Which experimental design for phase I clinical trials? Proposal for an investigational approach.
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.
Durieu
I
I
Unité de Pharmacologie Clinique, Hôpital Neuro-Cardiologique, Lyon, France.
Girard
P
P
Boissel
J P
JP
D004341:Drug Evaluation; D006801:Humans; D012107:Research Design