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CELLULA-S helps you calculate a product Shelf Life or a Retest Period for your Product - based on a linear degradation rate (or build-up of impurities) for one or more batches of materials. It follows the ICH guideline Q1E for evaluating Stability Data by applying a regression analysis to your data, including a statistical test for batch poolability using the recommended 0.25 level of significance.
It helps you establish the earliest point where the 95% confidence limit for the mean intercepts the proposed acceptance criterion. According to whether the attribute under test is known either to i) increase with time, ii) decrease with time, or iii) where the direction of change is unknown, then CELLULA-S can apply either one-sided (upper or lower), or two-sided 95% confidence limits. You can also cover situations where multiple factors are involved in a full- or reduced-design study.
CELLULA-S Quick Tour
1. Select and fit a model
Simply ensure that your stability data is in Excel in simple list format (convert any pivot tables to list format). Then select CELLULA>Stability Analysis from the CELLULA menu on your Excel menu bar - and complete the dialogue box. That's all you need to do before hitting OK to create the CELLULA-S results page.
2. Check the adequacy of your model
As ever, all such analyses involve assumptions - and you need to confirm your assumptions in order to ensure the validity of your model. The CELLULA-S results page helps you check that the residuals (the observed vs the fitted values) are small and that they display no systematic pattern.
3. Review and present your results
CELLULA-S provides the results of an Analysis of Co-Variance (Comparison of the Means of the 3 batches in this example) showing the Slope and Intercept of each of the batches. It also tests for Parallelism (Equality of the Slopes) and Colinearity (Equality of the Intercepts) using the p-value of 0.25 so that you can test for batch poolability - and establish the overall Shelf Life.
4. Additional Capabilities
As well as calculating Shelf Life, CELLULA-S can help you establish related information from your data:
- Detection of Outliers (via Residual Plots)
- Trend Analyses
- Projections using one-sided or two-sided confidence intervals
And CELLULA-S comes packaged with fully-capable Linear Regression, ANCOVA and Basic Stats modules to help you extract and visualise the information within your data. You can read here about these features of CELLULA-S.
