Outlier detection in bioavailability/bioequivalence studies.

Published

Journal Article

This paper concerns techniques for detection of a potential outlier or extreme observation in a bioavailability/bioequivalence study. A bioavailability analysis that includes possible outlying values may affect the decision on bioequivalence. We consider a general crossover model that takes into account period and formulation effects. We derive two test procedures, the likelihood distance and the estimates distance, to detect potential outliers. We show that the two procedures relate to a chi-square distribution with three degrees of freedom. The main purpose of this paper is to exhibit and discuss these two general approaches of outliers detection in the context of a bioavailability/bioequivalence study. To illustrate these approaches, we use data from three-way crossover experiment in the pharmaceutical industry that concerned the comparison of the bioavailability of two test formulations and a standard (reference) formulation of a drug. This example demonstrates the influence of an outlying value in the study of bioequivalence.

Full Text

Duke Authors

Cited Authors

  • Chow, SC; Tse, SK

Published Date

  • May 1990

Published In

Volume / Issue

  • 9 / 5

Start / End Page

  • 549 - 558

PubMed ID

  • 2135947

Pubmed Central ID

  • 2135947

International Standard Serial Number (ISSN)

  • 0277-6715

Language

  • eng

Conference Location

  • England