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新的前进道路:替代方法验证跨部门协调委员会(ICCVAM)和国家毒理学计划替代毒理学方法评估跨部门中心(NICEATM)。

A new path forward: the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM).

作者信息

Casey Warren, Jacobs Abigail, Maull Elizabeth, Matheson Joanna, Clarke Carol, Lowit Anna

机构信息

NIH/NIEHS/DNTP/NICEATM, Research Triangle Park, North Carolina, USA.

FDA/CDER, Silver Spring, Maryland, USA.

出版信息

J Am Assoc Lab Anim Sci. 2015 Mar;54(2):170-3.

PMID:25836963
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4382621/
Abstract

In 2000, the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) was congressionally established, with representatives from Federal regulatory and research agencies that require, use, generate, or disseminate toxicologic and safety testing information. For over 15 y, ICCVAM and the National Toxicology Program's Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) have worked together to promote the development, validation, and regulatory acceptance of test methods that replace, reduce, or refine the use of animals in regulatory testing. In 2013, both NICEATM and ICCVAM underwent major changes to their operating paradigms, to increase the speed and efficiency of regulatory approval and industry adoption of 3Rs testing methods within the United States and internationally. Accordingly, increased emphasis has been placed on international activities, primarily through interaction with the Organization for Economic Cooperation and Development and participation in the International Cooperation on Alternative Test Methods. In addition, ICCVAM has committed to increasing public awareness of and transparency about federal agencies' 3R activities and to fostering interactions with stakeholders. Finally, although it continues to support ICCVAM, NICEATM's work now includes validation support for Tox21, a collaboration aimed at identifying in vitro methods and computational approaches for testing chemicals to better understand and predict hazards to humans and the environment. The combination of more efficient operating paradigms, increased international collaboration, improved communication and interaction with stakeholders, and active participation in Tox21 likely will substantially increase the number of 3Rs methods developed and used in the United States and internationally.

摘要

2000年,国会设立了替代方法验证跨部门协调委员会(ICCVAM),其代表来自需要、使用、生成或传播毒理学和安全测试信息的联邦监管及研究机构。15年多来,ICCVAM与国家毒理学计划的替代毒理学方法跨部门评估中心(NICEATM)共同努力,推动开发、验证并使监管机构接受能够替代、减少或优化在监管测试中使用动物的测试方法。2013年,NICEATM和ICCVAM的运作模式都经历了重大变革,以提高美国国内和国际上监管机构批准以及行业采用3R测试方法的速度和效率。因此,重点更多地放在了国际活动上,主要是通过与经济合作与发展组织互动以及参与替代测试方法国际合作。此外,ICCVAM致力于提高公众对联邦机构3R活动的认识和透明度,并促进与利益相关者的互动。最后,尽管NICEATM继续支持ICCVAM,但其工作现在还包括为Tox21提供验证支持,Tox21是一项旨在确定测试化学品的体外方法和计算方法以更好地理解和预测对人类和环境危害的合作项目。更高效的运作模式、加强国际合作、改善与利益相关者的沟通和互动以及积极参与Tox21,这些因素的结合可能会大幅增加美国国内和国际上开发和使用的3R方法的数量。

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本文引用的文献

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