FDA对皮肤局部用皮质类固醇体内药效学生物等效性研究的要求

美国食品药品监督管理局（FDA）于2022年10月发布了“皮肤局部用皮质类固醇：体内生物等效性的供企业用的指导原则草案”,这是继1995年发布“皮肤局部用皮质类固醇：体内生物等效性的供企业用的指导原则”20多年之后新的修订版。该指导原则介绍1种证明局部用皮质类固醇生物等效性的体内药效学方法。在该指导原则中对这种方法的研究设计、方法鉴定、数据分析和数据报告提出了详细而具体的建议,还讨论了评估关键性研究参数的考虑因素和方法。而我国目前还没有类似的专门针对皮肤局部用皮质类固醇的体内药效学生物等效性研究的指导原则。详细介绍FDA该指导原则,期待对中国皮肤局部用皮质类固醇体内药效学生物等效性研究和监管有所帮助。

FDA's requirements for in vivo pharmacodynamic bioequivalence study of topical dermatologiccorticosteroids

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.