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Abstract:
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Stability studies are performed in the pharmaceutical industry to determine how long a pharmaceutical product (be it a vaccine, a biologic, or a small molecule) can be stored at specific conditions. They help establishing the expiry date for the product as well as storage recommendations (freezer, fridge, …). The ICH Q1E recommends testing three batches of the product and taking the worst of these three batches to determine the product shelf-life. The recommended approach is inherently flawed and discourages companies to test more batches to gain more information about their product. More appropriate models can provide a much better estimate of the product shelf-life but tend to require sample sizes that may be costly to obtain. Using informative prior distribution allow to use those models with less data. This talk will show the “how-to”, as well as present a case study.
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