StatSoft PS Product Stability

The StatSoft PS Product Stability application is used for the statistical evaluation is used for statistical evaluation of accelerated, long-term and on-going stability studies conducted for a medicinal product. The application allows you to determine the shelf life based on long-term and accelerated stability studies and identify atypical trends during ongoing stability studies. The application is validated according to cGxP requirements.

Main functionalities:

Defining the objective, description, and study context
Saving/opening raw data in Excel or Statistica format
Selecting performance characteristics and statistical data analysis methods
Generating reports in Word or PDF format, including English-language options
Saving/opening complete studies along with selected settings
Longterm stability study
- Determination of shelf-life based on confidence interval and/or prediction interval
- Determination of shelf-life based on one-sided or two-sided interval
- Selection of a linear statistical model with and without data transformation
- Evaluation of goodness of fit for all available statistical models
- Analysis of statistical significance of the selected model using t-test and F-test
- Analysis of validity of the selected model using residuals analysis
- Analysis of multiple batches with assessment of data poolability using ANCOVA
- Analysis of predicted values for the selected time interval
- Overall summary of the analysis for all tested batches/parameters
Accelerated stability study
- Estimating shelf life based on the Arrhenius model
- Estimating shelf life based on the Q10 method
Ongoing stability study
- Analysis of the out-of-trend OOT result in relation to historical series using
  By time point control chart
  By time point prediction interval
  By slope control chart
  Random coefficient regression
- Analysis of the out-of-trend OOT result in relation to previous time points using
  %change from initial, previous and average value
  Regression control chart
  Prediction interval for point
  Evaluation of the probability of the OOS result

Use case