title: [Proof of bioequivalence of two nifedipine preparations].
abstract: 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.
authors.affiliation: Abteilung Analytische Entwicklung der Fa. Dr. Rentschler Arzneimittel GmbH & Co., München.
authors.forename: R
authors.initials: R
authors.lastname: Herrmann
authors.forename: V W
authors.initials: VW
authors.lastname: Rahlfs
authors.forename: H
authors.initials: H
authors.lastname: Zimmermann
mesh_terms: D000328:Adult; D002851:Chromatography, High Pressure Liquid; D006801:Humans; D008297:Male; D009543:Nifedipine / Q000493:pharmacokinetics*; D013810:Therapeutic Equivalency
chemical_list: D009543:Nifedipine
vernacular_title: Zum Nachweis der Bioäquivalenz von zwei Nifedipin-Präparaten.