530种药物的非临床和临床IUCLID数据库 (第一部分):其开发的方法方面
Martina Evangelisti1, Marco Daniele Parenti2, Greta Varchi3
1Innovamol Consulting Srl, Via San Faustino 167, 41126, Modena, Italy.
Regulatory toxicology and pharmacology : RTP
|May 30, 2023
概括
一个新的IUCLID数据库提供了530种药物的动物和人类研究中的关键毒性数据. 该资源有助于药物安全性评估和开发非动物测试替代品.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 药物安全评估 药物安全评估
- 计算生物学 计算生物学
背景情况:
- 现有的药物毒性数据库缺乏用于相关性分析的全面,标准化数据.
- 越来越需要强大的数据集来支持非动物测试策略和阐明药物机制.
研究的目的:
- 创建一个新的IUCLID数据库,整合530种已批准药物的非临床动物和人类数据.
- 开发一种补充的实体学,用于对毒理学影响的标准化报告,特别是生殖和内分泌终点.
- 为了促进药物安全性和机制阐明的相关性和一致性分析.
主要方法:
- 从重复剂量,致癌性,发育和生殖毒性研究的药理学审查中提取数据.
- 从已批准的药物产品标签中包括人体效应数据.
- 基于现有的表型本体学,开发一个专业的本体学,用新的毒理学效应术语来增强它.
主要成果:
- 一个全面的IUCLID数据库,包含530种药物的详细毒性信息,将观察到的/未观察到的影响与严重程度,发生率和可逆性联系起来.
- 一个先进的本体学,用于报告毒理效应的标准化术语,包括生殖和内分泌终点的独特术语.
- 数据库和本体论是免费提供的,可以通过公共URL访问.
结论:
- 新的数据库和本体学为制药行业和研究人员提供了强大的资源.
- 本综合资源支持开发替代非动物方法,并增强对药物毒性机制和人类相关性的理解.
- 该本体学有助于分析毒理学数据,特别是生殖和内分泌影响,并可用于遗留数据编码.
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