IHI VICT3R:开发和实施虚拟控制小组,以减少毒理学研究中的动物使用
Thomas Steger-Hartmann1, Ferran Sanz2, Frank Bringezu3
1Bayer AG, Pharmaceuticals, Berlin, Germany.
Toxicologic pathology
|December 12, 2024
概括
VICT3R项目旨在从历史的动物毒性数据中创建虚拟控制组 (VCG). 这种方法旨在减少和取代动物研究中的并发控制,增强伦理研究实践.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 计算生物学 计算生物学
- 监管科学 监管科学
背景情况:
- 虚拟控制组 (VCG) 概念重新利用历史的动物毒性数据来减少研究中的并发控制.
- 之前的工作确立了VCG的可行性,但实施需要大量的合作努力.
- 对VCGs的监管接受仍然是一个关键的挑战.
研究的目的:
- 为了应对VCG实施的挑战,并获得监管机构的接受.
- 建立一个高质量的,标准化的数据库,对毒性研究中的对照动物数据.
- 开发工作流程和计算工具,以生成强大的VCGs.
主要方法:
- 将历史和未来的控制动物数据编制和标准化为一个全面的数据库.
- 开发统计和人工智能 (AI) 方法来生成虚拟对照动物.
- 通过与真实对照组进行比较,评估VCG的有效性,可重复性和稳定性.
主要成果:
- VICT3R项目正在建立一个强大的数据库,用于VCG生成.
- 工作流和人工智能工具正在开发中,以创建统计学上合理的VCGs.
- 正在进行验证研究,将VCG的表现与传统的对照组进行比较.
结论:
- VICT3R项目正在推动VCG概念向实际应用和监管接受的方向发展.
- 该倡议旨在显著减少在毒性测试中使用动物.
- 该项目将提供验证的工具和数据,用于生成可靠的虚拟控制组.
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