Barton Hugh A, Pastoor Timothy P, Baetcke Karl, Chambers Janice E, Diliberto Janet, Doerrer Nancy G, Driver Jeffrey H, Hastings Charles E, Iyengar Seshadri, Krieger Robert, Stahl Bernhard, Timchalk Charles
U.S. Environmental Protection Agency, National Centerfor Computational Toxicology, Research Triangle Park, North Carolina, USA.
Crit Rev Toxicol. 2006 Jan;36(1):9-35. doi: 10.1080/10408440500534362.
A proposal has been developed by the Agricultural Chemical Safety Assessment (ACSA) Technical Committee of the ILSI Health and Environmental Sciences Institute (HESI) for an improved approach to assessing the safety of crop protection chemicals. The goal is to ensure that studies are scientifically appropriate and necessary without being redundant, and that tests emphasize toxicological endpoints and exposure durations that are relevant for risk assessment. Incorporation of pharmacokinetic studies describing absorption, distribution, metabolism, and excretion is an essential tool for improving the design and interpretation of toxicity studies and their application for safety assessment. A tiered approach is described in which basic pharmacokinetic studies, similar to those for pharmaceuticals, are conducted for regulatory submission. Subsequent tiers provide additional information in an iterative manner, depending on pharmacokinetic properties, toxicity study results, and the intended uses of the compound.
国际生命科学研究所健康与环境科学学会（HESI）的农业化学品安全评估（ACSA）技术委员会已制定了一项提案，旨在改进作物保护化学品安全性评估方法。目标是确保研究在科学上恰当且必要，避免冗余，并且测试着重于与风险评估相关的毒理学终点和暴露持续时间。纳入描述吸收、分布、代谢和排泄的药代动力学研究是改进毒性研究设计与解读及其在安全评估中应用的重要工具。文中描述了一种分层方法，即进行类似于药物的基础药代动力学研究以供监管申报。后续层次根据药代动力学特性、毒性研究结果和化合物的预期用途，以迭代方式提供更多信息。
