Project Optimus – A Reform in the Dose Optimization and Selection in Oncology Drug Development

Project Optimus is an initiative proposed by the US Food and Drug Administration's Oncology Centre of Excellence (OCE) to provide new guidance for dose optimization early in oncology drug development.

In this white paper, Dr Laurie Smaldone Alsup, SVP Regulatory Science at NDA, explores the goals of Project Optimus and how it can impact time to approval, ultimately aiming to improve the oncology drug development process, and ensure optimal dose selection before approval.

 

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