Clinical pharmacology and first-time-in-man studies: the FDA levels the playing field.
Luderer
J
J
Piergies
A A
AA
Jorkasky
D
D
Sedman
A
A
Reele
S
S
Froehlich
J
J
Cavanaugh
J
J
Steinman
G L
GL
D017321:Clinical Trials, Phase I as Topic; D015507:Drugs, Investigational / Q000592:standards* / Q000627:therapeutic use; D005060:Europe; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration
D015507:Drugs, Investigational