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Exposure driven dose escalation design with overdose control: Concept and first real life experience in an oncology phase I trial

BACKGROUND: Escalation With Overdose Control (EWOC) designs are increasingly used to ensure dose-toxicity curve of investigational oncology drugs is efficiently characterized during dose escalation steps. We propose a novel EWOC-based method that integrates the longitudinal pharmacokinetic (PK) data...

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Detalles Bibliográficos
Autores principales: Micallef, Sandrine, Sostelly, Alexandre, Zhu, Jiawen, Baverel, Paul G., Mercier, Francois
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8851091/
https://www.ncbi.nlm.nih.gov/pubmed/35198796
http://dx.doi.org/10.1016/j.conctc.2022.100901