| 中药新药临床试验用药品的闭环管理模式研究 |
| |
| 引用本文： | 吴萍,张建武. 中药新药临床试验用药品的闭环管理模式研究[J]. 中国中药杂志, 2013, 38(17): 2898-2900 |
| |
| 作者姓名： | 吴萍 张建武 |
| |
| 作者单位： | 中国中医科学院 广安门医院, 北京 100053;北京市食品药品监督管理局, 北京 100053 |
| |
| 基金项目： | 国家"重大新药创制"科技重大专项(2013ZX09303301) |
| |
| 摘 要： | 该论文探讨了中药新药临床试验用药品管理的法规和技术要求,分析了管理中常见的问题,提出了建立中药新药临床试验用药品的闭环管理模式,并论述了闭环管理各环节的要求。
|
| 关 键 词： | 中药新药 临床试验用药品 闭环管理 模式 |
| 收稿时间： | 2013-08-07 |
Closed-loop management model of clinical investigational product for new drug of traditional Chinese medicine |
| |
| WU Ping and ZHANG Jian-wu. Closed-loop management model of clinical investigational product for new drug of traditional Chinese medicine[J]. China Journal of Chinese Materia Medica, 2013, 38(17): 2898-2900 |
| |
| Authors: | WU Ping and ZHANG Jian-wu |
| |
| Affiliation: | Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China;Beijing Food and Drug Administration, Beijing 100053, China |
| |
| Abstract: | This paper discussed the management regulations and technical requirements of clinical investigational product for new drug of traditional Chinese medicine, analyzed some common problems on the management of them, and proposed the establishment of closed-loop management model and management requirements in various aspects. |
| |
| Keywords: | new drug of traditional Chinese medicine clinical investigational product closed-loop management model |
|
