另一种安全分析算法 (ASPA) 将下一代风险评估转化为结构化和透明的过程.
Marcel Leist1,2, Silvia Tangianu1,2, Femke Affourtit3
1In vitro Toxicology and Biomedicine, Dept inaugurated by the Doerenkamp-Zbinden foundation, University of Konstanz, Konstanz, Germany.
ALTEX
|October 16, 2025
概括
下一代风险评估 (NGRA) 使用无动物新方法方法 (NAM) 进行化学安全. 替代安全分析算法 (ASPA) 为将NAM数据整合到风险评估中提供了一个标准化,可重复的工作流程.
科学领域:
- 毒理学和化学安全
- 计算毒理学计算毒理学
- 监管科学 监管科学
背景情况:
- 下一代风险评估 (NGRA) 依赖于无动物新方法方法 (NAM) 对危险,毒动力学 (ADME) 和暴露数据.
- 目前的NGRA数据收集,整合和报告流程缺乏标准化,阻碍了可复制性和透明度.
- 标准化对于化学品风险评估和分类的一致决策至关重要.
研究的目的:
- 引入替代安全分析算法 (ASPA),为NGRA提供透明和可重复的工作流程.
- 为了实现NGRA所需的多种数据类型的集成和文档.
- 为监管目的确保安全评估的可追溯性和可重复性.
主要方法:
- ASPA 正式化了NGRA的数据收集,集成和报告.
- 工作流程通过记录所有步骤,决策和理由来强调透明度.
- ASPA包括对不确定性和数据相互依赖性的监测和评估.
- 相关的ASPA辅助软件通过标准化报告流程指导用户.
主要成果:
- ASPA为化学安全评估提供了可追溯和可重复的工作流程.
- 该ASPA-assist软件有助于组装详细的数据,方法和决策的综合报告.
- 案例研究表明ASPA在各种监管环境和问题制定中的适用性.
结论:
- ASPA增强了NGRA的标准化和可重复性.
- 该算法确保相同的数据输入导致独立评估者之间一致的结果.
- ASPA及其支持软件提高了化学风险评估过程的透明度和可靠性.
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