Practice of model-informed drug development in pharmaceutical in-dustry in China
李健 1王玉珠 1王骏1
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作者信息
1. 国家药品监督管理局药品审评中心,北京 100076
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摘要
2020年,国家药品监督管理局颁布了《模型引导的药物研发技术指导原则》等技术指南,为建模与模拟技术在新药研发中的应用提供了技术指导.2022年7月,为了解国内新药研发企业在模型引导的药物研发(model-informed drug development,MIDD)方面的实践情况,药品审评中心对制药工业界在新药研发中应用MIDD的实践能力进行了问卷调查.本文主要针对收集到的企业反馈数据,分析MIDD技术在国内制药工业界的实践情况,并对当前仍存在的部分问题进行简要讨论.
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.
关键词
模型引导的药物研发/调查问卷/工业界/应用实践/专业团队
Key words
model-informed drug development/questionnaire survey/pharmaceutical industry/prac-tice/professional group
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