将基于成像的体外方法从生物医学研究桥接到监管毒理学
Monica Piergiovanni1, Milena Mennecozzi2, Erio Barale-Thomas3
1European Commission, Joint Research Centre (JRC), Ispra, Italy. monica.piergiovanni@ec.europa.eu.
Archives of toxicology
|February 13, 2025
概括
图像技术为监管毒理学提供与人类相关的数据. 图像分析,人工智能和数据管理方面的挑战必须得到解决,以便在体外方法得到全球接受.
科学领域:
- 生物医学研究的研究.
- 实验性毒理学 试验性毒理学
- 在体外 (in vitro) 方法.
背景情况:
- 图像技术对于在生物医学研究和毒理学中从细胞模型中收集形态和功能数据至关重要.
- 有一个重要的机会将基于成像的体外方法纳入国际监管合规指南.
- 翻译这些方法需要解决质量管理,实验室间可转移性和数据可靠性.
研究的目的:
- 总结监管毒理学的基于成像的方法的当前挑战.
- 讨论图像采集,分析 (包括人工智能) 和数据管理的解决方案.
- 为未来的验证和可转移性研究提供考虑因素.
主要方法:
- 审查基于成像的方法当前的挑战.
- 发育性神经毒性的实验室电池和表型分析分析的例子.
- 讨论质量管理,实验室间可转移性和数据稳定性.
主要成果:
- 识别了图像采集,人工智能驱动的图像分析和数据管理方面的挑战.
- 强调需要标准化的协议和质量系统.
- 强调了实验室间可转移性对于监管接受的重要性.
结论:
- 解决成像,分析和数据管理方面的挑战是监管接受的关键.
- 实施强大的质量管理系统对于可靠的体外数据至关重要.
- 需要进一步的验证和可转移性研究,以支持全球采用基于成像的毒理学方法.
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