Project optimus, an fda initiative: considerations for cancer drug development internationally, from an academic perspective

HIGHLIGHTS

• who: Ravindhi Murphy from the AstraZeneca, United Kingdom Experimental Cancer Medicine Centre, University of Edinburgh, Edinburgh, United Kingdom have published the article: Project Optimus, an FDA initiative: Considerations for cancer drug development internationally, from an academic perspective, in the Journal: (JOURNAL)
• what: In the the authors the FDA`s Oncology Centre of Excellence is addressing this via the Project Optimus initiative: aiming to reform dose optimisation studies so that they can demonstrate the most appropriate dose selection.

SUMMARY

Historically, the MTD has often been synonymous with the recommended phase 2 dose . . .

 



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