复杂的体外模型对药物测试的影响进行定位:对药物测试的审查
Serah Kang1, Eugene C Chen2, Helen Cifuentes1
1Complex in vitro Systems Group, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, United States of America.
复杂的体外模型 (CIVMs) 显示出药物开发的前景,减少动物使用. 本综述提供了一个框架,使用模型学和使用上下文分析来评估CIVM对药物应用的准备.
科学领域:
- 药理学 药理学是指药理学的学科.
- 生物技术是生物技术.
- 毒理学 毒理学 毒理学
背景情况:
- 复杂的体外模型 (CIVM),包括器官和芯片上的器官,正在成为制药研究中动物试验的替代品.
- 美国食品和药物管理局现代化法案2.0提高了公众和行业对CIVM的认识,推动了潜在的投资和采用.
- 需要标准化框架来评估CIVM对药物开发的准备程度,并评估它们对特定测试的适用性.
研究的目的:
- 提出用于药物开发的CIVM选择和资格的框架.
- 评估当前健康组织CIVM对10个关键器官的准备情况.
- 为改善CIVM在制药行业的开发和应用提供路线图.
主要方法:
- 基于对比的 -omics数据 (模型-omics) 的框架的开发,用于CIVM的评估.
- 定义用于合格特定测试试验的指标 (使用上下文或COU试验).
- 对十个药物开发关键器官的现有健康组织模型和分析的调查和评估.
主要成果:
- 该审查提供了对当前CIVM准备程度的评估,以及对药物开发的测试.
- 为增强特定器官模型的模型-omics数据和COU测定提供了建议.
- 该框架旨在指导最终用户和开发人员有效利用CIVM.
结论:
- CIVM 具有显著的潜力,可以提高药物安全性和疗效,同时减少动物使用.
- 拟议的模型-omics和COU测定框架可以促进CIVMs在药物开发管道中的整合.
- 进一步开发和标准化CIVM对于实现其在制药研究中的全部影响至关重要.
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