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

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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Bibliographic Details
Main Authors: Sandrine Micallef, Alexandre Sostelly, Jiawen Zhu, Paul G. Baverel, Francois Mercier
Format: Article
Language:English
Published: Elsevier 2022-04-01
Series:Contemporary Clinical Trials Communications
Subjects:
Adaptive designs
Escalation with overdose control (EWOC)
Bayesian inferences
Population pharmacokinetic modeling
Exposure
Online Access:http://www.sciencedirect.com/science/article/pii/S2451865422000187

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http://www.sciencedirect.com/science/article/pii/S2451865422000187

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