Model‐Informed Paradigm in Drug Development—An End‐To‐End Case Study From Upadacitinib Development

ABSTRACT Model‐informed drug development (MIDD) entails applying quantitative approaches to assist with decision‐making during drug development and has been used for dose optimization, to inform clinical trial design, and to support clinical trial waivers. With increasing cost and competitiveness in...

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Bibliographic Details
Main Authors: Sumit Bhatnagar, Sven Stodtmann, Yuli Qian, Patrick Marroum, Wei Liu, Mohamed‐Eslam F. Mohamed
Format: Article
Language:English
Published: Wiley 2025-08-01
Series:Clinical and Translational Science
Online Access:https://doi.org/10.1111/cts.70295
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