Statistical Analysis of Bioavailability Studies: Parametric and Nonparametric Confidence Intervals

Author(s): Diletti, E.

Journal/Book: European Journal of Clinical Pharmacology. 1983; 24: 127-136.

Abstract: For a two-way cross-over design, which appears to be the most common experimental design in bioavailability studies, 95%-confidence limits for expected bioavailability can be obtained by classical analysis of variance (ANOVA). If symmetry of the confidence interval is desired about zero (differences) or unity (ratios) rather than about the corresponding point estimator, Westlake's modification can be used. Two nonparametric methods and their adaptations to bioavailability ratios are reviewed, one based an Wilcoxon's signed rank test (Tukey), and the other an Pitman's permutation test. The necessary assumptions and the merits of these procedures are discussed. The methods are illustrated by an example of a comparative bioavailability study. A FORTRAN program facilitating the procedures is available from the authors upon request.

Keyword(s): statistical analysis

Zurück | Weiter