12,000

We have over 12,000 students, from over 100 countries, within one of the safest campuses in the UK

93%

93% of Lancaster students go into work or further study within six months of graduating

Home > Research > Publications & Outputs > Establishing bioequivalence in complete and inc...
View graph of relations

« Back

Establishing bioequivalence in complete and incomplete data designs using AUCs.

Research output: Contribution to journalJournal article

Published

Journal publication date07/2010
JournalJournal of Biopharmaceutical Statistics
Journal number4
Volume20
Number of pages18
Pages803-820
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 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.

Bibliographic note

The final, definitive version of this article has been published in the Journal, Journal of Biopharmaceutical Statistics, 20 (4), 2010, © Informa Plc

Related research outputs