From Plan to Pivot: How Model‐Informed Drug Development Shaped the Dose Strategy of the Zibotentan/Dapagliflozin ZENITH Trials
Anne‐Kristina Mercier,
Sebastian Ueckert,
Mikael Sunnåker
et al.
Abstract:Getting the dose right is a key challenge in drug development; model‐informed drug development (MIDD) provides powerful tools to shape dose strategies and inform decision making. In this tutorial, the case study of the ZENITH trials showcases how a set of clinical pharmacology and MIDD approaches informed an impactful dose strategy. The endothelin A receptor antagonist zibotentan, combined with the sodium‐glucose co‐transporter‐2 inhibitor dapagliflozin, has yielded a robust and significant albuminuria reducti… Show more
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