Statistical Data Analysis in iStability LIMS
iStability LIMS supports FDA/ICH recommended analysis methods out of the box; no need to acquire another module or statistical package, as our analysis tools are fully validated and have been used by industry professionals for over 30 years. Furthermore, no statistician will be required to understand our analysis reports, which are nicely formatted so you can incorporate into your final summary.
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Expiry Dating Calculation
Shelf life prediction: Calculate the expiry dating period using zero-, first-, or second-order kinetics and predict data at later time points. Graphs are beautiful and effortless to generate.
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Poolability Determination
Statistically compare data from multiple lots to determine if they can be pooled together. ANCOVA analysis according to ICH Q1E is used.
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Arrhenius Treatment
Process accelerated stability data using the Arrhenius equation to estimate expiry dating periods at any storage temperature. A perfect tool for formulators who do not have the luxury of time.
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Expiry Dating Simulation
Leverage your data to answer 'What if?' type questions. Calculate expiry dating periods under a variety of simulation conditions, such as determining expiry periods when the QC release data is lower than the acceptable release specification.
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Back Calculate Initial Purity
Determine the initial values needed to achieve a targeted expiry dating period, e.g. "what initial values are required to achieve a 36 month expiry dating period based on the existing stability data?".
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Polynomial Regression
Sometimes, traditional regression analysis based on zero-, first-, or second-order kinetics may not be suitable for analyzing your degradation. iStability LIMS provides a way to find the polynomial function that best fits your data set -- An industry first.
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