Report of an ISRTP Workshop: Progress and barriers to incorporating alternative toxicological methods in the US
Report of an ISRTP Workshop: Progress and barriers to incorporating alternative toxicological methods in the US
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DOI：
10.1016/j.yrtph.2006.06.001
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发表时间：
2006-10-01
影响因子：
3.4
通讯作者：
Stott, William T.
中科院分区：
文献类型：
--
作者：
Becker, Richard A.;Borgert, Christopher J.;Stott, William T.
研讨会的目标是探索美国在监管评估框架和决策计划中实施新的、修订的和替代毒理学测试方法的进展，找出障碍并提出建议，以进一步促进采用减少、改进或取代动物方法使用的方法。研讨会包括以下会议：(1) 美国联邦政府内部替代方法的当前研究、开发和验证； (2) 新兴的替代方法，具有广泛的毒性评估策略的潜在应用； （3）分层评估（“智能测试”）策略； (4) 确定影响美国监管机构采用和使用新的、修订的替代毒理学测试方法的关键障碍，并提出解决这些障碍的建议。通过便利的讨论，制定了一系列障碍和建议，并将其分为经济/金融、科学/技术和监管/政策类别。总体而言，来自各个部门的参与者共同支持采取催化行动，以促进研究取得更有意义和快速的进展，以开发专注于监管计划的替代方法，加速实验室调查以验证此类替代方法，并采用包含和纳入这些经过验证的替代方法的监管框架。由爱思唯尔公司出版
The workshop objectives were to explore progress in implementing new, revised and alternative toxicological test methods across regulatory evaluation frameworks and decision-making programs in the United States, to identify barriers and to develop recommendations to further promote adoption of approaches that reduce, refine, or replace the use of animal methods. The workshop included sessions on: (1) current research, development, and validation of alternative methods within the U.S. federal government; (2) emerging alternative methodologies with potential applications to a broad spectrum of toxicity evaluation strategies; (3) tiered evaluation ("intelligent testing") strategies; and (4) identification of, and recommendations to address, critical barriers that affect adoption and use of new, revised alternative toxicological test methods by U.S. regulatory agencies. Through facilitated discussion, a list of barriers and recommendations were developed and grouped into categories of economic/financial, scientific/technical, and regulatory/policy. Overall, participants from all sectors collectively supported catalyzing actions to promote more meaningful and rapid progress for research to develop alternative methods focused for use in regulatory programs, accelerated lab investigations to validate such alternative methods and adoption of regulatory frameworks which embrace and incorporate these validated alternatives. Published by Elsevier Inc.