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Tag: extrapolation of shelf life

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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