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The Impact of the FDA's Project Optimus on Oncology Drug Trials
In an interview with Pharmacy Times®, Maria Whitman, Global Head of the Pharmaceutical and Biotech Practice at ZS, discusses the FDA’s Project Optimus, the FDA’s new guidance addressing dose optimization issues in oncology clinical trials, and how it has impacted drug manufacturers.
Pharmacy Times interviewed Maria Whitman, Global Head of the Pharmaceutical and Biotech Practice at ZS, on the FDA's Project Optimus, a recently implemented guidance designed to restructure how oncology drug dosages are chosen.
In this discussion, Whitman explains the impact that the measure has had to date, how clinical trials have adapted to Project Optimus so far, and what responses drug manufactures have had to these guidelines.
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