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Amandine Manon, PharmD

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Director, Clinical Pharmacology and Translational Medicine, Certara

Articles by Amandine Manon, PharmD

FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

ByJulie Bullock, PharmD,Krithika Shetty, PhD,Amandine Manon, PharmD,Justin Hay, PhD
April 24th 2023

January 2023 guidance from FDA on dosages in oncology provides further context on expectations with Project Optimus.

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  • FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers
    FDA’s Project Optimus Guidance: Highlights and Tips for Success for Oncology Drug Developers

    Published: April 24th 2023 | Updated:



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