| 简介欧盟医药管理局的肺动脉高压医药产品临床研究指导原则 |
| |
| 引用本文： | 华丛笑,康彩练.简介欧盟医药管理局的肺动脉高压医药产品临床研究指导原则[J].中国临床药理学杂志,2009,25(4). |
| |
| 作者姓名： | 华丛笑 康彩练 |
| |
| 作者单位： | 国冢食晶药品监骨霄理局药品审评中心,北京,100038 |
| |
| 摘 要： | 欧盟医药管理局的人用医药产品委员会(CHMP)于2008年12月18日,在伦敦发布了作为征求意见草案的CHMP关于治疗肺动脉高压医药产品的临床研究指导原则,旨在为评价新的用于联合治疗肺动脉高压的医疗产品或药物提供指南.本文旨在介绍该指南,为相关药物的临床试验设计和评价提供参考.
|
| 关 键 词： | 欧盟医药管理局 肺动脉高压药物 |
Introduction the European Medicine Agency guideline on the clinical investigations of medical products for the treatment of pulmonary arterial hypertension |
| |
| HUA Cong-xiao,KANG Cai-lian.Introduction the European Medicine Agency guideline on the clinical investigations of medical products for the treatment of pulmonary arterial hypertension[J].The Chinese Journal of Clinical Pharmacology,2009,25(4). |
| |
| Authors: | HUA Cong-xiao KANG Cai-lian |
| |
| Institution: | Center for Drug Evaluation;State Food and Drug Administration;Beijing 100038;China |
| |
| Abstract: | This article is to introduce the CHMP guideline on the clinical investigations of medical products for the treatment of pulmonary arterial hypertension newly released by European Medicines Agency,hoping to give some reference to design and evaluation of clinical trials for pulmonary arterial hypertension agents in China. |
| |
| Keywords: | European Medicines Agency pulmonary arterial hyperten-sion agents |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
