类器官技术在新药评价中的应用进展
Progress in application of organoids technique in new drug evaluation
王俊龙 1傅丽霞 2王青洋 3王磊 1赵丹丹 1田茹 1刘莉 1崔一民2
作者信息
- 1. 中国医药工业研究总院,上海 200437
- 2. 北京大学第一医院临床药理研究所,北京 100191
- 3. 上海市药品监督管理局,上海 200233
- 折叠
摘要
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.
Abstract
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.
关键词
类器官/器官芯片/生物3D打印/新药评价/政策法规Key words
organoid/organ-on-chip/3D bioprinting/new drug evaluation/policies and regulations引用本文复制引用
出版年
2024
NETL
NSTL
万方数据