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Needed: A Strategy for Implementing the Vision

机译:需要:实现愿景的战略

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摘要

The title of the NAS Report was Toxicity Testing in the 21st Century: A Vision and a Strategy. Both the NAS report itself, and the current synopsis, are long on the "vision thing" but short on the "strategy" part. What is needed next is more thought about how to turn this provocative vision into a reality for actually implementing the new paradigm for toxicity testing in regulatory risk assessments upon which important health and safety decisions are based.rnHow can the new paradigm actually become accepted in regulatory decision making? For example, are we ready to approve new drugs for market, or set regulatory limits for environmental agents, based solely on computational models of toxicity pathways? If the answer is "yes" in some cases, but "no" in others, how are we to distinguish the two? If the answer is "no, not yet," what's missing and how will we know when we are ready?
机译:NAS报告的标题是“ 21世纪的毒性测试:愿景和策略”。无论是NAS报告本身,还是当前的提要,在“视觉事物”上都很长,但在“战略”部分上很短。接下来需要更多地考虑如何将这种挑衅性的愿景变成现实,以便在重要的健康和安全决策所基于的监管风险评估中实际实施毒性测试的新范式。rn新范式实际上如何在监管中被接受做决定?例如,我们是否准备仅根据毒性途径的计算模型批准将新药推向市场,或为环境制剂设定监管限制?如果在某些情况下答案是“是”,而在其他情况下答案是“否”,那么我们如何区分两者呢?如果答案是“不,还没有”,那么遗漏了什么?准备就绪后如何知道?

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  • 来源
    《Risk analysis》 |2009年第4期|482-482|共1页
  • 作者

    E. Donald Elliott;

  • 作者单位

    Yale Law School, New Haven, CT, USA;

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  • 正文语种 eng
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