首页|临床试验模拟中虚拟患者的概念和模型与案例

临床试验模拟中虚拟患者的概念和模型与案例

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虚拟患者是临床试验模拟中通过建模与模拟产生的受试者,用于预测评估干预措施的安全性和有效性,从而提供临床试验不同阶段发展的趋向性并预测成功率,避免资源的浪费,同时模拟的结果也可作为证据支撑临床决策。历经20 年的发展,虚拟患者的构建和应用不断完善,获得了国际社会广泛的关注与认可。本文通过整理现阶段虚拟患者研究的相关文献,在总结构建虚拟患者的模型及分类的基础上,以临床试验模拟中不同生理学层级上的虚拟患者为例,探讨其构建的目的、应用及局限性,旨在帮助研究者更好地了解该技术及其在药物研发领域的价值和意义。
Virtual patient in clinical trial simulation:concepts,models and cases
Virtual patients are subjects generated by modeling and simulation in clinical trial simulation,which are used to evaluate and predict the safety and effectiveness of interventions.Virtual patients can provide not only the development trends of clinical trials at different stages but also the possibility of success rates,which may effectively avoid the waste of resources and produce some evidence to support decision making.After 20 years of development,the construction and application of virtual patient have been continuously improved,which has been widely recognized by the international community.This paper sorted out the current literature on virtual patients,summarized the models that construct virtual patients and their classification,and discussed the purpose,application and limitation of virtual patients taking virtual patients at different physiological levels in clinical trial simulation as example,in order to help researchers better understand this technology and its value and significance in the field of drug development.

virtual patientvirtual physiological human modelclinical trial simulationmodel-informed drug development

王思村、陈亚飞、顾浩、党海霞、刘骏、王忠、于亚南

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中国中医科学院中医临床基础医学研究所,北京 100700

中国中医科学院数据中心,北京 100700

中国中医科学院,北京 100700

虚拟患者 虚拟生理人模型 临床试验模拟 模型引导的药物研发

国家自然科学基金资助项目中国中医科学院科技创新工程资助项目中国中医科学院院级第十四批自主选题资助项目

82105052CI2021A04707Z0720

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(9)
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