ICH/FDA/EMA/WHO复方药物非临床试验指导原则比较

Comparison of guidelines from ICH/FDA/EMA/WHO on non-clinical studies of fixed combinations of medical products

本文通过综述国外医药管理机构ICH/FDA/EMA/WHO对复方药物非临床试验指导原则的内容,比较了不同机构对复方药物非临床评价要求,包括复方药物的类型、不同类型复方药物非临床要求的一般原则、研究方案,以及动物种属、特殊毒理试验的要求、复方剂量配比原则等内容,以期为国内复方药物的非临床评价提供借鉴。

The guidelines on non-clinical development of fixed combinations of medical products from ICH/FDA/EMA/WH0 were reviewed in this paper. We introduced the general consideration on nonclinical evaluation on combinations of medical products, involving .the different types, based on which the different planning of nonclinical studies. Meanwhile, there are also some introductions on principles of species selection, ratio set, and considerations of some specific toxicity studies. We expect to provide a useful guidance for the local fixed combinations nonclinical evaluation.