title: A safety grading scale to support dose escalation and define stopping rules for healthy subject first-entry-into-man studies: some points to consider from the French Club Phase I working group.
authors.affiliation: Association de Recherche Thérapeutique, Centre Hospitalier Lyon Sud, 69495 Pierre-Bénite Cedex Biotrial, 35000 Rennes Cedex, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Sibille
authors.forename: Alain
authors.initials: A
authors.lastname: Patat
authors.forename: Henri
authors.initials: H
authors.lastname: Caplain
authors.forename: Yves
authors.initials: Y
authors.lastname: Donazzolo
mesh_terms: D017321:Clinical Trials, Phase I as Topic / Q000009:adverse effects*; D004305:Dose-Response Relationship, Drug; D015507:Drugs, Investigational / Q000008:administration & dosage* / Q000009:adverse effects*; D006801:Humans
chemical_list: D015507:Drugs, Investigational