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Pharma Stability: Insights, Guidelines, and Expertise

Tag: ICH Q1A zone assignment

Climatic Zone-Based Long-Term Study Design for Stability Testing

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Climatic Zone-Based Long-Term Study Design for Stability Testing Designing Long-Term Stability Studies Based on Climatic Zones: A Global Strategy Pharmaceutical products are distributed across a wide range of geographical regions, each with unique environmental conditions. Long-term stability studies must reflect these regional differences to ensure that drug quality is maintained throughout the product’s lifecycle. Climatic…

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  • Use Statistical Tools to Evaluate Analytical Trends in Stability Studies

    Understanding the Tip: Why visual inspection isn’t enough: Visually scanning stability data can give a false sense of consistency or overlook subtle trends that indicate… Read more

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