常见窄治疗指数药物及其生物等效性评价现状

doi:10.12092/j.issn.1009-2501.2019.10.016

中国临床药理学与治疗学 ›› 2019, Vol. 24 ›› Issue (10): 1188-1193.doi: 10.12092/j.issn.1009-2501.2019.10.016

常见窄治疗指数药物及其生物等效性评价现状

陈小平，胡朝英，张兰

首都医科大学宣武医院药学部，I期临床研究中心，北京 100053

收稿日期:2019-01-25 修回日期:2019-09-12 出版日期:2019-10-26 发布日期:2019-10-28
通讯作者: 张兰，女，博士，教授，研究方向：临床药理学，神经药理学。 Tel：010-83198855 E-mail: lanizhg@126.com
作者简介:陈小平，男，硕士研究生，研究方向：临床药理学。 Tel：13261143703 E-mail：1029057881@qq.com
基金资助:
国家“重大新药创制”科技重大专项（2017ZX09101001-002-044）；北京市卫生系统高层次卫生技术人才（2014-2-014）；北京市博士后工作经费资助项目（2018-ZZ-105）

Common narrow therapeutic index drugs and the current status of bioequivalence evaluation

CHEN Xiaoping, HU Chaoying, ZHANG Lan

Pharmacy Department, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, Beijing 100053, China

Received:2019-01-25 Revised:2019-09-12 Online:2019-10-26 Published:2019-10-28

摘要/Abstract

摘要：

目前我国窄治疗指数药物的生物等效性评价仍存在一定盲区，尚未发布相关的指导原则。国际上主要药品监管机构对窄治疗指数药物的生物等效性研究要求各不相同，而且也没有全球统一的窄治疗指数药物目录，并且不同的地区对于相同的窄治疗指数药物其生物等效限要求也不同。本文参考国内外法规、指导原则及相关文献，分析和介绍了几种主要的窄治疗指数类药物及生物等效性研究的现状，希望能够对我国窄治疗指数药物生物等效性试验的开展和指导原则的制定有所帮助。

关键词: 窄治疗指数药物, 生物等效性试验, 等效限

Abstract:

There are still some blind areas in bioequivalence evaluation of narrow therapeutic index (NTI) drugs so far and no relevant guideline is issued in China. The bioequivalence requirements of NTI drugs are variable among the main international regulations, and there is no global unified NTI drugs list. In addition, for some particular NTI drugs, different equivalence limits are accepted in different regulatory regions. Based on domestic and foreign regulations, guidelines and related literature, through analyzing the status of several fundamental NTI drugs and the bioequivalence studies, we hope to contribute to the conduction of bioequivalence study in the future and to help the development of bioequivalence guideline of NTI drugs in China.

Key words: narrow therapeutic index drugs, bioequivalence, equivalence limit

中图分类号:

R541
R969

陈小平，胡朝英，张兰. 常见窄治疗指数药物及其生物等效性评价现状[J]. 中国临床药理学与治疗学, 2019, 24(10): 1188-1193.

CHEN Xiaoping, HU Chaoying, ZHANG Lan. Common narrow therapeutic index drugs and the current status of bioequivalence evaluation[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2019, 24(10): 1188-1193.

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常见窄治疗指数药物及其生物等效性评价现状

Common narrow therapeutic index drugs and the current status of bioequivalence evaluation

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