Level: Intermediate Job Function: Analyst / Scientist / Engineer Jakob Christensen, Senior Consultant, NNE Christian Ramskov, Consultant Analyst, NNE The pharma industry executes accelerated stability studies to determine and confirm the shelf life of its products. Typical practice is to estimate the shelf life from the worst of three first (random) batches with confidence, following the ICH guidelines. However, ongoing verification batches can indeed fail, since there is a risk that a worse batch will appear in the future. Another challenge is that measurement system noise might be higher than the actual drug product degradation, and that the shelf life is estimated on sparse data. One solution is to suppress measurement noise by using a combined Arrhenius modelling system across all available conditions and time points. By combining all data in one model using mechanistic understanding, robust assessments of the stability can be achieved, both for determination and ongoing verification. This can also lead to increased scientific understanding of the degradation mechanism, and bridge the link between clinical stability studies carried out in development with registration stability. Both the standard ICH module and Arrhenius transformation are built-in functionality in JMP. By combining these tools and using data from all conditions, a “master decay curve” can easily be resolved to describe the stability for a product. The method has the potential to reduce the number of non-conformities, simplify the ongoing verification and give a faster determination of shelf life.
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