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Pharma Stability: Insights, Guidelines, and Expertise

Tag: stability data interpretation pooling

Sample Pooling Practices in Long-Term Stability Studies

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Sample Pooling Practices in Long-Term Stability Studies Sample Pooling Practices in Long-Term Stability Studies: Design, Justification, and Regulatory Insights Long-term stability testing of pharmaceutical products is essential to support shelf-life claims, monitor degradation trends, and ensure compliance with ICH, FDA, EMA, and WHO guidelines. With increasing product complexity and testing volumes, the concept of pooling…

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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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