中国临床药理学与治疗学2017，Vol.22Issue(11)：1201-1206,6.
窄治疗指数药物的生物等效性评价进展
Advances in bioequivalence of narrow therapeutic index drugs
徐毛迪 1吴子静 1谢海棠2
作者信息
- 1. 皖南医学院,芜湖241002,安徽
- 2. 皖南医学院附属弋矾山医院临床药学部,芜湖241000,安徽
- 折叠
摘要
Abstract
In recent years,the evaluation of the bioequivalence (BE) of narrow therapeutic index (NTI) drugs has drawn much attention.Yet,there are still some controversial issues unresolved about how to evaluate the BE of NTI drugs.Currently in China,there is no relevant guideline for the BE studies of NTI drugs.This article introduces and analyzes the difficulties and major solutions to the BE study of NTI drugs.By referring to the domestic andforeign laws,guidelines and related literature,the BE evaluation of NTI drugs and reference-scaled average bioequivalence (RSABE) methods are introduced in hope of providing reference and help for the evaluation of generic drug quality and efficacy of narrow treatment index drugs in China.关键词
窄治疗指数药物/生物等效性/参比制剂校正的平均生物等效性(RSABE)Key words
narrow therapeutic index (NTI)drugs/bioequivalence/reference-scaled average bioequivalence (RSABE)分类
医药卫生引用本文复制引用
徐毛迪,吴子静,谢海棠..窄治疗指数药物的生物等效性评价进展[J].中国临床药理学与治疗学,2017,22(11):1201-1206,6.
