摘要
保证药物临床试验过程与结果的科学性和可靠性一直是临床试验质量控制的重点和难点。本文主要从试验设计、组织、实施、监查以及总结等方面对目前我国药物临床试验存在的若干质量问题进行分析和探讨。
How to assure clinical trial's courses and results scientific and reliable is always very important and difficult in clinical trial quality control. This paper mainly analyzes and discusses some quality control problems at current China from some aspects, such as clinical trial design, organization, monitor, carry - out, conclusions and so on.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2013年第2期155-157,共3页
The Chinese Journal of Clinical Pharmacology
基金
十二五"重大新药创制"科技重大专项基金资助项目(2011ZX09302-007-05)