Where are we now and where do we go next in terms of the scientific basis for regulation on bioavailability and bioequivalence? FDA Biopharmaceutics Coordinating Committee.
Williams
R L
RL
Office of Pharmaceutical Science, Center for Drug Evaluation and Research, US Food and Drug Administration, Rockville, Maryland, USA.
Adams
W
W
Chen
M L
ML
Hare
D
D
Hussain
A
A
Lesko
L
L
Patnaik
R
R
Shah
V
V
D001682:Biological Availability; D004282:Documentation / Q000379:methods / Q000592:standards; D004345:Drug Industry; D005544:Forecasting; D006801:Humans; D010599:Pharmacokinetics; D013810:Therapeutic Equivalency