常见窄治疗指数药物及其生物等效性评价现状

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。

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

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.