窄治疗指数药物的生物等效性评价进展

摘要/Abstract

摘要：

近年来窄治疗指数类药物的生物等效性评价备受关注，关于窄治疗指数药物生物等效性如何评价，一些要点问题尚存很大的争议。目前国内尚无相关指导原则，本文分析和介绍了窄治疗指数类药物生物等效性研究的困难及主要解决方法，参考国内外法规、指导原则及相关文献，对窄治疗窗药物生物等效性评价及参比制剂校正的平均生物等效性（RSABE）方法展开介绍，以期对我国窄治疗指数类药物的仿制药质量与疗效一致性评价工作提供借鉴和帮助。

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）

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 and foreign 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.

Key words: narrow therapeutic index (NTI) drugs, bioequivalence, reference-scaled average bioequivalence (RSABE)

中图分类号:

R969.1

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.

XU Maodi，WU Zijing， XIE Haitang. Advances in bioequivalence of narrow therapeutic index drugs[J]. Chinese Journal of Clinical Pharmacology and Therapeutics.

参考文献

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