Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?

Autor: Timothy Qi, Tyler Dunlap, Yanguang Cao
Rok vydání: 2022
Předmět:
Zdroj: Pharm Res
ISSN: 1573-904X
0724-8741
DOI: 10.1007/s11095-022-03380-1
Popis: Project Optimus is a US Food and Drug Administration (FDA) initiative to reform dose selection in oncology drug development. Here, we focus on tumor evolution, a broadly observed phenomenon that invariably leads to therapeutic failure and disease relapse, and its effect on the exposure-response (E-R) relationships of oncology drugs. We propose a greater emphasis on tumor evolution during clinical development to facilitate the selection of optimal doses for molecularly targeted therapies and immunotherapies in oncology.
Databáze: OpenAIRE
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