The Shifting Paradigm of Dose Selection in Oncology

8 Pages

This insight brief discusses the shift from maximum tolerated dose approaches to patient-centered dose optimization in oncology drug development. It highlights FDA Project Optimus and the need for earlier dose exploration using pharmacokinetics, modeling, and patient-reported outcomes. The paper explains how optimized dosing can improve efficacy, reduce toxicity, and increase regulatory confidence, ultimately leading to better patient outcomes and more efficient development.

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The Shifting Paradigm of Dose Selection in Oncology

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