[Proof of bioequivalence of two nifedipine preparations].
A crossover-study was performed with 20 volunteers in order to demonstrate the bioequivalence of two nifedipine preparations after single dose application. Methods for demonstrating bioequivalence were according to the APV (Arbeitsgemeinschaft für pharmazeutische Verfahrenstechnik)- and FDA-guidelines; in addition some new but less well-known biometric procedures were used. Bioequivalence could be proved for the criteria AUC, Cmax and tmax as stated in the nifedipine monograph of Zentrallaboratorium Deutscher Apotheker.
Herrmann
R
R
Abteilung Analytische Entwicklung der Fa. Dr. Rentschler Arzneimittel GmbH & Co., München.
Rahlfs
V W
VW
Zimmermann
H
H
D000328:Adult; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D008297:Male; D009543:Nifedipine / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
D009543:Nifedipine
Zum Nachweis der Bioäquivalenz von zwei Nifedipin-Präparaten.