ICH Q8 Guidelines for QbD-Based Stability Design
The ICH Q8 (R2) guideline is a cornerstone document in pharmaceutical development, laying the foundation for Quality by Design (QbD) approaches. Stability studies, when aligned with QbD and ICH Q8, can move from routine testing to strategic quality tools. This tutorial breaks down how to use ICH Q8 principles to design scientifically sound, risk-based, and…
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