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Strategies for successful dose optimization in oncology drug development: a practical guide

Qiqi Deng1, Lili Zhu1, Brendan Weiss2

  • 1Biostatistics and Programming, Moderna Inc., Cambridge, MA, USA.

Journal of Biopharmaceutical Statistics
|August 11, 2024
PubMed
Summary

New oncology drugs require novel dose optimization strategies beyond traditional maximum tolerated dose (MTD) methods. This study proposes a framework for improved dose selection in early-phase clinical trials for novel cancer therapeutics.

Keywords:
Dose optimizationPK/PDdose findingdose selectiononcologyproject optimusproof of concept

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