摘要
药物临床试验是新药研发过程中的一个重要环节,其操作的规范程度直接关系着药物研发的成败。本文通过对上海市药物临床试验机构分布及近年申报新药主要涉及专业领域的分析,探索加强药物临床试验监管的思路。
Clinical trial is an important link in the chain of new drug research and development （ R＆D）. The results of drug R＆D directly depend on the extent of standardization of clinical trial. This paper explored the measures for the supervision and control of drug clinical trials according to the distribution of drug clinical trial institutions and the professional field related to new drug registration in recent years.
出处
《中国新药与临床杂志》
CAS
CSCD
北大核心
2009年第6期469-471,共3页
Chinese Journal of New Drugs and Clinical Remedies
关键词
临床试验
立法
药物
法规
药品注册
现场核查
监督管理
clinical trials
legislation, drug
regulation
drug registration
on-site inspection
supervision
