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Pharma Stability: Insights, Guidelines, and Expertise

Tag: ICH Q1E statistics

Biostatistical Tools for Long-Term Stability Data Review

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Biostatistical Tools for Long-Term Stability Data Review Biostatistical Tools for Long-Term Stability Data Review in Pharmaceuticals Long-term stability studies are vital for defining a pharmaceutical product’s shelf life, supporting regulatory submissions, and ensuring product quality over time. But raw data alone doesn’t tell the full story—biostatistical tools must be applied to analyze, interpret, and predict…

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Intermediate and Long-Term Stability Testing, Stability Testing Types

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  • Calibrate and Validate RH Sensors and Data Loggers to Maintain Stability Compliance

    Understanding the Tip: Why RH sensors and data loggers require control: Relative humidity (RH) sensors and data loggers are essential for ensuring that stability chambers… Read more

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