The impact of outlying subjects on decision of bioequivalence.

Journal Article (Journal Article)

As a consequence of a hearing on bioequivalence conducted by the Food and Drug Administration in 1986, the identification and the treatment of a potential outlier in bioequivalence trials has become an important issue in the assessment of bioequivalence because the exclusion of a statistically identified outlier may lead to a totally different conclusion on bioequivalence. In this paper, we examine the impact of a statistically identified outlying subject on the decision of bioequivalence through a simulation study under the structure of a standard two-way crossover design based on interval hypotheses for bioequivalence. The Hotelling T2 test suggested by Liu and Weng (1) is used for detection of an outlying subject.

Full Text

Duke Authors

Cited Authors

  • Ki, FY; Liu, JP; Wang, W; Chow, SC

Published Date

  • March 1995

Published In

Volume / Issue

  • 5 / 1

Start / End Page

  • 71 - 94

PubMed ID

  • 7613561

International Standard Serial Number (ISSN)

  • 1054-3406

Digital Object Identifier (DOI)

  • 10.1080/10543409508835099


  • eng

Conference Location

  • England