Short Communication (Pharmacometrics) Sample Size Determination for Bioequivalence Assessment Using a Multiplicative Model

Author(s): Steinijans, V., Diletti, E., Burke, M.

Journal/Book: Journal of Pharmacokinetics and Biopharmaceutics. 1992; 20: 557-561.

Abstract: In bioequiualence studies Cmax and AUC serve as the primary pharmacokinetic characteristics of rate and extent of absorption. Based an pharmacokinetic relationships and an empirical evidence, the distribution of these characteristics corresponds to a multiplicative model, which implies a logarithmic normal distribution in the case of a parametric analysis. Hence, consideration is given to exact and approximate formulas of sample sizes in Lire case of a multiplicative model.

Keyword(s): bioequivalence

Zurück | Weiter