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(Online) Courses

Analysis of Stability Data

Thu/Fri, 10-11/12/2020

The course covers those statistical methods that are needed for the analysis of stability data.

What will you learn ?
Are you in charge of making sure that your pharmaceutical, biotechnological, cosmetic or food product keeps constant properties during a fixed period of time? In this course, you will learn the most common methods for the state-of-the-art analysis of your product stability data and the reliable estimation of its shelf life. The emphasis is on the use of graphical methods and the choice and fit of appropriate statistical models. The methods will be explained using many practical examples and exercises that stem from the chemical, pharmaceutical and cosmetic industries; for this purpose, the software Excel is used and completed by validated macros (EasyStat). The requirements of the ICH guidelines will also be presented in detail.

Who should attend ?
  • Quality managers, chemists, pharmacists and engineers who are responsible for the stability or the quality of products during a fixed period of time
  • Elementary statistical knowledge is assumed (as given in the course "Visualization of Lab Data" )

Which topics are covered ?
 Basic Concepts
 Data Situation
Requirements of the ICH guidelines for the execution
and evaluation of stability studies
Statistical basics
 Analysis of stability data (basic topics)
 Linear regression:
  • Parameter estimation
  • Confidence domains
Prediction of the stability
Prediction of the shelf life
  Analysis of stability data (advanced topics)
 Covariance analysis
Batch pooling
Consideration of additional factors (e.g. packaging)
Bracketing and Matrixing
Treatment of several responses

Any questions ?
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