探讨药物GLP机构中IACUC的职能和伦理审查流程  

Discussion on the Function and Ethical Review Process of IACUC in Drug GLP Organization

作　　者：孙昌华 张艳美 李水仙 范治云 李志坤 祝清芬 SUN Changhua;ZHANG Yanmei;LI Shuixian;FAN Zhiyun;LI Zhikun;ZHU Qingfen(Shandong Institute for Food and Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Jinan 250101,China)

机构地区：[1]山东省食品药品检验研究院,国家药品监督管理局仿制药研究与评价重点实验室,济南250101

出　　处：《实验动物科学》2021年第5期63-66,共4页Laboratory Animal Science

摘　　要：在药物非临床研究(GLP)的认证体系和实验动物的许可管理中,实验动物福利伦理委员会(IACUC)作为单位内部的监督机构,在实验动物的使用与管理、动物福利的落实、人员职业健康与安全等方面肩负着重要使命,并发挥重要的作用。本文结合山东省食品药品检验研究院药物安全评价中心IACUC在机构中的运行情况,探讨其职能和审查流程,为实验动物机构IACUC开展相关工作提供参考。In the certification system of Good Laboratory Practice(GLP)and the licensing management of laboratory animals,the Institutional Animal Care and Use Committee(IACUC),as the internal supervision organization of the unit,plays an important role in the management of laboratory animals,the implementation of animal welfare and the occupational safety.In combination with the operation situation of IACUC in the center of drug safety evaluation of Shandong institute for food and drug control,our study aims to discuss the function and review process of IACUC,in order to provide information for relevant works.

关 键 词：GLP IACUC 伦理审查 

分 类 号：Q95-337[生物学—动物学]