Reference tables for the intrasubject coefficient of variation in bioequivalence studies.
Bioequivalence studies are usually performed as crossover studies and, therefore, information on the intrasubject coefficient of variation is needed for sample size planning. However, this information is usually not accessible in publications on bioequivalence studies, and only the pooled inter- and intrasubject coefficient of variation for either test or reference formulation is reported. It is the purpose of the present communication to provide reference values of the intrasubject coefficient of variation for various previously investigated drugs. The presentation includes pertinent pharmacokinetic characteristics for immediate- and extended-release formulations in single- and multiple-dose crossover studies.
Steinijans
V W
VW
Department of Biometry, Byk Gulden Pharmaceuticals, Konstanz, Germany.
Sauter
R
R
Hauschke
D
D
Diletti
E
E
Schall
R
R
Luus
H G
HG
Elze
M
M
Blume
H
H
Hoffmann
C
C
Franke
G
G
D000284:Administration, Oral; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004304:Dosage Forms; D017408:Guidelines as Topic; D006801:Humans; D007275:Injections, Intravenous; D015588:Observer Variation; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D012015:Reference Standards; D012016:Reference Values; D013810:Therapeutic Equivalency
D003692:Delayed-Action Preparations; D004304:Dosage Forms; D004364:Pharmaceutical Preparations