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Risk Assessment in the 21st Century: Changes Wrought by Changing Science

机译：21世纪的风险评估：科学变革带来的变化

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Krewski et al. (2009) have provided an admirably concise overview of the NRC (2007) report, Toxic-ity Testing in the 21st Century: A Vision and a Strategy. The full report is rich with insights and ideas, and I would urge readers of Risk Analysis to study its fuller development of the questions addressed by Krewski et al. The NRC Committee envisions not simply the advent of new testing technologies (although these will come) but a consequent shift in the questions that toxicology is able to address and therefore will seek to elucidate. The focus will shift away from apical endpoints in whole animals (with subsequent work attempting to explain underlying causes and to assess their potential operation in humans at environmental exposure levels) and toward detecting perturbation of normal physiology itself as the primary object of testing (with subsequent inferences about the disease processes in humans that might be affected). That is, the flow of inference is being reversed-no longer from ultimate effects backward to potential underlying causes but now from causes forward to their ultimate potential effects. The NRC report argues that this would be more efficient and better able to address concerns such as human relevance, sensitive subpopulations, and interindividual variability. It would be a mistake to regard testing for physiological perturbation as only the development of better biomarkers or predictors of traditional apical endpoints—the perturbations themselves are the object of the envisioned new paradigm in testing.
机译：Krewski等。 （2009年）提供了NRC（2007年）报告《 21世纪的毒性测试：愿景和战略》的简明扼要的概述。这份完整的报告充满了见解和想法，我敦促风险分析的读者研究其对Krewski等人所提出问题的更全面发展。 NRC委员会不仅设想新测试技术的出现（尽管这些技术将会出现），而且还涉及毒理学能够解决并因此寻求阐明的问题的转移。重点将从整个动物的顶端端点转移（随后的工作试图解释潜在原因，并评估其在环境暴露水平下对人类的潜在作用），并将检测正常生理本身的扰动作为测试的主要对象（随后进行）关于可能受到影响的人类疾病过程的推论）。就是说，推论的流程正在被逆转，不再从最终结果向潜在的根本原因倒退，而是从原因向前发展到最终的潜在影响。 NRC报告认为，这将更有效，更有效地解决诸如与人类相关，敏感的亚人群和个体间变异性等问题。将生理扰动的测试仅看作是更好的生物标记或传统根尖的预测指标的发展，这将是一个错误-扰动本身是测试中设想的新范式的目标。

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    《Risk analysis》 |2009年第4期|488-489|共2页
  • 作者

    Lorenz R. Rhomberg;

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    Gradient Corporation, 20 University Road, Cambridge, MA 02138, USA;

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