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Outlier detection in bioavailability/bioequivalence studies.

Publication ,  Journal Article
Chow, SC; Tse, SK
Published in: Stat Med
May 1990

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.

Duke Scholars

Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

May 1990

Volume

9

Issue

5

Start / End Page

549 / 558

Location

England

Related Subject Headings

  • Statistics & Probability
  • Reference Standards
  • Pharmacokinetics
  • Models, Statistical
  • Linear Models
  • Likelihood Functions
  • Humans
  • Drug Evaluation
  • Chi-Square Distribution
  • Chemistry, Pharmaceutical
 

Citation

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Chow, S. C., & Tse, S. K. (1990). Outlier detection in bioavailability/bioequivalence studies. Stat Med, 9(5), 549–558. https://doi.org/10.1002/sim.4780090508
Chow, S. C., and S. K. Tse. “Outlier detection in bioavailability/bioequivalence studies.Stat Med 9, no. 5 (May 1990): 549–58. https://doi.org/10.1002/sim.4780090508.
Chow SC, Tse SK. Outlier detection in bioavailability/bioequivalence studies. Stat Med. 1990 May;9(5):549–58.
Chow, S. C., and S. K. Tse. “Outlier detection in bioavailability/bioequivalence studies.Stat Med, vol. 9, no. 5, May 1990, pp. 549–58. Pubmed, doi:10.1002/sim.4780090508.
Chow SC, Tse SK. Outlier detection in bioavailability/bioequivalence studies. Stat Med. 1990 May;9(5):549–558.
Journal cover image

Published In

Stat Med

DOI

ISSN

0277-6715

Publication Date

May 1990

Volume

9

Issue

5

Start / End Page

549 / 558

Location

England

Related Subject Headings

  • Statistics & Probability
  • Reference Standards
  • Pharmacokinetics
  • Models, Statistical
  • Linear Models
  • Likelihood Functions
  • Humans
  • Drug Evaluation
  • Chi-Square Distribution
  • Chemistry, Pharmaceutical