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干细胞衍生器官作为下一代药物毒性和有效性测试平台:在监管科学中取代动物模型

Sungmin Kim¹, Taeho Lee², Mingu Ryu²

¹School of Cellular and Molecular Medicine, University of Bristol, Bristol, UK.

Journal of applied toxicology : JAT

|January 13, 2026

概括

有机体,自我组织的干细胞结构,正在彻底改变临床前药物开发. 这些人体组织模型为药物安全性和疗效测试提供了卓越的准确性,减少了对动物模型的依赖.

科学领域:

生物技术是生物技术.
再生医学是一种再生医学.
药物发现药物发现药物发现

背景情况:

器官体是3D干细胞衍生结构,模仿人类组织.
传统的二维培养和动物模型在临床前测试中存在局限性.
监管机构越来越认识到对新方法方法 (NAM) 的需求.

研究的目的:

审查有机体技术及其在临床前药物测试中的应用.
检查用于建模器官毒性的方法,并加强使用个性化器官的有效性测试.
讨论有关有机体标准化和验证的监管途径.

主要方法:

审查有关有机体开发和应用的当前文献.
在模拟肝脏,脏和心脏中有毒反应中对有机物使用的分析.
探索个性化和特定疾病的有机体策略.
审查监管格局和标准化工作.

主要成果:

器官类药物为药物安全性和有效性提供准确的人体组织表示.
个性化和特定疾病的器官可提高测试准确度.
与微工程和人工智能的整合增强了有机体的实用性.
挑战包括生物变异性,标准化和道德考虑.

结论:

器官技术为临床前药物开发提供了重大进步.
有机器人提供人类特异性的数据,减少了动物试验.
标准化和监管部门的批准对于广泛采用至关重要.
有机体集成有望改变药物发现和安全性评估.

关键词:

没有动物的模型.药物疗效评估药物的疗效评估.有机生物有机物监管科学是一种监管科学.毒性测试毒性测试毒性测试

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