Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
Lesko
L J
LJ
Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD 20851, USA.
Rowland
M
M
Peck
C C
CC
Blaschke
T F
TF
Breimer
D
D
de Jong
H J
HJ
Grahnen
A
A
Kuhlmann
J J
JJ
Stewart
B
B
D000818:Animals; D001702:Biopharmaceutics / Q000379:methods; D002626:Chemistry, Pharmaceutical / Q000379:methods; D002986:Clinical Trials as Topic / Q000379:methods; D003198:Computer Simulation; D004353:Drug Evaluation, Preclinical; D006801:Humans; D010601:Pharmacology, Clinical / Q000379:methods