College of Veterinary Medicine, North Carolina State University, Raleigh, North Carolina, USA.
Prog Mol Biol Transl Sci. 2012;112:259-83. doi: 10.1016/B978-0-12-415813-9.00009-X.
Human health risk assessments have evolved from the more qualitative approaches to more quantitative approaches in the past decade. This has been facilitated by the improvement in computer hardware and software capability and novel computational approaches being slowly recognized by regulatory agencies. These events have helped reduce the reliance on experimental animals as well as better utilization of published animal toxicology data in deriving quantitative toxicity indices that may be useful for risk management purposes. This chapter briefly describes some of the approaches as described in the guidance documents from several of the regulatory agencies as it pertains to hazard identification and dose-response assessment of a chemical. These approaches are contrasted with more novel computational approaches that provide a better grasp of the uncertainty often associated with chemical risk assessments.
在过去十年中,人类健康风险评估已经从更定性的方法发展到更定量的方法。这得益于计算机硬件和软件功能的提高,以及监管机构逐渐认可的新颖计算方法。这些事件有助于减少对实验动物的依赖,更好地利用已发表的动物毒理学数据,得出可能对风险管理有用的定量毒性指数。本章简要描述了几个监管机构的指导文件中描述的一些方法,这些方法涉及化学物质的危害识别和剂量-反应评估。这些方法与更新颖的计算方法形成对比,后者可以更好地掌握化学风险评估中经常存在的不确定性。