贴剂与贴膏剂生物等效性研究方案设计及关键点  

Design and key points of bioequivalence of patches and cataplasms

作　　者：李艳 李晓洁[2] 王秀英 汤博凯 安雅翾 刘亚利[2] LI Yan;LI Xiao-jie;WANG Xiu-ying;TANG Bo-kai;AN Ya-xuan;LIU Ya-li(Beijing Kelin Zhenhe Co.,Ltd.,Beijing 100011;The First Affiliated Hospital of Medical College of Shantou University,Shantou Guangdong 515041)

机构地区：[1]北京科林臻和医药科技有限公司,北京100011 [2]汕头大学医学院第一附属医院,广东汕头515041

出　　处：《中南药学》2022年第11期2455-2462,共8页Central South Pharmacy

摘　　要：贴剂与贴膏剂,尤其是透皮贴剂已成为国内产品研发或引进的新热点,但国家药品监督管理局(NMPA)对贴剂与贴膏剂没有发布具体的生物等效性(BE)试验指导原则。美国食品药品监督管理局(FDA)发布了28个贴剂与贴膏剂的特定药物BE指南,通过分析相关指南,贴剂与贴膏剂均需开展黏附性研究、皮肤刺激性与致敏性研究,透皮贴剂与贴膏剂需开展以药代动力学为终点的BE研究,局部作用贴剂应开展以临床为终点的BE研究。本文根据FDA相关指南,对贴剂与贴膏剂仿制药BE研究的方案设计、试验实施的关键点进行分析总结,以期为部分贴剂与贴膏剂仿制药的临床研究的规范性、科学性提供参考。Patches and cataplasms,especially transdermal patches,have become new research and import hotspots in China,but NMPA has not provided specific guidelines on the bioequivalence of patches and cataphasms.We analyzed 28 FDA bioequivalence recommendations for specific products of patches and cataplasms in this article.Adhesion study,skin irritation and sensitization study were required in the bioequivalence studies of all patches and cataplasms.Pharmacokinetic study was an important part in the bioequivalence of transdermal patches and cataplasms.Topical patches should use equivalence studies with clinical endpoint.In this paper,we analyzed and summarized the key points of clinical trial protocol design and operation of patches and cataplasms according to FDA guidance and hope to provide reference for their standardization of domestic clinical research.

关 键 词：贴剂 贴膏剂 生物等效性研究 药代动力学 

分 类 号：R94[医药卫生—药剂学]