Stability Analysis with Statistica (STS)

Target:
The aim of this product course is to familiarize students with the tools of the Statistica data analysis package that are required to determine the runtime of a product or the repeat testing period of an active ingredient. The participants should get an overview of the corresponding procedures in the Higher Models module and control the result output with the corresponding dialog interfaces.

Target group:
This course is aimed at specialists in the laboratory or quality managers in pharmaceutical companies who­wish to perform their stability tests with the Statistica software in accordance with a guideline issued by the International Conference on Harmonisation (ICH).

Course contents:
This course explains how to calculate the runtime or repeat test period and the test sequence for a joint calculation for several batches (poolability) using statistics. The topics:

• Determination of the time function with regression analysis
• Determination of the running time with confidence intervals
• Runtime calculation with SVB macro
• Graphics for batch comparison
• General Linear Models (ALM)
• Covariance Analysis and Test Sequence in ALM
• Stability analysis for several factors

The training consists of a short explanation of the mentioned procedures and the independent training of the course participants in the context of exercises. Generally understandable data sets from published stability studies serve as examples.

Prerequisites:
This course requires program knowledge from "Statistica Introduction" (STE). In order to fully benefit from the training, participants should have statistical knowledge in stability analysis.

Supplementary courses:
For participants without sufficient previous knowledge we offer our method course "Stability Testing and Statistics" (STB).

Duration: 1 day         Time: 9:30 - 17:00 hrs

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