Introduction to benchmark dose methods and US EPA's benchmark dose software (BMDS) version 2.1.1
Introduction to benchmark dose methods and US EPA's benchmark dose software (BMDS) version 2.1.1
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DOI：
10.1016/j.taap.2010.10.016
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发表时间：
2011-07-15
影响因子：
3.8
通讯作者：
Zhao, Q. Jay
中科院分区：
文献类型：
--
作者：
Davis, J. Allen;Gift, Jeffrey S.;Zhao, Q. Jay
传统上，未观察到不良影响水平 (NOAEL) 方法已用于确定动物毒理学数据的出发点 (POD)，以用于人类健康风险评估。然而，这种方法受到明确定义的实质性限制，例如严格依赖于已确定关键效果的研究的剂量选择、剂量间隔和样本量。此外，NOAEL 方法未能考虑剂量反应曲线的形状和其他相关信息。基准剂量 (BMD) 方法最初是在 20 世纪 80 年代提出作为 NOAEL 方法的替代方法，解决了 NOAEL 方法的许多局限性。它较少依赖于剂量选择和间隔，并且考虑了剂量反应曲线的形状。此外，对 BMD 95% 置信下限 (BMDL) 的估计会产生适当考虑研究质量（即样本量）的 POD。随着最近出现的用户友好型 BMD 软件程序，包括美国环境保护署 (U.S. EPA) 基准剂量软件 (BMDS)，BMD 已成为全球许多卫生组织的首选方法。本文讨论了美国 EPA 开发的 BMD 方法和相应软件（即 BMDS 2.1.1 版），并与最近发布的欧洲食品安全局 (EFSA) BMD 指南进行了比较。由爱思唯尔公司出版
Traditionally, the No-Observed-Adverse-Effect-Level (NOAEL) approach has been used to determine the point of departure (POD) from animal toxicology data for use in human health risk assessments. However, this approach is subject to substantial limitations that have been well defined, such as strict dependence on the dose selection, dose spacing, and sample size of the study from which the critical effect has been identified. Also, the NOAEL approach fails to take into consideration the shape of the dose-response curve and other related information. The benchmark dose (BMD) method, originally proposed as an alternative to the NOAEL methodology in the 1980s, addresses many of the limitations of the NOAEL method. It is less dependent on dose selection and spacing, and it takes into account the shape of the dose-response curve. In addition, the estimation of a BMD 95% lower bound confidence limit (BMDL) results in a POD that appropriately accounts for study quality (i.e., sample size). With the recent advent of user-friendly BMD software programs, including the U.S. Environmental Protection Agency's (U.S. EPA) Benchmark Dose Software (BMDS), BMD has become the method of choice for many health organizations world-wide. This paper discusses the BMD methods and corresponding software (i.e., BMDS version 2.1.1) that have been developed by the U.S. EPA, and includes a comparison with recently released European Food Safety Authority (EFSA) BMD guidance. Published by Elsevier Inc.