模型引导的药物研发:发展历程和应用思考  

Model-informed drug development: History and application

作　　者：周舟 刘波 ZHOU Zhou;LIU Bo(Department of Modeling and Simulation,Hubei Yinghan Pharmaceutical Technology Co,Ld.,Huangshi 435000,Hubei Province,China;School of Chemical Engineering and Pharmacy,Wuhan Institute of Technology,Wuhan 430000,Hubei Province,China)

机构地区：[1]湖北英翰医药科技有限公司模拟与仿真,湖北黄石435000 [2]武汉工程大学化工与制药学院,湖北武汉430000

出　　处：《中国临床药理学杂志》2021年第6期772-776,787,共6页The Chinese Journal of Clinical Pharmacology

摘　　要：使用模型和模拟(M&S)有助于提高药品研发的决策质量和效率,为监管评估提供客观证据,通过应用实例、指南颁布和政策推动。模型引导的药物研发(MIDD)已经受到越来越多制药企业和监管机构的认可和支持。本研究旨在鼓励研究者认识和理解MIDD在药物研究和法规中的作用和应用价值。Modelling & simulation(M&S) is helpful to improve the decision quality and efficiency of drug development and provides objective evidence for regulatory evaluation, through practical examples, establishment of guidelines and programs. Model-informed drug development(MIDD) has gained wide recognition and support from pharmaceutical companies and regulatory agencies. This review intend to encourage researchers to understand the purpose and value of MIDD in drug development and regulatory guidelines.

关 键 词：模型和模拟 学习和验证 基于生理的药代动力学模型 模型引导的药物研发 

分 类 号：R97[医药卫生—药品]