PS Dissolution Profile Comparison

The module is used to evaluate the similarity between the dissolution profiles of the tested product and reference product. The method used in the module are in accordance with the recommendations contained in the regulations of the European Agency EMA and the U.S. FDA.

Basic module functions:

  • Comparative analysis of dissolution profiles using the model -independent method: difference/similarity factors f1 and f2
  • Comparative dissolution profiles using the model-independent methods: bootstrap difference factor f1 and similarity factor F2
  • Comparative dissolution profiles using the methods of the model-independent method: a multivariate statistical distance
  • Comparative dissolution profiles using the model-dependent method for 12 theoretical dissolution models
  • 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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