Analysis of Stability Data

Practical exercises will make use of STATISTICA and each participant will receive a free one-month evaluation copy of the software if required. No previous knowledge of the statistical methods is assumed.

* Overview of statistical requirements in ICH guidelines
* Introduction to Linear Regression
* Using linearising transformations
* Estimation of shelf life using confidence/prediction limits
* Single Factor, Multi-Batch Studies
* Introduction to General Linear Models
* Testing for Poolability of batches
* Introduction to Multi-factor Studies (Bracketing & Matrixing Designs)

This one-day course can be delivered on-site for groups of participants and a two-day version can be arranged to include more advanced topics and/or analysis examples using your own study data.