Establishing bioequivalence in complete and incomplete data designs using AUCs.

Jaki, Thomas and Wolfsegger, Martin J. and Lawo, John-Philip (2010) Establishing bioequivalence in complete and incomplete data designs using AUCs. Journal of Biopharmaceutical Statistics, 20 (4). pp. 803-820. ISSN 1054-3406

Full text not available from this repository.


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 classical complete data design where each animal is sampled for analysis at every time point is applicable for large animals only. In the case of small animals, where blood sampling is restricted, the batch design or the serial sampling design need 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 article we derive the asymptotic distribution for the ratio of two AUCs and construct different confidence intervals, which are frequently used to assess bioequivalence. The performance of these intervals is then evaluated between the different designs in a simulation study. Additionally, the sample sizes required for the different designs are compared.

Item Type:
Journal Article
Journal or Publication Title:
Journal of Biopharmaceutical Statistics
Additional Information:
The final, definitive version of this article has been published in the Journal, Journal of Biopharmaceutical Statistics, 20 (4), 2010, © Informa Plc
Uncontrolled Keywords:
ID Code:
Deposited By:
Deposited On:
26 Aug 2008 08:01
Last Modified:
21 Nov 2022 18:07