詳細(xì)介紹該指導(dǎo)原則的正式版本并標(biāo)明約30處修訂。該指導(dǎo)原則對我國IR固體口服制劑BA或BE研究的豁免和監(jiān)管有重要參考價值。

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.