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A theoretical framework for estimation of AUCs in complete and incomplete sampling designs.

Research output: Contribution to journalJournal article

Published

Journal publication date05/2009
JournalStatistics in Biopharmaceutical Research
Journal number2
Volume1
Number of pages9
Pages176-184
Original languageEnglish

Abstract

Nonclinical in vivo animal studies have to be completed before starting clinical studies of the pharmacokinetic behavior of a drug in humans. The drug exposure in animal studies is often measured by the area under the concentration versus time curve (AUC). The classic complete data design, where each animal is sampled for analysis once per time point, is usually only applicable for large animals. In the case of rats and mice, where blood sampling is restricted, the batch design or the serial sampling design needs to be considered. In batch designs samples are taken more than once from each animal, but not at all time points. In serial sampling designs only one sample is taken from each animal. In this paper we present an estimator for the AUC from 0 to the last time point that is applicable to all three designs. The variance and asymptotic distribution of the estimator are derived and confidence intervals based upon the asymptotic results are discussed and evaluated in a simulation study. Further, we define an estimator for linear combinations of AUCs and investigate its asymptotic properties mathematically as well as in simulation.

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