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...
Main Authors: | Sandrine Micallef, Alexandre Sostelly, Jiawen Zhu, Paul G. Baverel, Francois Mercier |
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Format: | Article |
Language: | English |
Published: |
Elsevier
2022-04-01
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Series: | Contemporary Clinical Trials Communications |
Subjects: | |
Online Access: | http://www.sciencedirect.com/science/article/pii/S2451865422000187 |
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