is being presented by Steven Walfish, President, of Statistical Outsourcing Services and airs on Wednesday, July 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
The ICH Q1 is not prescriptive on which statistics are most appropriate for reporting stability data. More importantly, using the incorrect statistics can lead to incorrect conclusions.
In this audio conference, our speaker reviews the statistical concepts used in stability analysis, using an overview of the ICH Q1 guidance as the framework for discussion. The presentation looks at linear models as the statistical tool used for stability analysis, but also covers methods for dealing with data that does fit the linear model. Typically, regression analysis is used to assess stability, and in this audio conference the speaker highlights the assumptions and risks of regression. Finally, the presentation draws on real-life examples to discuss the covariance model for determining poolability of the lots.
