Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans.
Choudary
J
J
U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD 20857, USA.
Contrera
J F
JF
DeFelice
A
A
DeGeorge
J J
JJ
Farrelly
J G
JG
Fitzgerald
G
G
Goheer
M A
MA
Jacobs
A
A
Jordan
A
A
Meyers
L
L
Osterberg
R
R
Resnick
C
C
Sun
C J
CJ
Temple
R J
RJ
D000818:Animals; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D008297:Male; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D010600:Pharmacology; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D004364:Pharmaceutical Preparations