药物研究开发实验室管理亟待完善  

Management of Pharmaceutical Research and Development Laboratory Needs to Be Improved

作　　者：郭荣珍[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2008年第6期448-450,457,共4页Chinese Pharmaceutical Affairs

摘　　要：药物研究开发过程中,由于缺少对实验室管理规范的要求,有些研究资料的原始性、科学性难以保证,增加了药品注册审核的难度,也为上市后不良反应事件的追溯以及药品安全事件的原因分析带来困难。加强药物研究开发实验室管理规范化建设是必要的,也是可行的。Some pharmaceutical research and development laboratories can＇t prove the authenticity of the documents they supplied, because of no normalization requirement to follow. It＇s hard to verify the authenticity of the information during pre-market approval application or to analysis the quality problems post-market. It is essential and feasible to establish and maintain a quality system for pharmaceutical research and development laboratory.

关 键 词：药物研究 药物开发 实验室 管理规范 

分 类 号：R95[医药卫生—药学] R197.325