Stability Testing and Statistics (STB)
Training course objectives
The aim of this method course is to present statistical methods for determining the running time of a product or the repeat test period of an active substance during long-term storage. The guideline Q1E of the International Conference on Harmonization (ICH) contains concrete guidelines for the statistical processing of stability data, the understanding of which will be facilitated in this seminar.
Target group
This course addresses specialists in the laboratory or quality managers in pharmaceutical companies who want to perform stability tests using statistical methods.
Course contents
This course introduces the statistical procedures of the Q1E Directive for determining the life of a product. The test sequence for poolability in stability analysis is explained. The understanding of the test sequence is facilitated by flow charts.
The subjects
- Requirements of the ICH for the analysis of stability data
- Determination of the time function with regression analysis
- Determination of the running time with confidence estimate
- Treatment of several batches according to the Q1E directive
- Covariance analysis and test sequence (poolability)
- Stability analysis for several factors
The training consists of a detailed explanation of the mentioned procedures with generally understandable data examples from published stability studies.
Requirements
Neither Statistica's knowledge of statistics nor its programme is required in this seminar. In order to fully benefit from the training, participants should be somewhat familiar with the basic concepts of stability testing.
Supplementary courses:
Method courses
product courses
- "Statistica Introduction" (STE)
- "Stability Analysis with Statistica" (STS) - request individual training
Duration: 1 day Time: 9:30 - 17:00 h Price: EUR 800,- (plus VAT) per participant
Testing
Contact
Search