R102 :: Design & Analysis for Stability Studies :: 1 day

Stability studies are used to establish the shelf life of products. This workshop helps you with the practical application of  the appropraite Design of Experiments (DoE) principles, creating the potential to dramatically reduce the high level of resources traditionally committed to this activity. The workshop refers to the regulatory guidelines (ICH guidelines) for conducting stability studies. You’ll get hands-on experience (via an easy-to-use Excel add-in, CELLULA-S) of applying the statistical techniques used to design, analyse and report these studies, and of managing and interpreting the associated scientific data.

Topics Covered

• Designing standard Stability Studies
• Linear Regression, Analysis of Variance and Analysis of Covariance
• Deriving Shelf Life Estimate(s) depending on the extent to which results may be pooled
• Apply Bracketing by testing only extreme concentrations
• Apply Matrixing to the Full Design to ensure a greater economy of resources

Software Tools Used*

CELLULA-S, Design Expert DX7 hands-on

Each workshop fee includes a 12 month licence to install and run a copy of CELLULA-S (option to renew the software licence in future years at £395 per annum)

Who Should Attend?

All scientists and engineers involved in establishing the shelf-life of products

Recommended Preparation

• No special preparation required

When and Where?                                              hold a place for me  

• 4th Nov 2009 :: £495 :: Cambridge, UK