21 Citations (Scopus)

Abstract

We propose an approach for comparing directly the reference and test blood concentration x time profiles of subjects in a bioequivalence trial under a crossover design. We compare the test and reference profiles via the construction of two regions, namely, an acceptable region based on the reference profile and another region based on reflecting the test profile about the reference profile. Also, we describe how to construct these regions if the assay for measuring the concentration has a lower limit of detection and how to adjust the reference and test concentrations of the subjects participating in a bioequivalence trial. If the test and reference formulations are bioequivalent, then the area displaced by the latter region should be less than the area displaced by the acceptable region. Therefore, we construct a ratio of these areas for each subject. Then we calculate upper confidence limits for quantiles, either under the assumption of lognormality or based on a bootstrapping algorithm, to investigate population and/or individual bioequivalence.

Original languageEnglish (US)
Pages (from-to)113-123
Number of pages11
JournalJournal of Biopharmaceutical Statistics
Volume7
Issue number1
DOIs
StatePublished - Jan 1 1997

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Bioequivalence
Therapeutic Equivalency
Hematologic Tests
Cross-Over Studies
Limit of Detection
Crossover Design
Confidence Limits
Bootstrapping
Quantile
Population
Blood
Profile
Calculate
Formulation

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

Cite this

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The multivariate assessment of bioequivalence. / Chinchilli, V. M.; Elswick, Jr.

In: Journal of Biopharmaceutical Statistics, Vol. 7, No. 1, 01.01.1997, p. 113-123.

Research output: Contribution to journalArticle

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