首页|类器官技术在新药评价中的应用进展

类器官技术在新药评价中的应用进展

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类器官是一种利用胚胎干细胞、成体干细胞或多能干细胞进行体外三维培养而形成的具有一定空间结构的组织类似物,能高度模拟体内组织结构及功能,并展现出与人体器官极为相似的组织学和基因型特征.类器官的兴起和发展为医学研究开辟了新途径,尤其是在新药评价方面展现出良好的发展前景和广阔的应用潜力,因此受到了各界人士的广泛关注.本文将探讨类器官在新药评价中的应用情况,包括临床前研究、临床试验中的应用现状及药品监管机构相关政策法规现状,以期为类器官在新药评价中的研究与应用提供参考.
Progress in application of organoids technique in new drug evaluation
Organoids are tissue analogues with certain spatial structures formed by three-dimensional culture of embryonic stem cells,adult stem cells or pluripotent stem cells in vitro,which can highly simulate the structure and function of tissues in vivo,and have similar histological and genotypic characteristics to human organs.The rise and development of organoids have opened up a new path for medical research,especially in the evaluation of new drugs,showing good development prospects and broad application potential,so attracting widespread attention from people from all walks of life.This paper discusses the application of organoids in the evaluation of new drugs,including the application status of preclinical studies,clinical trials,and relevant policies and regulations of drug regulatory agencies,in order to provide references for the research and application of organoids in the field of new drug evaluation.

organoidorgan-on-chip3D bioprintingnew drug evaluationpolicies and regulations

王俊龙、傅丽霞、王青洋、王磊、赵丹丹、田茹、刘莉、崔一民

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中国医药工业研究总院,上海 200437

北京大学第一医院临床药理研究所,北京 100191

上海市药品监督管理局,上海 200233

类器官 器官芯片 生物3D打印 新药评价 政策法规

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(20)