Confidence Beyond Compliance

Your focus: product stability

Your objectives:

  • Evaluate the long-term stability of your product and define its shelf-life
  • Define the release limits
  • Define the optimal experimental design to avoid testing all factor combinations
  • Set up a standard re-test period for your product
  • Identify out-of-trend results and batches
  • Predict long-term stability based on accelerated studies

Introducing Stab.e.lity

  • Stabelity generates statistics in compliance with regulatory documents such as WHO, ICH Q1A, ICH Q1B, ICH Q1C, ICH Q1E, ICH Q6A, ICH Q6B, ICH Q5C, ICH Q5E and ICH M4Q
  • Use of Bracketing or Matrixing designs to define the total number of experiments and the relevant time-points, avoiding to test all combinations of stability factors.
  • Use of either fixed or random batch regression models to calculate the shelf-life, the release limits or a re-test period:
    • Simple linear regression
    • Quadratic regression
    • Linear regression after square root transformation
    • Linear regression after logarithmic transformation
    • Linear regression after inverse transformation
    • Non-linear mono-exponential decay
  • Modeling of long-term shelf-life based on accelerated stability data with Arrhenius regression models
  • Assessment of out-of-trend/out-of-specification batches to define a reliable shelf-life
  • Generate an e-CTD compliant report within minutes, in full compliance with authority expectations, reporting in particularity one or two-sided confidence intervals for batch release limits, shelf-life and re-test period
  • Suitable for GxP use: fully validated according to the GAMP5 guidelines and 21 CFR part 11 compliant
  • Our statisticians provide a support (hotline) for any questions concerning the use of the software and the processing of your data
  • Software as a Service (SaaS) application:
    • no installation required: no need to validate the system on site
    • no maintenance costs
    • can be accessed from any location
    • always the latest version available, free of charge