虚拟人类安全评估平台 (VHP4Safety) 项目:基于人类数据的下一代化学安全评估
Anne Kienhuis1,2, Cyrille Krul3, Jacqueline van Engelen1
1Center for Health Protection, RIVM, National Institute for Public Health and the Environment, Bilthoven, The Netherlands.
ALTEX
|October 13, 2024
概括
安全评估虚拟人体平台 (VHP4Safety) 项目正在开发一个虚拟人体平台 (VHP),以取代动物测试. 这项合作倡议整合了各种数据和方法,用于先进的化学和制药安全评估.
科学领域:
- 毒理学和计算生物学
- 监管科学是一种监管科学.
- 人类健康风险评估评估 人类健康风险评估
背景情况:
- 传统的安全评估严重依赖于动物试验,这在预测人类反应方面存在局限性.
- 在化学和制药安全评估中,越来越需要以人为本的方法.
- "VHP4Safety"项目通过创建一个全面的虚拟人类平台来满足这一需求.
研究的目的:
- 介绍VHP4Safety项目及其跨学科,共同创作的方法.
- 概述虚拟人类平台 (VHP) 的开发和实施战略.
- 为了证明VHP的潜力,彻底改变安全评估和减少动物试验.
主要方法:
- 使用诸如药理动力学和计算模型等工具构建VHP.
- 整合不同的人类数据来源 (生理学,流行病学,毒动学) 和化学数据.
- 使用新方法方法 (NAM) 来表示VHP中的不良结果途径.
- 采用创新系统方法实施VHP,包括利益相关者参与和培训.
- 通过与30多个合作组织的设计马拉松和黑客马拉松促进共同创作.
主要成果:
- VHP集成了多个数据流和建模工具来模拟与人类相关的安全场景.
- 三个案例研究用于测试和完善特定应用的VHP.
- 该项目促进跨学术,监管,工业和社会部门的合作.
- 新的方法方法正在被整合起来,以捕捉不利结果途径中的关键事件.
结论:
- "VHP4Safety"项目正在建立一个虚拟人类平台 (VHP),以推进以人为基础的安全评估.
- 该项目的共同创意和跨学科方法对其成功至关重要.
- VHP有潜力显著减少对化学和制药安全的动物试验的依赖.
- 这一举措为下一代安全评估策略铺平了道路.
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