ReviewClinical and translational science2025
Model-Informed Paradigm in Drug Development-An End-To-End Case Study From Upadacitinib Development.
Review in Clinical and translational science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Development Trends of Janus Kinase Inhibitors (JAKi) Over Three Decades: From Common to Rare Diseases.Drug design, development and therapy · 2026Review
- Model-Informed Paradigm in Drug Development-An End-To-End Case Study From Upadacitinib Development.Clinical and translational science · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
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 drug development, the use of tools that improve efficiency, like MIDD, is increasingly crucial. A unique case for the successful application of MIDD approaches from early Phase 1 through postapproval for the upadacitinib development program is described herein. Upadacitinib is an orally administered selective Janus kinase inhibitor, which is approved for rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, axial spondylarthritis, nonradiographic axial spondyloarthritis, ulcerative colitis, and Crohn's disease for adults, in addition to recent approvals for polyarticular juvenile idiopathic arthritis and pediatric patients with psoriatic arthritis. Applications and impact of modeling and simulation approaches for informing key development decisions are presented to highlight the success of using MIDD for the clinical development of upadacitinib. The lessons learned can provide a framework for the clinical development of other drugs.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.