国内外盐酸多柔比星脂质体注射液人体生物等效性研究现状及相关考虑  

Current status of doxorubicin hydrochloride liposome injection in domestic and foreign

作　　者：刘美霞 贺锐锐 LIU Mei-xia;HE Rui-rui(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2022年第16期1972-1976,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：盐酸多柔比星脂质体注射液为广谱抗肿瘤药,是国内外企业仿制开发的热点品种之一。本文通过对比分析国家药品监督管理局(NMPA)、美国药品监督管理局(FDA)、欧洲药品管理局(EMA)的生物等效性研究技术指导原则要求,总结国内外已上市品种的生物等效性研究情况,对本品国内外生物等效性研究中存在的难点进行了分析。以期为盐酸多柔比星脂质体注射液仿制药的研发提供一定参考。Doxorubicin hydrochloride liposome injection is a broad-spectrum antitumor drug,and it is also one of the key drugs which domestic and foreign enterprises set up project.In this study,by comparing and analyzing the technical guidelines for bioequivalence research of National Medical Product Administration(NMPA),Food and Drug Administration(FDA),and European Medicines Agency(EMA),and summarizing the bioequivalence research situation of domestic and foreign marketed drugs,the difficulties existing in the bioequivalence research of this product at home and abroad were analyzed.In order to provide a certain reference for the bioequivalence research of the generic drug of doxorubicin hydrochloride liposome injection.

关 键 词：盐酸多柔比星脂质体注射液 仿制药 生物等效性试验 

分 类 号：R95[医药卫生—药学]