By Els van Deventer-Troost

Published in: Sci of Stability Conference

Published on: August 14, 2019

Conclusion Statement: ✓ Kinetic modeling can be used also when the degradation is not linear ✓ Good predictions of behavior at different temperatures – Different degradation routes at different temperatures ✓ Valuable predictions to support product development and impact assessments (e.g. temperature excursions) ▪ Fits based purely on mathematics, not on understanding of reaction mechanism – Information on mechanism obtained from fits ▪ Confidence intervals can get very large for longer-term predictions; input variability critical for output Key Words: Case, Develop, Biologic

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