[关键词]
[摘要]
国际实验动物评估与认证是实验动物管理和科学应用高标准的象征,是国际认可的质量标准。介绍国际实验动物评估与认证的基本概念、方法、步骤及注意事项等,特别是实验动物管理与使用委员会(IACUC)、兽医和职业安全与健康(OHS)在认证中的重要作用,阐述开展国际实验动物评估与认证对新药研发公司及研究机构在提高药品非临床安全性研究的质量与国际认可度,确保实验方案合理以及实验结果的可靠有效等方面的意义,为国内相关机构开展国际实验动物评估与认证起到抛砖引玉的作用。
[Key word]
[Abstract]
Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation is the symbol of high standards for animal care and use, and is the landmark of a world-wide acceptable high quality of medicinal research. In this paper, the basic concept and procedure of AAALAC accreditation as well as some special issues are introduced, the important role of Institutional Animal Care and Use Committee (IACUC), veterinarian, and occupational health and safety (OHS) to play in AAALAC accreditation is clarified, the significance of AAALAC accreditation in improvement of pre-clinical safety evaluation of an investigational drug is described with ensuring the reliability, validity, repeatability, and international recognition of the experiments and their results. It is very imperative for GLP laboratories in domestic institutions to get AAALAC accreditation.
[中图分类号]
[基金项目]
基金项目:“重大新药创制”科技重大专项(Z20082X09305-005);天津创新药物安全评价技术平台建设