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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。
The bioequivalence research methods of topical dermatological drugs are diversified. According to their own characteristics, the research methods used are different. This article focuses on the absorption characteristics of topical dermatological medications and summarizes the principles and applicability of various investigational methods including in vivo pharmacokinetic (PK) methods, pharmacodynamic (PD) methods, clinical endpoint methods, skin PK studies Methods (DPK), in vitro endpoint studies, and exemptions. In the meantime, this article also summarizes the clinical research methods of innovative topical dermal drug in recent years, hoping to be able to learn the bioequivalence study of topical dermal drug.