Products description

• Technical Sheet :

Stabelity is software dedicated to the evaluation of long-term stability data. It allows you to determine a retest period or shelf-life for a drug substance or product (pharmaceutical or biological).

Stabelity features:

• Reports one-sided or two-sided confidence intervals for the retest period or shelf-life using either fixed or random batch regression models.
• Able to model analytical method variability via nested errors models.
• Uses statistical methods that are compliant with FDA, ICH and WHO stability guidelines.
• Provides clear graphical representation of the results.
• Statistically compares regression lines using ANCOVA models to determine if data from multiple lots can be pooled.
• Checks the normality of the data.
• Checks for potential outliers in the data.
• Provides batch release limits.
• Can apply the ICH recommended approach for the computation for the shelf-life or retest-period.
• Generates a stand-alone (eCTD compliant) report with results of all statistical analyses.
• Internet based application on a secured web-site (https://). No installation and maintenance cost. Always the most up to date version available.
• 21 CFR Part 11 compliant.
• SAS based statistical analyses.
• SAS not required on your system.

Available statistical methodologies to estimate the regression models:

• FDA SAS macro-Linear Regression.
• Fixed batches-ANCOVA.
• Fixed batches with nested errors-ANCOVA.
• Random batches.
• Random batches with nested errors.

Available kinetics models:

• Zero-order linear regression.
• Zero-order quadratic regression.
• First-order log linear regression.

Other data transformations:

• Square-root(Y) linear regression.
• Reciprocal-Y regression.