A flexible class of models for data arising from a ‘thorough QT/QTc study’
Article first published online: 22 MAR 2010
Copyright © 2010 John Wiley & Sons, Ltd.
Volume 10, Issue 2, pages 122–127, March/April 2011
How to Cite
Anand, S. P. and Ghosh, S. K. (2011), A flexible class of models for data arising from a ‘thorough QT/QTc study’. Pharmaceut. Statist., 10: 122–127. doi: 10.1002/pst.420
- Issue published online: 22 MAR 2010
- Article first published online: 22 MAR 2010
- Bayesian model selection;
- ICH E14;
- thorough QT/QTc study
The standard methods for analyzing data arising from a ‘thorough QT/QTc study’ are based on multivariate normal models with common variance structure for both drug and placebo. Such modeling assumptions may be violated and when the sample sizes are small, the statistical inference can be sensitive to such stringent assumptions. This article proposes a flexible class of parametric models to address the above-mentioned limitations of the currently used models. A Bayesian methodology is used for data analysis and models are compared using the deviance information criteria. Superior performance of the proposed models over the current models is illustrated through a real dataset obtained from a GlaxoSmithKline (GSK) conducted ‘thorough QT/QTc study’. Copyright © 2010 John Wiley & Sons, Ltd.