中国临床药理学杂志2012，Vol.28Issue(8)：637-640,4.
创新药药学研究的基本考虑和问题
Considerations on pharmaceutical research and development of innovative drugs
王亚敏1
作者信息
- 1. 国家食品药品监督管理局 药品审评中心,北京 100038
- 折叠
摘要
Abstract
The research and development ( R&D) of innovative drugs should follow its own rules. The evaluation of innovative drugs should apply different strategies for investigational new drug applications(INDs)for phase 1, 2 and 3 and new drug application ( NDA). Due to limited knowledge and experiences, there are some problems on R&D and evaluation of innovative drugs. This article is intended to introduce considerations and important issues on pharmaceutical research and development of innovative drugs, based on some experiences in innovative drugs evaluation and FDA and EMEAs guidelines on CMC information of INDs.关键词
创新药/药学研究/基本考虑Key words
innovative drugs/ pharmaceutical research and development/ consideration分类
医药卫生引用本文复制引用
王亚敏..创新药药学研究的基本考虑和问题[J].中国临床药理学杂志,2012,28(8):637-640,4.
