Bioanalytical method validation--a revisit with a decade of progress.
Shah
V P
VP
Food and Drug Administration, Center for Drug Evaluation and Research, Rockville, MD 20857, USA.
Midha
K K
KK
Findlay
J W
JW
Hill
H M
HM
Hulse
J D
JD
McGilveray
I J
IJ
McKay
G
G
Miller
K J
KJ
Patnaik
R N
RN
Powell
M L
ML
Tonelli
A
A
Viswanathan
C T
CT
Yacobi
A
A
D001681:Biological Assay; D001682:Biological Availability; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations / Q000032:analysis*; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency
D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations