摘要
药品研发过程的规范性、科学性、严谨性．以及研发机构自身的价值理念决定着药品的研发质量与水平。目前我国对药品研发的监管还多停留在事后监管及现场检查等阶段．笔者通过对lCH^DSUR（研发阶段安全性更新报告）制度的介绍，和对其制定过程中理念的分析．以期在药品研发的过程控制方面给予我国借鉴与启示。
The level of standardization of drug research and development and the scientific capacity of research institutions determine the quality of pharmaceutical research and development process. In the present situation, supervision of drug research and development in China mainly includes site inspection and post-event supervision. The introduction of ICH DSUR （Development Safety Update Report） system, and the purpose and consideration in the formulation process may shed light on the quality control process in drug research and development in China.
出处
《药品评价》
CAS
2011年第16期32-35,共4页
Drug Evaluation
关键词
药物研发
临床试验
过程控制
DSUR
Drug research and development
Clinical research
Process control
DSUR
