A comparison of four different methods for outlier detection in bioequivalence studies

Timothy Ramsay, Naser Elkum

Research output: Contribution to journalArticle

14 Citations (Scopus)

Abstract

Bioequivatence studies, required by law whenever a new formulation of an existing drug product is introduced to the market, are designed to test whether the bioavailability, defined as the rate and extent to which a substance reaches systemic circulation, is equivalent for each of two or more formulations. Detection and treatment of outlying data in bioequivalence studies are practically important, because inclusion or deletion of potential outlying data may lead to a different conclusion concerning bioequhalence. A review of the literature reveals that four different methods have been proposed for detecting outliers in bioavailability/bioequivalence studies. We present the results of an extensive computer simulation testing the small sample performance of these four testing methods, the results of which indicate that one of these, the estimates distance test, is substantially more powerful than the alternatives.

Original languageEnglish
Pages (from-to)43-52
Number of pages10
JournalJournal of Biopharmaceutical Statistics
Volume15
Issue number1
DOIs
Publication statusPublished - 2005
Externally publishedYes

Fingerprint

Bioequivalence
Therapeutic Equivalency
Outlier Detection
Biological Availability
Drug Compounding
Testing
Formulation
Small Sample
Computer Simulation
Deletion
Outlier
Drugs
Inclusion
Alternatives
Estimate
Market
Review

Keywords

  • Bioavailability
  • Bioequivalence
  • Outlier
  • Outlier detection

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

Cite this

A comparison of four different methods for outlier detection in bioequivalence studies. / Ramsay, Timothy; Elkum, Naser.

In: Journal of Biopharmaceutical Statistics, Vol. 15, No. 1, 2005, p. 43-52.

Research output: Contribution to journalArticle

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