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局部用制剂生物等效性评估方法的进展

Progress in methodologies for evaluating bioequivalence of topical formulations.

作者信息

Shah V P

机构信息

Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, Maryland, USA.

出版信息

Am J Clin Dermatol. 2001;2(5):275-80. doi: 10.2165/00128071-200102050-00001.

Abstract

Assessment of bioequivalence of topical dermatological formulations is a challenge. Currently, comparative clinical studies are used to establish bioequivalence for most formulations (except corticosteroids). This article reviews different in vivo methodologies for determining bioequivalence, and the progress made in this area. Dermatopharmacokinetics is the term used to describe the pharmacokinetics of topically applied drugs in the stratum corneum. A tape stripping procedure used in dermatopharmacokinetic methodology measures the drug concentration in stratum corneum at the site of application. Various studies have shown dermatopharmacokinetics to be a reliable and reproducible method for determining bioequivalence, and have indicated that it is applicable for all topical dermatological drug products. However, confidence in this methodology needs to be established, particularly regarding its relevance to clinical drug efficacy.

摘要

评估局部皮肤用制剂的生物等效性是一项挑战。目前,比较临床研究被用于确立大多数制剂(皮质类固醇除外)的生物等效性。本文综述了用于确定生物等效性的不同体内方法,以及该领域所取得的进展。皮肤药代动力学是用于描述局部应用药物在角质层中的药代动力学的术语。皮肤药代动力学方法中使用的胶带剥离程序可测量应用部位角质层中的药物浓度。各种研究表明,皮肤药代动力学是一种用于确定生物等效性的可靠且可重复的方法,并表明它适用于所有局部皮肤用药品。然而,需要确立对该方法的信心,尤其是其与临床药物疗效的相关性。

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