Laboratory Animal Science ›› 2021, Vol. 38 ›› Issue (5): 63-.

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

  

  1. Shandong Institute for Food and Drug Control, NMPA Key Laboratory for Research and Evaluation of Generic Drugs, Jinan 250101, China
  • Online:2021-10-28 Published:2021-11-23

探讨药物 GLP 机构中 IACUC 的职能和伦理审查流程

  

  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

Abstract:

Abstract: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.

Key words: GLP, IACUC, ethical review

摘要：

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。

关键词: ">GLP, IACUC, 伦理审查

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