窄治療指數(shù)（NTI）藥物的定義與特點決定此類藥物仿制藥的生物等效性研究需建立更加科學(xué)、規(guī)范的研究設(shè)計與評價標(biāo)準(zhǔn)。對NTI藥物的定義與特點進行了梳理，對不同監(jiān)管機構(gòu)公布的NTI藥物進行整理，列出此類藥物生物等效性研究具體要求；結(jié)合中國發(fā)布的《窄治療指數(shù)藥物生物等效性研究技術(shù)指導(dǎo)原則》相關(guān)內(nèi)容，對NTI藥物口服固體制劑生物等效性試驗的審評提出幾點考慮，以期為開展此類藥物的生物等效性研究提供科學(xué)依據(jù)與參考。

The definition and characteristics of narrow therapeutic index (NTI) drugs determine the bioequivalence research of such chemical generic drugs needs more scientific and standard research design and evaluation criteria. In this paper, the list of published NTI drug and requirements for bioequivalence research of international regulatory agencies and China were reviewed. Combined with published NTI drugs bioequivalence research technical guidance of China,considerations were put forward in combination with the BE review of NTI solid oral preparations, in order to provide scientific reference for the bioequivalence research of NTI drugs.

R951