ReviewClinical pharmacology and therapeutics2026
Model-Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia.
Review in Clinical pharmacology and therapeutics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors.
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Abstract
Model-informed drug development (MIDD) played a crucial role in the successful development and regulatory approval of daprodustat, a novel oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor aimed at treating anemia in chronic kidney disease patients. MIDD was pivotal in optimizing dosing strategies and enabling effective dose individualization, ensuring the right dose for the right patient. This tutorial illustrates how integrated quantitative approaches, including longitudinal hemoglobin response modeling, population pharmacokinetics (PopPK), and clinical trial simulations, were applied to guide phase III dose selection, inform trial design, and support regulatory interactions. We highlight the evolution and application of these models, emphasizing key development decisions, challenges encountered, and insights gained.
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