Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
Pharm Res
; 39(12): 3259-3265, 2022 Dec.
Article
em En
| MEDLINE
| ID: mdl-36056271
ABSTRACT
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.
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Texto completo:
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Base de dados:
MEDLINE
Assunto principal:
Neoplasias
/
Antineoplásicos
Limite:
Humans
País como assunto:
America do norte
Idioma:
En
Ano de publicação:
2022
Tipo de documento:
Article