透皮贴剂生物等效性研究的评价方法与实施要点  

The evaluation method and implementation points of bioequivalence study of transdermal patches

作　　者：孙华[1] 梁大虎[1] 李相鸿[1] 胡骅[1] 徐毛迪 过怿赟[1] 谢海棠[1] SUN Hua;LIANG Da-hu;LI Xiang-hong;HU Hua;XU Mao-di;GUO Yi-yun;XIE Hai-tang(Center for Drug Clinical Evaluation,Yijishan Hospital Affiliated to Wannan Medical College,Wuhu 241000,China)

机构地区：[1]皖南医学院弋矶山医院药物评价中心,芜湖241000

出　　处：《中国新药杂志》2021年第24期2276-2282,共7页Chinese Journal of New Drugs

基　　金：科技创新团队-“攀峰”计划资助项目(KPF2019016)。

摘　　要：透皮贴剂因其独特的剂型优势已成为仿制药的研究热点。由于剂型的复杂性,透皮制剂的生物等效性研究往往面临更多的挑战,需从药动学、黏附力、刺激性与致敏性、贴剂残留等多方面考察与原研药的一致性,目前国内尚无指南参考。本文结合透皮贴剂国内外的研究现状,综合国外先进监管机构的指南及相关文献,对如何开展透皮贴剂的生物等效性研究进行系统阐述,为国内申请人从事相关研究提供参考。Transdermal products have become the research focus for generic pharmaceutical preparations due to their unique advantages relative to other dosage forms and routes of administration.As a result of the complexity of transdermal formulations the bioequivalence study often faces more challenges.Bioequivalence of transdermal patches requires demonstration of pharmacokinetic equivalence along with adhesion studies,skin irritation and sensitization studies and residual analysis of the patch after the intended duration of application,for which domestic authorities have not issued recommendations.This paper provides an overview of the patches approved in global market and systematically expounds general principles for the designing,conducting and evaluating of bioequivalence study of transdermal patches based on guidances addressed by regulatory authorities worldwide and related literatures,which would be referential for domestic sponsors to carry out bioequivalence research of transdermal patches.

关 键 词：透皮贴剂 生物等效性 仿制药 黏附力 刺激性与致敏性 体内体外相关性 

分 类 号：R972.6[医药卫生—药品]