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

doi:10.12092/j.issn.1009-2501.2020.01.001

Abstract

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)

CLC Number:

R969

LI Jian, YANG Jinbo, WANG Yuzhu. Applications of model-informed drug development (MIDD) on new drug research and development[J]. Chinese Journal of Clinical Pharmacology and Therapeutics, 2020, 25(1): 1-8.

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