Optimizing the science of drug development: opportunities for better candidate selection and accelerated evaluation in humans.
Two international meetings were convened in 1998 to review the current science of drug development and the potential opportunities to optimize the evaluation of new drugs in humans. This report represents a synopsis of these meetings, and focuses on the current state of knowledge pertaining to drug development, future scientific and technical needs, and the relative merits of various strategies intended to accelerate the clinical development of drugs.
Office of Clinical Pharmacology and Biopharmaceutics, Food and Drug Administration, Rockville, Maryland, USA.
L J
LJ
Lesko
M
M
Rowland
C C
CC
Peck
T F
TF
Blaschke
D000818:Animals; D002626:Chemistry, Pharmaceutical; D002986:Clinical Trials as Topic; D003198:Computer Simulation; D006801:Humans; D010599:Pharmacokinetics; D012107:Research Design