Establishing robust stability profiles is essential yet challenging due to the limited understanding of degradation pathways and assay limitations. This session will focus on designing effective stress and accelerated stability studies, interpreting degradation data to support shelf-life and retest justifications, and navigating evolving regulatory expectations. Attendees will explore best practices for building confidence in product stability.

Key discussion points:

• Designing Meaningful Forced Degradation & Stress Studies: Share approaches to stress testing (thermal, agitation, oxidative, freeze-thaw) and how data informs product understanding and predictive modeling
• Selecting and Validating Stability-Indicating Assays: Discuss the assays best suited to monitor relevant CQAs, challenges in detecting subtle degradation, and how to ensure assay sensitivity and robustness
• Shelf-Life Justification & Regulatory Strategy: Explore how companies justify retest dates, handle data variability across sites, and build regulatory packages that withstand scrutiny for commercial approval