浅谈非临床研究与ADR监测  

A Preliminary Discussion on Non-Clinical Study and ADR Monitoring

作　　者：项晓娟[1] 全红[1] 

机构地区：[1]黑龙江中医药大学,哈尔滨150040

出　　处：《中国药事》2004年第8期479-480,共2页Chinese Pharmaceutical Affairs

摘　　要：“安全性”是药品基本要求之一 ,对药品安全性的评价则应从药品上市前、后两个阶段进行。药品上市前的安全性评价即非临床研究各项毒性实验以及新药临床试验 (Ⅰ ,Ⅱ ,Ⅲ期 ) ,而上市后的安全性评价则属于ADR监测范畴。本文旨在通过对药品非临床研究与ADR监测区别与联系的分析 ,阐明二者之间的联系 ,使人们对药品安全性评价加以全面的认识。To be safety is the elementary requirement for drugs. The evaluation of drug safety should be made from both pre-marketing stage and post-marketing stage. The former stage includes non-clinical trial and clinical trial study while the latter is ADR monitoring stage. This paper analyzed and expressed the relationship and difference between non-clinical trial and ADR monitoring, lead a comprehensive understanding of drug safety evaluation.

关 键 词：非临床研究 安全性评价 ADR监测 区别 联系 

分 类 号：R954.7[医药卫生—药学] R994.11