SEURAT: Safety Evaluation Ultimately Replacing Animal Testing-Recommendations for future research in the field of predictive toxicology

SEURAT: Safety Evaluation Ultimately Replacing Animal Testing-Recommendations for future research in the field of predictive toxicology
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DOI:
10.1007/s00204-014-1421-5
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发表时间:
2015-01-01
影响因子:
6.1
通讯作者:
Whelan, Maurice
Whelan, Maurice
中科院分区:
医学2区
文献类型:
--
作者:
Daston, George;Knight, Derek J.;Whelan, Maurice

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开发非动物方法来评估化学品引起全身毒性的可能性是现代科学的重大挑战之一。欧洲研究方案SEURAT在这一领域十分活跃,将于2015年12月结束其第一阶段SEURAT-1。借鉴SEURAT-1获得的经验,并赞赏基础科学和监管科学的国际进步,我们在这里反思SEURAT应该如何发展,并建议进一步的研究和开发应该沿着沿着两个互补和相互关联的工作流。第一个工作流将侧重于为监管科学开发新的“范式”方法。这里的目标是识别与毒性相关的“关键生物靶点”,并测试它们是否适合用作预测毒性的锚点。第二个工作流将侧重于在当前监管“范式”内整合和应用新的危害(和风险)评估方法,旨在使监管机构接受无动物试验策略(即将科学成就转化为监管)。这两个工作流的组件进行了讨论,并可能提供一个结构,为未来的研究计划在预测毒理学领域。
The development of non-animal methodology to evaluate the potential for a chemical to cause systemic toxicity is one of the grand challenges of modern science. The European research programme SEURAT is active in this field and will conclude its first phase, SEURAT-1, in December 2015. Drawing on the experience gained in SEURAT-1 and appreciating international advancement in both basic and regulatory science, we reflect here on how SEURAT should evolve and propose that further research and development should be directed along two complementary and interconnecting work streams. The first work stream would focus on developing new 'paradigm' approaches for regulatory science. The goal here is the identification of 'critical biological targets' relevant for toxicity and to test their suitability to be used as anchors for predicting toxicity. The second work stream would focus on integration and application of new approach methods for hazard (and risk) assessment within the current regulatory 'paradigm', aiming for acceptance of animal-free testing strategies by regulatory authorities (i.e. translating scientific achievements into regulation). Components for both work streams are discussed and may provide a structure for a future research programme in the field of predictive toxicology.