Level: Intermediate
Thomas Brisset, Stability Platform Manager, Stallergenes Greer
Stability studies are a key part of pharmaceutical product development. They help justify shelf and storage conditions. By using a stability data modeling approach, the laboratory can characterize its product and perform shelf life extrapolation. This approach can help also in the definition of acceptance criteria of quantitative parameters. In the context of biological product development, we studied physico-chemical and immunological parameters using different JMP platforms - Graph Builder, Linear Model, Stability - which integrates regulatory constraints. The objective of the presentation is to explain the approach to study stability data, to highlight the different issues and to exhibit how statistical modeling can represent a decision support process.
Pharmaceutical Guidelines mentioned in this presentation: US FDA Q1E Evaluation of Stability Data.
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