Expert scientific judgment and cancer risk assessment: a pilot study of pharmacokinetic data.
Expert scientific judgment and cancer risk assessment: a pilot study of pharmacokinetic data.
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专家科学判断和癌症风险评估：药代动力学数据的初步研究。
DOI：
10.1111/j.1539-6924.1988.tb01205.x
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发表时间：
1988
期刊：
影响因子：
--
通讯作者：
Graham,JD
中科院分区：
文献类型：
--
作者：
Hawkins,NC;Graham,JD
当高剂量肿瘤数据外推至低剂量时，通常假设递送至靶细胞的致癌物剂量与给予测试动物的剂量成正比，即使暴露水平低于实验范围。由于药代动力学数据的可用性在某些情况下质疑这一假设的有效性，因此风险评估人员必须决定是否维持标准假设。据报道，一项针对甲醛的初步研究旨在证明专家的科学判断如何帮助指导有争议的风险评估，其中药代动力学数据被认为是不确定的。通过正式程序选出了八位药代动力学数据专家，并使用结构化访谈方案对每位专家进行了亲自访谈。结果表明，在这种情况下，专家的科学意见是两极分化的，风险评估人员可以通过专家认为在生物学上合理的一系列风险特征来应对这种情况。如果以有效的方式执行几种具体的研究策略，那么在这种情况下，专家意见很可能会趋同。引出专家的科学判断是评估药代动力学数据质量、表达风险评估的不确定性以及制定可能达成科学共识的研究议程的一个有前景的工具。
When high‐dose tumor data are extrapolated to low doses, it is typically assumed that the dose of a carcinogen delivered to target cells is proportional to the dose administered to test animals, even at exposure levels below the experimental range. Since pharmacokinetic data are becoming available that in some cases question the validity of this assumption, risk assessors must decide whether to maintain the standard assumption. A pilot study of formaldehyde is reported that was undertaken to demonstrate how expert scientific judgment can help guide a controversial risk assessment where pharmacokinetic data are considered inconclusive. Eight experts on pharmacokinetic data were selected by a formal procedure, and each was interviewed personally using a structured interview protocol. The results suggest that expert scientific opinion is polarized in this case, a situation that risk assessors can respond to with a range of risk characterizations considered biologically plausible by the experts. Convergence of expert opinion is likely in this case if several specific research strategies are executed in a competent fashion. Elicitation of expert scientific judgment is a promising vehicle for evaluating the quality of pharmacokinetic data, expressing uncertainty in risk assessment, and fashioning a research agenda that offers possible forging of scientific consensus.