Applications of model-informed drug development (MIDD) on new drug research and development
10.12092/j.issn.1009-2501.2020.01.001
- VernacularTitle: 模型引导的药物开发在新药研发中的应用
- Author:
Jian LI
1
Author Information
1. Center of Drug Evaluation, National Medical Products Administration
- Publication Type:Journal Article
- Keywords:
Dose optimization;
Exposure-response relationship;
Model-informed drug development (MIDD);
New drug;
Pharmacokinetics/pharmacodynamics (PK/PD);
Population pharmacokinetics
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2020;25(1):1-8
- CountryChina
- Language:Chinese
-
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.
