Sponsors should ensure dose optimisation is a part of early trial planning for oncology trials as the US Food and Drug Administration (FDA) continues to modernise dosing via Project Optimus. "My ...
HANOVER, MD, May 18, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (PCSA) (“Processa” or the “Company”) today announces it has received guidance from the U.S. Food and Drug Administration ...
In this JCO Article Insights episode, Subodh Selukar interviews author Dr. Robert Maki on "Combining Response and Toxicity Data to Implement Project Optimus" by Maki, et al published in the Journal of ...
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