Practice of model-informed drug development in pharmaceutical in-dustry in China
10.12092/j.issn.1009-2501.2024.05.016
- VernacularTitle:模型引导的药物研发技术在国内制药工业界的实践情况
- Author:
Jian LI
1
;
Yuzhu WANG
;
Jun WANG
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076
- Keywords:
model-informed drug development;
questionnaire survey;
pharmaceutical industry;
prac-tice;
professional group
- From:
Chinese Journal of Clinical Pharmacology and Therapeutics
2024;29(5):596-600
- CountryChina
- Language:Chinese
-
Abstract:
Guideline of model-informed drug de-velopment was published by National Medical Products Administration in 2020,which provided technical guidance for the application of modeling and simulation in the process of new drug develop-ment.In July 2022,Center of Drug Evaluation con-ducted a questionnaire survey on the practical abili-ty of pharmaceutical industry to apply model-in-formed drug development(MIDD)in the process of new drug development,in order to investigate the practice of MIDD in China.Based on the feedback data collected from enterprises,this paper analyzes the practice of MIDD in domestic pharmaceutical industry,and briefly discusses several problems that still exist at present.
