Hoffmann S, Hartung T
European Commission, Joint Research Centre, Institute for Health & Consumer Protection, European Centre for the Validation of Alternative Methods, 21020 Ispra VA, Italy.
Hum Exp Toxicol. 2006 Sep;25(9):497-513. doi: 10.1191/0960327106het648oa.
The increasing demands on toxicology of large-scale risk assessment programmes for chemicals and emerging or expanding areas of chemical use suggest it is timely to review the toxicological toolbox. Like in clinical medicine, where an evidence-based medicine (EBM) is critically reviewing traditional approaches, toxicology has the opportunity to reshape and enlarge its methodology and approaches on the basis of compounded scientific knowledge. Such revision would have to be based on structured reviews of current practice, ie, assessment of test performance characteristics, mechanistic understanding, extended quality assurance, formal validation and the use of integrated testing strategies. This form of revision could optimize the balance between safety, costs and animal welfare, explicitly stating and, where possible, quantifying uncertainties. After a self-critical reassessment of current practices and evaluation of the thus generated information, such an evidence-based toxicology (EBT) promises to make better use of resources and to increase the quality of results, facilitating their interpretation. It shall open up hazard and also risk assessments to new technologies, flexibly accommodating current and future mechanistic understanding. An EBT will be better prepared to answer the continuously growing safety demands of modern societies.
对化学品大规模风险评估计划以及化学品新兴或不断扩展的使用领域的毒理学要求日益增加,这表明现在是时候对毒理学工具箱进行审查了。就像临床医学中循证医学正在严格审视传统方法一样,毒理学有机会在综合科学知识的基础上重塑并扩大其方法和途径。这种修订必须基于对当前实践的结构化审查,即评估测试性能特征、机理理解、扩展质量保证、正式验证以及综合测试策略的使用。这种修订形式可以优化安全性、成本和动物福利之间的平衡,明确说明并在可能的情况下量化不确定性。在对当前实践进行自我批评式重新评估并对由此产生的信息进行评估之后,这种循证毒理学(EBT)有望更好地利用资源并提高结果质量,便于对结果进行解读。它将为新技术开辟危害评估和风险评估之路,灵活地适应当前和未来的机理理解。循证毒理学将更有准备地应对现代社会不断增长的安全需求。