Biological Products and Stability : Linear and Nonlinear Modeling (2020-EU-30MP-471)
Jan 30, 2020 11:03 AM
| Last Modified: Mar 17, 2020 04:36 PM
Exemple 1_prediction log.jmp
Exemple 1_prediction linéaire.jmp
JMP day T. Brisset_gbm.jrn
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.