对药物非临床实验管理规范(GLP)的历史回顾及其辩证思考  

The History Review and Dialectical Thinking of Good Laboratory Practice(GLP)

作　　者：叶瑶珍[1] 肖健[1] 张翼[1] 张振南[1] 李校堃[1] 

机构地区：[1]温州医学院药学院,浙江温州325035

出　　处：《中国现代医生》2011年第16期158-160,共3页China Modern Doctor

摘　　要：药品非临床实验管理规范(GLP)是国家为保证新药临床前研究安全性试验资料的优质、真实、完整和可靠,针对药物安全性评价研究机构制定的基本要求。本文回顾了GLP的出现及发展历程,客观辩证了在GLP发展过程中新药研发与安全评价的关系、GLP实施与新药开发的矛盾等,提出对于我国未来GLP发展的见解。Good Laboratory Practice （GLP） is the basic request to the drug salty evaluation research institute for guaranteeing high quality, reality, integrity and reliability of preelinical study of new drug. We reviewed the appearance and development course of GLP, and dialectically analyzed the relationship between R＆D and safety evaluation of new drug, and the contradiction between GLP implementation and new drug development. We also proposed our opinions on the development of future GLP.

关 键 词：GLP 新药 安全评价 辩证思维 

分 类 号：R95[医药卫生—药学]