以药动学方法评价的抗精神分裂症药物人体生物等效性研究的一般考虑  

General considerations for bioequivalence studies with pharmacokinetic methods for anti-schizophrenic drugs

作　　者：李娜 韩鸿璨 王骏 LI Na;HAN Hongcan;WANG Jun(Center of 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：《中国临床药理学与治疗学》2021年第12期1419-1425,共7页Chinese Journal of Clinical Pharmacology and Therapeutics

摘　　要：基于抗精神分裂症药物的特点,结合国内外不同监管机构对抗精神分裂症仿制药的生物等效性研究技术指导原则要求,以部分药物为例,从试验设计的角度讨论其在开展生物等效性研究时的考虑要点,为相关产品的研发和评价提供一定参考。On account of the characteristics of anti-schizophrenic drugs, combined with the technical guidelines for bioequivalence studies of anti-schizophrenic generic drugs in different regulatory institutions at home and abroad, taking some drugs as examples, this paper discusses the key points to be considered in carrying out bioequivalence studies from the perspective of experimental design, so as to provide certain reference for the research and development and evaluation of related products.

关 键 词：精神分裂症 仿制药 生物等效性研究 氯氮平 富马酸喹硫平 

分 类 号：R969.1[医药卫生—药理学] R794.3[医药卫生—药学]