PS Product Stability

The module is used to determine the shelf-life for single batches or multiple batches for one factor in accordance with the recommendations of ICHQ1E. B1 and ICHQ1E. B2 and trending of the results collected during ongoing stability studies, together with an assessment of the likelihood of the OOS result at the end of the shelf-life.

Basic module functions:

  • Determination of the shelf-life on the basis of the confidence interval and/or prediction interval
  • Linear statistical model selection with transformation or without transformation
  • Analyses of multiple batches with assessment of pooling data using an ANCOVA
  • Derivation of predicted values for the selected statistical model and time interval
  • Identification of atypical trends for a single timepoint and slope of regression line
  • Analysis of atypical trends in relation to the earlier time points and/or a historical batches
  • Analysis of the likelihood of OOS occurrence with regard to the earlier time points and/or historical batches
  • Configuration of the contents of a report with a choice of a range of statistical analysis and analyses criteria
  • Generation of reports in PDF/Word, including the English version
  • Creation of standardized templates that contain configured range of statistical analysis
  • Option: storing data in the database with audit trail

Questions? Please contact our specialist team.

info@statsoftpharma.com

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