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Advisory Document of the Working Group on GLP: The Application of the Principles of GLP to in vitro Studies

机译：GLP工作组的咨询文件：GLP原理在体外研究中的应用

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As efforts to decrease the use of animals in safety testing are intensifying, in vitro methods are gaining a more prominent role as alternatives or supplements to in vivo safety testing. Anticipated developments in the fields of toxicogenomics, toxicoproteomics, toxicometabonomics and in various high through-put screening techniques are expected to enhance the importance of in vitro methodologies for safety testing, beyond their traditional use as test systems in the area of genetic toxicity testing. The OECD Working Group on Good Laboratory Practice considered it therefore worthwhile to develop further guidance specifically of relevance to the application and interpretation of the OECD Principles of GLP to in vitro studies. The Working Group established a Task Force under the leadership of Switzerland, which met in Bern on 12 to 13 February 2004. The Task Force comprised members of the Working Group or experts in in vitro testing nominated by them representing Belgium, France, Germany, Japan, the Netherlands, Switzerland, the United States and the European Commission. The draft Advisory Document developed by the Task Force was examined by the Working Group at its 18th Meeting in May 2004, where it was amended and endorsed. The Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology at its 37th Joint Meeting in turn endorsed the document and recommended that it be declassified under the authority of the Secretary-General.
机译：随着在安全性测试中减少使用动物的努力日渐增多，体外方法作为体内安全性测试的替代品或补充品正发挥着越来越重要的作用。毒理基因组学，毒理基因组学，毒物代谢组学以及各种高通量筛选技术领域的预期发展有望增强安全性体外方法的重要性，超越了传统方法在遗传毒性测试领域中作为测试系统的用途。经合组织良好实验室规范工作组认为，因此有必要制定进一步的指南，特别是与在体外研究中应用和解释OECD GLP原则有关的指南。工作组在瑞士领导下成立了一个工作队，该工作队于2004年2月12日至13日在伯尔尼举行了会议。工作队由工作组成员或由比利时，法国，德国，日本代表的他们提名的体外测试专家组成，荷兰，瑞士，美国和欧盟委员会。工作组在2004年5月的第18次会议上审查了工作队制定的咨询文件草案，并在此对草案进行了修改和认可。化学品委员会和化学品，农药和生物技术工作组在其第三十七次联席会议上又批准了该文件，并建议在秘书长授权下将其解密。

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    《OECD Papers》 |2004年第11期|p.373.1-373.18|共18页
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