Review of the statistical analysis of the dog telemetry study
Version of Record online: 22 OCT 2010
Copyright © 2010 John Wiley & Sons, Ltd.
Volume 10, Issue 3, pages 236–249, May/June 2011
How to Cite
Aylott, M., Bate, S., Collins, S., Jarvis, P. and Saul, J. (2011), Review of the statistical analysis of the dog telemetry study. Pharmaceut. Statist., 10: 236–249. doi: 10.1002/pst.454
- Issue online: 16 MAY 2011
- Version of Record online: 22 OCT 2010
- QT interval;
In 2008, the PSI Toxicology Special Interest Group met to discuss the design and analysis of dog telemetry studies. The dog telemetry study is one component of the integrated cardiovascular assessment required by regulatory bodies. Although there are guidelines for these studies, little is said about the statistical analysis. With parameters of interest measured continually over time, in studies typically involving four dogs, the analysis is not straightforward. This has led to many different types of analysis being proposed in the literature, with many different methods applied within the pharmaceutical industry itself. This paper summarizes the PSI Toxicology group's discussions and recommendations around these issues. Copyright © 2010 John Wiley & Sons, Ltd.