How to Align Your Stability Study with ICH Q8 Principles
In today’s regulatory environment, pharmaceutical companies are expected not just to validate their products, but to develop them intelligently. This is where ICH Q8: Pharmaceutical Development enters the picture. When applied to stability testing, ICH Q8 helps sponsors design studies based on science, risk, and quality—key elements of the Quality by Design (QbD) approach. 🎯…
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