一种最小的方法来证明数字和传统显微镜在毒理病理学病理学中的一致性
Charlotte Lempp1, Stefanie Arms1, Christof Albert Bertram2
1Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riß, Germany.
Toxicologic pathology
|June 3, 2024
概括
数字病理学幻灯片被验证用于非临床安全评估. 这项研究表明,数字幻灯片评估在毒理病理学中适合目的,支持监管适应.
科学领域:
- 数字病理学数字病理学
- 毒理学病理学的毒理学病理学
- 监管科学是一种监管科学.
背景情况:
- 数字病理学在诊断中已经建立,但由于有限的监管指导和良好实验室实践 (GLP) 验证,在非临床安全方面面临挑战.
- 数字幻灯片验证的比较研究存在于兽医和人类诊断方面,但不存在于毒理病理学方面.
- 缺乏确定的验证,阻碍了在监管毒理学中采用数字病理学.
研究的目的:
- 提出一种方法,用于在非临床安全研究中统计比较数字和玻璃幻灯片一致性.
- 为了证明数字幻灯片适合用于毒理病理学评估的目的.
- 支持数字病理学在监管领域的全面适应.
主要方法:
- 使用来自非临床安全研究的研究材料.
- 使用基准研究设计进行统计比较.
- 在对比研究期间,尽量减少人员的时间和精力.
主要成果:
- 数字幻灯片评估被证明是适合非临床安全评估的目的.
- 实现了玻璃和数字幻灯片之间的一致率的统计比较.
- 这种方法最大限度地减少了资源利用.
结论:
- 数字病理学评估适用于非临床安全评估.
- 这些发现支持在监管环境中成功验证数字病理学工作流程.
- 在监管毒理学中完全适应数字病理学是可行的,并建议.
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