动物试验的替代方案,以评估MASH药物和肝毒性
1Sanford Burnham Prebys and UC San Diego, La Jolla, California, USA.
Hepatology (Baltimore, Md.)
|November 7, 2023
概括
美国食品和药物管理局 (FDA) 现代化法案2.0为药物开发提供了动物试验的替代方案. 基于人类肝脏的新平台为动物研究提供了有前途的替代方案,用于评估药物安全性和有效性,特别是在MASH等肝脏疾病中.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 药物开发 药物开发
- 毒理学 毒理学 毒理学
背景情况:
- 美国食品和药物管理局 (FDA) 现代化法案2.0允许在药物和生物产品应用中使用动物试验的替代方案.
- 传统的二维肝细胞培养不能充分复制肝功能或疾病状态.
- 对于药物评估而言,急需可靠的体外模型.
研究的目的:
- 审查和评估新兴的人类肝脏平台作为动物试验的替代品.
- 评估这些平台在评估药物肝毒性方面的潜力.
- 探索它们在创建肝病治疗的"盘中的疾病"模型中的实用性,重点是MASH.
主要方法:
- 技术方法的审查,包括精密切割的肝脏切片,人类肝脏球体和器官.
- 对生物打印的人类肝脏组织和微生理系统的评估.
- 对基于人类肝细胞的平台进行药物疗效和毒性研究的评估.
主要成果:
- 几种使用人类肝细胞的先进平台正在开发中.
- 这些技术的目的是与2D培养相比,更好地模仿肝脏生理和疾病表型.
- 审查的平台显示了评估药物诱导的肝损伤和治疗疗效的潜力.
结论:
- 新兴的基于人类肝脏的技术为药物评估提供了对动物试验的可行替代方案.
- 这些平台对于推动开发更安全,更有效的肝病治疗方法至关重要.
- 这些模型的进一步开发和验证对于监管接受和临床转化至关重要.
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