Practice of model-informed drug development in pharmaceutical in-dustry in China / 中国临床药理学与治疗学

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.