Design and Statistical Analysis of Stability Studies (LY1296)

Venue: The Westin Hotel

Location: Dublin, Ireland

Event Date/Time: Mar 09, 2005 End Date/Time: Mar 09, 2005
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Although the ICH Q1A Stability Testing Guidance has allowed the use of bracketing and matrixing designs since 1998, most pharmaceutical companies still do not use these designs, and use full testing which dramatically increases their costs. This course offers participants the opportunity to do practical hands-on design of studies on some model situations, illustrating how to carry out cost-efficient stability studies for products with many packs, pack sizes, strengths and much more.

The requirements for statistical analysis of stability data have been revised and issued. This course will offer participants an opportunity to carry out statistical analysis of some model data using an Excel stability computer programme and discuss their conclusions.


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