The assessment of individual and population bioequivalence

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Abstract

We develop a statistical methodology for the assessment of individual bioequivalence when a crossover design is invoked. The location parameters for our model consist of population-averaged parameters for formulation, population-averaged parameters for nuisance effects (sequence, period, carryover, etc.), and subject-specific parameters for formulation. We do not impose any distributional assumptions other than the existence of first- and second-order moments. We derive unbiased estimators for all of the parameters in the model and construct subject-specific bioequivalence scores which exclude the effects of the nuisance parameters. We assess individual bioequivalence by constructing distribution-free tolerance intervals based on the sample of bioequivalence scores.

Original languageEnglish (US)
Pages (from-to)1-14
Number of pages14
JournalJournal of Biopharmaceutical Statistics
Volume6
Issue number1
DOIs
StatePublished - Jan 1 1996

All Science Journal Classification (ASJC) codes

  • Statistics and Probability
  • Pharmacology
  • Pharmacology (medical)

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