模型引导方法助力我国创新药物监管决策  

Model-Informed Approach Supporting Innovative Drug Evaluation and Regulatory Decision-Making in China

作　　者：魏春敏 高丽丽 贺锐锐 王骏[1] WEI Chun-min;GAO Li-li;HE Rui-rui;WANG Jun(Center for Drug Evaluation,National Medical Products Administration)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国食品药品监管》2024年第4期14-19,共6页China Food & Drug Administration Magazine

摘　　要：模型引导的药物研发(MIDD)已被广泛应用于创新药物研发不同阶段。2020年12月,国家药品监督管理局药品审评中心发布《模型引导的药物研发技术指导原则》,鼓励申请人在药物研发全生命周期合理使用建模与模拟技术方法,同时也全面开启了MIDD方法在药品监管决策中的应用。本文梳理了MIDD方法为药品审评中面临的创新药物临床试验剂量选择、风险获益评估、儿科人群剂量外推、特殊人群剂量调整、药物相互作用评估等方面提供支持信息的重点案例,以期引导和进一步推动建模与模拟技术方法在我国创新药品监管决策中的应用,提升药品监管决策效率。Model-informed drug development(MIDD)has been widely used in different stages of innovative drug development.The Guidance for Model-Informed Drug Development was issued by the Center for Drug Evaluation of National Medical Product Administration in December 2020.It not only encourages applicants to rationally use modeling and simulation methods throughout the whole lifecycle of drug development,but also prompts reviewers to make decisions supported by MIDD.This article mainly presents cases of model-informed approach supporting drug development and regulatory evaluation in areas such as dose selection for clinical trials of innovative drugs,risk-benefit assessment,pediatric extrapolation,dose adjustment for special populations,and assessment of drug-drug interactions.It aims to further promote the application of modeling and simulation in innovative drug development and enhance the efficiency of drug review and regulatory decision-making.

关 键 词：模型引导的药物研发 剂量优化 风险获益 儿科外推 药物相互作用 

分 类 号：R95[医药卫生—药学]