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Which experimental design for phase I clinical trials? Proposal for an investigational approach
I Durieu1, P Girard, J P Boissel
1Unité de Pharmacologie Clinique, Hôpital Neuro-Cardiologique, Lyon, France.
Fundamental & Clinical Pharmacology
|January 1, 1990
Abstract:
The choice of a protocol for the first administration to man of a new drug remains an unresolved problem for the researcher. There are few studies concerning dose-ranging experiments in phase I to determine the threshold and plateau doses of a new drug in a population. A simulation approach may help in evaluating different protocols, by considering how they could be optimized, and by selecting the best protocol for a given case.