首页|类器官技术在药物评价中的应用进展

类器官技术在药物评价中的应用进展

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近年来类器官和器官芯片技术发展迅速.类器官具有近生理性、人源性、遗传稳定性、高通量、易操作等优势,与器官芯片技术结合,可广泛应用于药物开发、药物评价、再生医疗等多个领域.类器官技术在药物评价中的应用包括药效动力学、药物代谢动力学、药物有效性和安全性等,其中在非临床药效学评价中的应用发展较快.文章介绍了类器官技术及其代表性模型在药物评价中的应用,综述了国际监管政策和行业发展现状,简介了应用案例,并对类器官和器官芯片技术用于非临床替代或补充模型的应用和挑战进行了讨论.
The Application Development of Organoids for Drug Evaluation
In recent years,organoids and organ chips have been developed rapidly.Organoids show certain advantages such as physiological,human origin,genetic stability,high throughput and easy operation,and can be widely used in many fields including drug development,drug evaluation and regenerative medicine.The application of organoids to drug developing include the evaluation of pharmacodynamics,pharmacokinetics,effectiveness and safety,especially for non-clinical pharmacodynamic evaluation.Here,the applications of organoids and their representative models in drug evaluation are introduced,the regulatory international regulatory policy and industry developments are briefly reviewed.Finally,the applications and challenges of organoids and organ chips for non-clinical alternative or complementary models are discussed.

organoidorgan chipdrug evaluationnon-clinical pharmacodynamic evaluationresearch progress

董文彬、李慧、陈一飞

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复旦大学药学院,上海 201203

复旦大学附属中山医院,上海 200032

上海药品审评核查中心,上海 201203

类器官 器官芯片 药物评价 非临床药效学评价 研究进展

2024

中国医药工业杂志
上海医药工业研究院,中国化学制药工业协会

中国医药工业杂志

CSTPCD
影响因子:0.487
ISSN:1001-8255
年,卷(期):2024.55(5)
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