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中国临床药理学与治疗学 ›› 2020, Vol. 25 ›› Issue (1): 1-8.doi: 10.12092/j.issn.1009-2501.2020.01.001

• 专论 •    下一篇

模型引导的药物开发在新药研发中的应用

李 健,杨进波,王玉珠   

  1. 国家药品监督管理局药品审评中心,北京 100022
  • 收稿日期:2020-01-10 修回日期:2020-01-13 出版日期:2020-01-26 发布日期:2020-02-11
  • 通讯作者: 王玉珠,女,博士,研究员,高级审评员,主要从事临床药理技术审评工作。 Tel:010-85243204 E-mail: wangyzh@cde.org.cn
  • 作者简介:李健,博士,助理研究员,主要从事临床药理技术审评工作。 Tel: 010-85243199 E-mail: lijian@cde.org.cn

Applications of model-informed drug development (MIDD) on new drug research and development

LI Jian, YANG Jinbo, WANG Yuzhu   

  1. Center of Drug Evaluation, National Medical Products Administration, Beijing 100022, China
  • Received:2020-01-10 Revised:2020-01-13 Online:2020-01-26 Published:2020-02-11

摘要: 模型引导的药物开发(MIDD)通过应用各类数学模型进行定量分析,从而指导新药开发和决策。MIDD在先进药物研发企业中的研发决策应用,以及先进监管部门的监管决策尤其美国FDA的应用,已较为普遍和成熟,但在国内创新药研究中的普及率还相对较低。本文根据作者实际工作经验,基于当前新药临床药理专业审评中常见的模型研究内容和有代表性的案例,结合国内外MIDD相关技术指导原则,对MIDD的主要应用范畴进行了探讨,并简要讨论了MIDD应用于新药研发的几点建议和注册申报的一般考虑,供新药开发企业和研究者讨论或参考。

关键词: 新药, 模型引导的药物开发, 量效关系, 剂量优化, 群体药代动力学, 药代动力学/药效动力学

Abstract: Model-informed drug development (MIDD) refers to the application of various mathematical models in drug development, in order to facilitate the decision-making process. There have been common and mature applications of MIDD to address drug development and regulatory questions in interactional industries and advanced regulatory agencies, especially the US FDA. However, its application in innovative drug development is relatively rare in China. Representative case studies, clinical pharmacology review ex-periences, and relevant guidelines are reviewed in this article to present a preliminary discussion on the main applications of MIDD. Additionally, several suggestions for the application of MIDD in new drug development as well as general considerations for new drug registration are proposed in this paper, for the discussion or reference of industries and researchers.

Key words: new drug, model-informed drug development (MIDD), exposure-response relationship, dose optimization, population pharmacokinetics, pharmacokinetics/pharmacodynamics (PK/PD)

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