Moving Beyond Boundaries: Utilization of Longitudinal Exposure–Response Model for Bounded Outcome Score to Inform Decision Making in the Accelerated Drug Development Paradigm

    February 2024 in “ Clinical Pharmacokinetics ”
    Yeamin Huh, Jessica Wojciechowski, Vivek S. Purohit
    Studysummary This study found that modeling and simulation effectively informed decision-making and dose selection for ritlecitinib in treating alopecia areata, supporting an accelerated drug development strategy.
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    Research cited in this study 5

    1. Evolution of Ritlecitinib Population Pharmacokinetic Models During Clinical Drug Development Clinical Pharmacokinetics · 2023
    2. A Phase 2a Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of the Oral Janus Kinase Inhibitors Ritlecitinib and Brepocitinib in Alopecia Areata: 24-Week Results Journal of the American Academy of Dermatology · 2021
    3. Tofacitinib for the Treatment of Severe Alopecia Areata and Variants: A Study of 90 Patients Journal of The American Academy of Dermatology · 2016
    4. Alopecia Areata Profiling Shows TH1, TH2, and IL-23 Cytokine Activation Without Parallel TH17/TH22 Skewing ˆThe ‰journal of allergy and clinical immunology/Journal of allergy and clinical immunology/˜The œjournal of allergy and clinical immunology · 2015
    5. Investigative Guidelines for Alopecia Areata Dermatologic therapy · 2011