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Arlenda Newsletter

We are proud to announce that version 3.0 of our software Stab.e.lity has been released!

Analyse your stability data and generate reports in only a few seconds. It’s accurate, flexible and compliant with authority requirements (FDA, ICH, GAMP 5, 21 CFR part 11, etc).

Version 3.0 includes the following modules:

  1. Study design
  2. Shelf-life & Release Limits computation
  3. Accelerated testing
  4. Commercial Stability (Out-of-trend / out-of-specification) new since V3.0

Study Design

A ‘Study design’ module based on ICH Q1D allows you to avoid testing all combinations of factors (such as the strength or packaging) of your stability design, thus saving time and reducing cost.

The number of required stability tests can be optimized by means of Bracketing or Matrixing designs, where the testing frequency is reduced or certain factor combinations are not tested at all, if justified.

Both designs permit users to generate an Excel spreadsheet based on a choice of parameters (level(s), design, targeted shelf-life, batches).

Users need simply select their options and generate an Excel spreadsheet, based on the information entered. These reports provide guidance on:

  • The total number of experiments that should be performed
  • The time-point at which each experiment should be conducted

Release Limits Computation

The ‘Shelf-life computation’ module permits the evaluation of long-term stability data.

It allows you to determine a retest period or the shelf-life for a drug substance or product (pharmaceutical or biological) using either fixed or random batch regression models.

It also provides a calculation of Shelf-life and Batch release limits.

Results of all statistical analyses (Regression, Shelf-life, Residuals and Normality, Outliers, Releases limits recalculation, …) are done using SAS and are presented in a standalone (eCTD compliant) report.

Accelerated Testing

The ‘Accelerated testing’ module can be used to analyse stability studies which have been carried out under exaggerated/stressed conditions (conditions that increase the rate of chemical or physical degradation of a drug substance or product).

Data reported from this module can be used to assess longer term chemical effects at non accelerated conditions and evaluate the effect of short term excursions outside the label storage conditions such as might occur during shipping.

Commercial Stability

Out-of-trend / Out-of-specification, new since V3.0

The ‘Commercial (OOT/OOS)’ module provides a choice of four different analyses allowing you to test the validity of a commercial batch, using historical data as a basis for comparison.

  • Out-of-trend analysis for a single observation: allows you to verify if the selected observation is within the 1-alpha% prediction interval at a selected time.
  • Out-of-trend analysis for a batch: allows you to verify whether the slope of the commercial batch is significantly different from the slope of the historical batches by checking that 0 is not included within the 1-alpha% confidence interval computed on differences between the slopes of the historical and commercial batches.
  • Out-of-specification analysis: allows you to verify that all the points of the commercial batch are within the specification limits.
  • Shelf-life analysis: allows you to compute the shelf-life of the commercial batch using a common error model combining the data from the historical batches with the commercial batch.

Get direct access for direct access to the FULLY VALIDATED RELEASE (if you are a registered user) or fill-in the online DEMO-REQUEST FORM available for a FREE 15-day TRIAL on our demo version!

Explore our other web-based software applications: E.noval and Seelva for the validation of analytical procedures, as well as Transval for the transfer of assays.

info@arlenda.comdev.arlenda.be

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