基于基准剂量方法的动物替代策略及其应用  

Benchmark dose-based animal alternative strategy and its applications

作　　者：邵侃 SHAO Kan(Department of Environmental and Occupational Health,School of Public Health-Bloomington,Indiana University,Bloomington,IN 47405,USA)

机构地区：[1]Department of Environmental and Occupational Health,School of Public Health-Bloomington,Indiana University,Bloomington,IN 47405,USA

出　　处：《中国药理学与毒理学杂志》2024年第10期783-786,共4页Chinese Journal of Pharmacology and Toxicology

摘　　要：剂量-反应评估作为风险评估中的关键定量步骤,其作用是确定安全剂量水平。与传统最大无害剂量方法相比,基准剂量(BMD)法促进了3R原则(减少、替代和优化)在毒理试验中的使用。本文综述了BMD法特性,包括对研究设计的依赖性较小、在起始点中更好地量化不确定性及整合额外信息能力等;总结了BMD法基于剂量-反应评估和数据整合在减少动物使用方面的作用。As a critical quantitative step in risk assessment,dose-response assessment is intended to identify a safe dose level based on experimental dose-response data.Compared with the traditional approach(no observed adverse effect level,NOAEL),the benchmark dose(BMD)methodology not only has several important advantages,but also greatly facilitates the 3R principle,e.g.,reduction,replacement,and refinement.In this review,after a brief introduction to the NOAEL approach and BMD methodology,three important features of the BMD methodology that are closely related to its ability to facilitate animal use reduction are discussed,including less dependence on study design,better quantification of uncertainty in point of departure(POD),and capability to combine additional information.Then,quantitative approximations are performed to study the extent to which the BMD methodology can reduce the animal use through better utilization of dose-response data and data integration.As the BMD methodology is being increasingly accepted as the preferred dose-response modeling approach,it will have a long-term impact on chemical risk assessment and facilitate the 3R principle.

关 键 词：基准剂量方法 3R原则 剂量-反应建模 替代毒理学 

分 类 号：R99[医药卫生—毒理学]