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

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Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods. / Jaki, Thomas; Wolfsegger, Martin J.; Ploner, Meinhard.
In: Pharmaceutical Statistics, Vol. 8, No. 1, 01.2009, p. 12-24.

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Jaki T, Wolfsegger MJ, Ploner M. Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods. Pharmaceutical Statistics. 2009 Jan;8(1):12-24. doi: 10.1002/pst.321

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Jaki, Thomas ; Wolfsegger, Martin J. ; Ploner, Meinhard. / Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods. In: Pharmaceutical Statistics. 2009 ; Vol. 8, No. 1. pp. 12-24.

Bibtex

@article{7e50b1478f5d46fab58ec9d0baa0fd24,
title = "Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods.",
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.",
keywords = "AUC, bioequivalence, bootstrap, serial sampling design, serial sacrifice design, sparse sampling",
author = "Thomas Jaki and Wolfsegger, {Martin J.} and Meinhard Ploner",
note = "This is a pre-print of an article accepted for publication in Pharmaceutical Statistics Copyright 2008 Wiley.",
year = "2009",
month = jan,
doi = "10.1002/pst.321",
language = "English",
volume = "8",
pages = "12--24",
journal = "Pharmaceutical Statistics",
issn = "1539-1604",
publisher = "John Wiley and Sons Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Confidence Intervals for Ratios of AUC's in the Case of Serial Sampling : A Comparison of Seven Methods.

AU - Jaki, Thomas

AU - Wolfsegger, Martin J.

AU - Ploner, Meinhard

N1 - This is a pre-print of an article accepted for publication in Pharmaceutical Statistics Copyright 2008 Wiley.

PY - 2009/1

Y1 - 2009/1

N2 - 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.

AB - 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.

KW - AUC

KW - bioequivalence

KW - bootstrap

KW - serial sampling design

KW - serial sacrifice design

KW - sparse sampling

U2 - 10.1002/pst.321

DO - 10.1002/pst.321

M3 - Journal article

VL - 8

SP - 12

EP - 24

JO - Pharmaceutical Statistics

JF - Pharmaceutical Statistics

SN - 1539-1604

IS - 1

ER -