[First-in-human clinical trials: comparison of EMEA and FDA guidelines].
Hernández-López
Cándido
C
Farmacología Clínica, Departamento Médico/I+D, Laboratorios Rubió, Castellbisbal, Barcelona, España. c.hernandez@laboratoriosrubio.com
D002986:Clinical Trials as Topic / Q000592:standards*; D005060:Europe; D006077:Government Agencies; D006801:Humans; D017410:Practice Guidelines as Topic; D014481:United States; D014486:United States Food and Drug Administration