Analysis of Stability Data
Next Date
Thu/Fri, 3-4/12/2026
Participants
3 - 12
Duration
2 Days
Course Form
online, classroom in Basel or in-house ℹ
Course Description
Are you in charge of assuring that your pharmaceutical, biotechnological, cosmetic, or food product remains stable during a certain period? This course covers the most common methods for the analysis of your stability data and the reliable estimation of the product shelf life. It is aimed at scientists who work in development and quality assurance and who already have basic statistical knowledge (as provided in “Visualization of Lab Data with Excel”).
What Are You Going to Learn?
The course emphasizes graphical methods and the selection of appropriate statistical models. Methods are explained through practical examples and exercises from the chemical, pharmaceutical, and cosmetic industries, using Excel supplemented with the validated EasyStat macros. The requirements of the ICH guidelines are also covered 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 provided in “Visualization of Lab Data with Excel”).
Course Fees
- CHF 795.- per day + 8.1% VAT (incl. course documents and individual participant coaching during the practical exercises) for online courses
- CHF 865.- per day + 8.1% VAT (incl. course documents, individual participant coaching during the practical exercises, break refreshments and lunch) for classroom courses.
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: Basics
Linear regression: parameter estimation and confidence regions
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
Questions about Data Analysis or EasyStat?
We are always at your disposal if you have any questions. Simply call us on +41 61 686 98 77 or use the Contact Form.