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Product Shelf-Life Extension Based on Statistical Analysis of the Collected Stability Data

 Product Shelf-Life Extension Based on Statistical Analysis of the Collected Stability Data


Inna Ben-Anat, Teva Pharmaceuticals USA

The Food and Drug Administration requires pharmaceutical companies to establish a shelf life for all new drug products through a stability analysis.  This is done to ensure the quality of the drug taken by an individual is within established levels. Stability testing is a routine procedure performed on drug substances and products. In early stages, accelerated stability can be used as a “worst case” evaluation to determine what types of degradation products may be found after long-term storage. Testing under more gentle conditions (those recommended for long-term shelf storage), and slightly elevated temperatures, can be used to determine a product’s shelf life and expiration dates. According to FDA guidelines, ICH Q1A (R2) -Stability Testing of New Drug Substances and Product, a suitable statistical method should be used for the stability data evaluation in order to establish product shelf life: shelf life will be determined based on the time at which the 95% confidence limit for the mean curve (CI) of the stability response intersects the acceptance criteria. Using JMP software, collected data can be easily analyzed and shelf life can be determined. Shelf Life extension may be recommended, with the support of the statistical analysis, which can potentially save companies a lot of money and resources, having the product on the shelves for several years longer.


 Very informative article. Please suggest how to do multiple factor combination stability extrapolation in JMP other than time and batch factor as per ICH Q1E section B.3.2.2 .


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