中国临床药理学杂志2009，Vol.25Issue(6)：554-556,3.
心血管生物标记物与临床研究替代终点在药物注册方面的应用
Cardiovascular biomarkers and surrogate endpoints in drug clinical trials
高晨燕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
Recent years, the possibility of biomarkers as a surrogate end-point in clinical trials of the drug development is discussed in many different therapeutic areas. Since 2003 , an international panel at the " Cardiovascular Biomarkers and Surrogate Endpoints Symposia" held in Bet-heada, Md, to discuss the use of biomarkers in the development of improved cardiovascular diagnostics and therapeutics. One purpose of the meeting is hoped to create efficiencies toward improved patient healthcare, accelerate drug development. The information presented in this article summarizes the perspective of different country's regulatory agencies in the cardiovascular biomarker and surrogate endpoints, hoping to give some reference for the domestic drug R and D and evaluator.关键词
生物标记物Key words
cardiovascular/ biomarker/ surrogate end points分类
医药卫生引用本文复制引用
高晨燕..心血管生物标记物与临床研究替代终点在药物注册方面的应用[J].中国临床药理学杂志,2009,25(6):554-556,3.
