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Pharma Stability: Insights, Guidelines, and Expertise

Tag: pharmaceutical freeze thaw design

Implementing ICH Q1A in Freeze-Thaw Study Design

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Implementing ICH Q1A in Freeze-Thaw Study Design Designing Freeze-Thaw Studies According to ICH Q1A Guidelines The International Council for Harmonisation (ICH) Q1A(R2) guideline is the global reference for stability testing of new drug substances and products. While the guideline focuses primarily on long-term, intermediate, and accelerated stability conditions, its principles also guide the design of…

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Freeze-Thaw and Thermal Cycling Studies, Stability Testing Types

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  • Track Trends and Promptly Flag OOS/OOT Data in Stability Studies

    Understanding the Tip: Why trend analysis matters in stability programs: Trend analysis in stability studies provides insights into the gradual evolution of product quality over… Read more

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