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药物开发中的模型信息化范式 - - 一个从Upadacitinib开发的端到端的案例研究

Sumit Bhatnagar¹, Sven Stodtmann¹, Yuli Qian¹

¹Clinical Pharmacology, AbbVie Inc., North Chicago, Illinois, USA.

Clinical and translational science

|August 5, 2025

概括

基于模型的药物开发 (MIDD) 从早期试验到批准后成功指导了upadacitinib计划. 本案例研究强调了MIDD如何提高药物开发的效率和决策.

科学领域:

制药指标 (Pharmacometrics) 是一个指标.
量化药理学量化药理学
药物开发科学药物开发科学

背景情况:

基于模型的药物开发 (MIDD) 使用定量方法来增强药物开发决策.
在制药行业成本上升和竞争中,MIDD对于提高效率至关重要.
乌帕达西尼布是一种口服的选择性Janus激酶抑制剂,已被批准用于多种炎症条件.

研究的目的:

在upadacitinib开发计划中描述一个成功的MIDD应用的独特案例.
介绍建模和模拟在为upadacitinib的关键开发决策提供信息方面的应用和影响.
为其他药物开发计划提供一个框架,基于从upadacitinib.com获得的经验教训.

主要方法:

应用定量建模和模拟方法.
整合MIDD从第一阶段临床试验到后审批阶段.
分析MIDD在upadacitinib计划中的决策过程.

主要成果:

在整个upadacitinib开发生命周期中证明了MIDD的成功应用.
临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床临床
在各种指示中成功批准了upadacitinib的监管批准得到了MIDD的支持.

结论:

乌帕达西提尼布 (upadacitinib) 计划是MIDD.的成功整合和影响的一个例子.
MIDD为高效和有效的药物开发提供了有价值的框架.
从upadacitinib中吸取的经验教训可以指导未来使用MIDD的药物开发策略.

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