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ICH Q1E and Stability Data Evaluation in Pharmaceutical Submissions

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ICH Q1E and Stability Data Evaluation in Pharmaceutical Submissions ICH Q1E and Stability Data Evaluation in Pharmaceutical Submissions Introduction Stability data forms the foundation for assigning pharmaceutical shelf life and defining product storage conditions. However, collecting data is only half the task—the analysis and interpretation of this data must be scientifically rigorous and statistically sound….

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ICH Q1E and Stability Data Evaluation, Protocols and Reports

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  • Perform Humidity-Dependency Testing for Hygroscopic Formulations

    Understanding the Tip: Why humidity poses a risk to hygroscopic products: Hygroscopic formulations—such as certain tablets, powders, and granules—readily absorb moisture from the environment.
    This… Read more

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