Regulatory Requirements training

Design & Analysis for Stability Studies
R102 - 1 day

Stability studies are used to establish the shelf life of products. This workshop helps you with the practical application of  the appropriate 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 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

We can deliver this course using a flexible choice of software packages; please just contact us to discuss using your current in-house tool.

Who should attend?

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

Recommended Preparation

No special preparation required

Please also see the following workshops:

There are no public workshops currently scheduled for this course - please contact us to learn when we'll next be running it.