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.
Sibille
Michel
M
Association de Recherche Thérapeutique, Centre Hospitalier Lyon Sud, 69495 Pierre-Bénite Cedex Biotrial, 35000 Rennes Cedex, France.
Patat
Alain
A
Caplain
Henri
H
Donazzolo
Yves
Y
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
D015507:Drugs, Investigational