美國(guó)食品藥品監(jiān)督管理局（FDA）于2022年10月發(fā)布了“皮膚局部用皮質(zhì)類固醇：體內(nèi)生物等效性的供企業(yè)用的指導(dǎo)原則草案”，這是繼1995年發(fā)布“皮膚局部用皮質(zhì)類固醇：體內(nèi)生物等效性的供企業(yè)用的指導(dǎo)原則”20多年之后新的修訂版。該指導(dǎo)原則介紹1種證明局部用皮質(zhì)類固醇生物等效性的體內(nèi)藥效學(xué)方法。在該指導(dǎo)原則中對(duì)這種方法的研究設(shè)計(jì)、方法鑒定、數(shù)據(jù)分析和數(shù)據(jù)報(bào)告提出了詳細(xì)而具體的建議，還討論了評(píng)估關(guān)鍵性研究參數(shù)的考慮因素和方法。而我國(guó)目前還沒(méi)有類似的專門針對(duì)皮膚局部用皮質(zhì)類固醇的體內(nèi)藥效學(xué)生物等效性研究的指導(dǎo)原則。詳細(xì)介紹FDA該指導(dǎo)原則，期待對(duì)中國(guó)皮膚局部用皮質(zhì)類固醇體內(nèi)藥效學(xué)生物等效性研究和監(jiān)管有所幫助。

The US Food and Drug Administration (FDA) issued the "Topical Dermatologic Corticosteroids: in vivo BioequivalenceDraft Guidance for Industry" in October 2022, which is the new revised version more than 20 years after the issue of "Guidance for Industry Topical Dermatologic Corticosteroids: in vivo Bioequivalence" in 1995. This guidance introduces an in vivo pharmacodynamic approach for demonstrating the bioequivalence of topical corticosteroids. In this guidance, detailed and specific recommendations are provided for the research design, method qualification, data analysis and data reporting of this approach, and considerations and approaches for estimating key study parameters are also discussed.However, there is no similar guidance for the study of in vivo pharmacodynamic bioequivalence of topical corticosteroids in China. This article introduces the FDA's guidance in detail, expecting to be helpful for the study and supervision of the pharmacodynamic bioequivalence of topical corticosteroids in China.

R951