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The Statistics of Phase 0 Trials

The PD-driven phase 0 trial is a new form, designed to be a first-in-man study, often of a new agent, conducted to assess drug effect on a molecular target, by means of a pharmacodynamic (PD) assay, in a very small number (10–15) of patients. Such a study is meant to be a proof of principle trial to...

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Bibliografiske detaljer
Main Authors: Rubinstein, Larry V., Steinberg, Seth M., Kummar, Shivaani, Kinders, Robert, Parchment, Ralph E., Murgo, Anthony J., Tomaszewski, Joseph E., Doroshow, James H.
Format: Artigo
Sprog:Inglês
Udgivet: 2010
Fag:
Online adgang:https://ncbi.nlm.nih.gov/pmc/articles/PMC3902019/
https://ncbi.nlm.nih.gov/pubmed/20419759
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/sim.3840
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