中国临床药理学杂志Issue(21)：2170-2174,5.DOI:10.13699/j.cnki.1001-6821.2015.21.026
新药临床试验申请评价基本考虑
Main consiration of investigational new drug clinical evaluaion
钱思源 1王涛1
作者信息
- 1. 国家食品药品监督管理总局 药品审评中心，北京 100038
- 折叠
摘要
Abstract
Clinical trials are the core of new drug, because efficacy and safety of new drug depends on clinical trials finally.This paper include four contents: evaluation mode of investigational new drug ( IND ) , contents of IND, main points of IND and strategic decision.This paper discusses the current direction of thinking on China Food and Drug Administration Center for Drug Evaluation application for clinical trial.关键词
新药临床试验/临床评价/创新药物/临床决策Key words
investigational new drug/clinical evaluation/new drug/clinical dicision分类
医药卫生引用本文复制引用
钱思源,王涛..新药临床试验申请评价基本考虑[J].中国临床药理学杂志,2015,(21):2170-2174,5.
