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

Jaki, Thomas and Wolfsegger, Martin J. and Ploner, Meinhard (2009) Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods. Pharmaceutical Statistics, 8 (1). pp. 12-24. ISSN 1539-1604

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    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.

    Item Type: Article
    Journal or Publication Title: Pharmaceutical Statistics
    Additional Information: This is a pre-print of an article accepted for publication in Pharmaceutical Statistics Copyright 2008 Wiley.
    Uncontrolled Keywords: AUC ; bioequivalence ; bootstrap ; serial sampling design ; serial sacrifice design ; sparse sampling
    Subjects: Q Science > QA Mathematics
    Departments: Faculty of Science and Technology > Mathematics and Statistics
    ID Code: 4494
    Deposited By: Dr Thomas Jaki
    Deposited On: 20 Mar 2008 08:47
    Refereed?: Yes
    Published?: Published
    Last Modified: 09 Oct 2013 14:50
    Identification Number:
    URI: http://eprints.lancs.ac.uk/id/eprint/4494

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