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Chinese Journal of Clinical Pharmacology and Therapeutics ›› 2024, Vol. 29 ›› Issue (5): 596-600.doi: 10.12092/j.issn.1009-2501.2024.05.016

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Practice of model-informed drug development in pharmaceutical industry in China

LI Jian, WANG Yuzhu, WANG Jun   

  1. Center of Drug Evaluation, National Medical Products Administration, Beijing 100076, China
  • Received:2023-12-20 Revised:2024-01-25 Online:2024-05-26 Published:2024-04-16

Abstract:

Guideline of model-informed drug development 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 development. In July 2022, Center of Drug Evaluation conducted a questionnaire survey on the practical ability of pharmaceutical industry to apply model-informed 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.

Key words: model-informed drug development, questionnaire survey, pharmaceutical industry, practice, professional group

CLC Number: