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Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods.

Research output: Contribution to journalJournal article

Published

Journal publication date01/2009
JournalPharmaceutical Statistics
Journal number1
Volume8
Number of pages13
Pages12-24
Original languageEnglish

Abstract

Pharmacokinetic studies are commonly performed using the two-stage approach. The first stage involves estimation of pharmacokinetic parameters like the area under the concentration versus time curve (AUC) for each analysis subject separately and the second stage uses the individual parameter estimates for statistical inference. This two-stage approach is not applicable in sparse sampling situations where only one sample is available per analysis subject like in non-clinical in-vivo studies. In a serial sampling design only one sample is taken from each analysis subject. A simulation study was carried out to assess coverage, power and type I error of seven methods to construct two-sided 90% confidence intervals for ratios of two AUC's assessed in a serial sampling design, which can be used to assess bioequivalence in this parameter.

Bibliographic note

This is a pre-print of an article accepted for publication in Pharmaceutical Statistics Copyright 2008 Wiley.