摘要
本文通过分析欧洲药品管理局(EMA)复方药物非临床评价指导原则的起草背景和具体内容,介绍了EMA对复方药物非临床安全性评价的考虑要点,包括复方药物的类型以及不同类型复方药物非临床评价方案,以期为国内复方药物的非临床研究提供参考。文中同时对复方药物非临床评价的毒理学研究内容以及应关注的剂量确定、动物种属选择和时间安排等原则要求作了分析。
The background and content of the guideline on nonclinical evaluation of fixed combinations of medicinal products issued by European Medicines Agency（EMA） were reviewed in this article. The key points of nonclinical safety evaluation of fixed combinations of medicinal products were introduced, as well as the evaluation protocols for different types of products, expecting to provide useful guidance for the nonclinical evaluation of fixed combinations in China. Meanwhile, the contents of toxicity studies, dose selection, species selection and the schedules of nonclinical studies were also introduced.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2012年第16期1846-1848,共3页
Chinese Journal of New Drugs
关键词
欧洲药品管理局
复方药物
非临床评价
指导原则
European Medicines Agency （EMA）
combination drugs
nonclinical evaluation
guideline
