项宗尚,蔡永明,王海荣,张 骏,李春雨,张宗鹏.国际实验动物评估与认证的程序及意义[J].药物评价研究,2011,34(1):44-48
国际实验动物评估与认证的程序及意义
Research survey on fermentation of Chinese materia medica
投稿时间:2010-09-06  
DOI:10.7501/j.issn.0253-6376.[year].[issue].[sequence]
中文关键词:  国际试验动物评估与认证;实验动物管理与使用委员会(IACUC);兽医;职业安全与健康(OHS)
英文关键词:Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation; Institutional Animal Care and Use Committee (IACUC); veterinarian; occupational health and safety (OHS)
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
作者单位
项宗尚1,蔡永明1,王海荣1,张 骏2,李春雨1,张宗鹏1 1. 天津药物研究院 天津市新药安全评价研究中心,天津 300193 2. 天津医科大学 药学院,天津 300070 
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中文摘要:
      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。
英文摘要:
      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.
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