现代毒理学中的复杂性导航:在体内短期研究中Omics的作用
Constance A Mitchell1, Leah Wehmas2, David Rouquie3
1Health and Environmental Sciences Institute, Washington, DC, USA.
概括
毒理学正在从短期研究中获得有关人类风险的预测数据. 这些下一代风险评估 (NGRA) 方法通过整合分子数据来更好地识别危险,从而减少动物试验.
科学领域:
- 毒理学和风险评估
- 分子毒理学
- 监管科学
背景情况:
- 毒理学领域正在转向基于机制的预测方法.
- 在短期体内研究中的Omics终点提供了早期分子毒性指标.
- 这些方法旨在减少对传统动物试验的依赖,以更快速地对人类进行相关的风险评估.
研究的目的:
- 总结有关技术进步与下一代风险评估 (NGRA) 的监管需求的见解.
- 强调在NGRA框架中对各种产品行业的数据的重要性.
- 讨论短期机械动物研究作为新方法方法 (NAM) 的桥梁.
主要方法:
- 使用短期体内研究的奥米克数据 (例如,转录组,蛋白质组).
- 导出分子起点 (mPOD) 和其他生物定指标.
- 从毒理学学会 (SOT) 关于omics-enabled NGRA会议的见解进行总结.
主要成果:
- 数据生成,分析和解释已经显著成熟.
- 来自omics数据的生物定指标可以为强度排名和危险识别提供信息.
- NGRA框架需要根据各个部门的具体监管要求和曝光环境进行调整.
结论:
- 支持Omics的危险概况具有支持NGRA的巨大潜力.
- 标准化生物信息学,与主要终点进行验证和扩大培训是关键的挑战.
- 协作科学和灵活的监管框架对于实现毒理学中omics的全部潜力至关重要.
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