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