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Bookmark or Share- Project Optimus | FDA - U.S. Food and Drug AdministrationThe Oncology Center of Excellence (OCE) Project Optimus is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development.
- Optimizing the FDA’s Project Optimus: opportunities and ...Through Project Optimus, the FDA calls for radical changes in the design of early phase trials to identify the optimal doses of oncology drugs to achieve maximal efficacy with better tolerability...
- Dosage optimization in drug development: An FDA Project ...Project Optimus is working with stakeholders to advance a DO paradigm that occurs early and throughout premarket development to ensure an optimized recommended dosage at the time of approval.
- The FDA’s Project Optimus targets cancer drug dosages and ...The FDA has begun requiring companies to pinpoint the right dosage before cancer drugs reach patients. When doctors began using the drug sotorasib in 2021 with high expectations for its innovative...
- Oncology Center of Excellence | FDAProject Orbis provides a framework for concurrent submission and review of oncology products among international regulators, which may allow patients with cancer to receive earlier access to...
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