Research output: Contribution to Journal/Magazine › Journal article › peer-review
Research output: Contribution to Journal/Magazine › Journal article › peer-review
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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 -