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Model-Informed Drug Development for Daprodustat Supports the Design of Individualized Dosing Regimens in Chronic Kidney Disease Patients With Anemia
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DOI：10.1002/cpt.70094.png)
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Abstract
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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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