局部皮肤用药的生物等效性研究进展

Progress in bioequivalence study of topical dermatological drug products

局部皮肤用药的生物等效研究方法具有多样性,根据药物自身特点,所用研究方法有所区别。本文重点阐述了局部皮肤用药的吸收特征,并综述了多种研究方法的原理及适用范围,包括体内药代动力学(PK)方法、药效学(PD)方法、临床终点方法、皮肤PK研究方法(DPK)、体外终点研究方法以及豁免情形。同时,本文也总结了近年来的创新性局部皮肤用药的临床研究方法,希望能对局部皮肤用药的生物等效性研究起到一定的借鉴作用。

Bioequivalence study （BE） methods are diverse and drug dependent, which need further exploration. The present article demon- strated the absorption characteristics of topical dermatological drug products and reviewed the mechanism and application of many BE study methods, including in vivo pharmacokinetic method （ PK ）, pharmacodynamic method （PD）, in vivo clinical endpoint method, dermatopharmacokinetic method （DPK）, in vitro clinical endpoint method, and biowaiver. At the same time, the present article also summarized innovative BE method for topical dermatological drug. It may be useful for the bioequivalence study design of topical dermatological drugs and products.