Meek M E Bette
McLaughlin Centre for Population Health Risk Assessment, Institute of Population Health, University of Ottawa, Ontario, Canada.
Environ Mol Mutagen. 2008 Mar;49(2):110-6. doi: 10.1002/em.20369.
This paper summarizes recent developments in the continuing evolution of Human Relevance Frameworks to systematically consider the weight of evidence of hypothesized modes of action in animals and their potential human relevance for both cancer and non-cancer effects. These frameworks have been developed in initiatives of the International Life Sciences Institute Risk Sciences Institute and the International Programme on Chemical Safety engaging large numbers of scientists internationally. They are analytical tools designed to organize information in hazard characterization as a basis to clarify the extent of the weight of evidence for mode of action in animals and human relevance and subsequent implications for dose-response. They are also extremely helpful in identifying critical data gaps. These frameworks which are illustrated by an increasing number of case studies, have been widely adopted into international and national guidance and assessments and continue to evolve, as experience increases in their application.
本文总结了人类相关性框架不断演变的最新进展,该框架旨在系统地考量动物体内假定作用模式的证据权重及其对癌症和非癌症效应的潜在人类相关性。这些框架是在国际生命科学研究所风险科学研究所和国际化学品安全方案的倡议下制定的,吸引了大量国际科学家参与。它们是分析工具,旨在整理危害特征描述中的信息,以此为基础阐明动物作用模式和人类相关性的证据权重程度以及对剂量反应的后续影响。它们在识别关键数据缺口方面也极为有用。这些框架有越来越多的案例研究加以说明,已被广泛纳入国际和国家指南及评估中,并随着应用经验的增加而不断演变。