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Pharma Stability: Insights, Guidelines, and Expertise

Tag: stability study statistics

Using Statistical Tools to Interpret Accelerated Stability Data

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Using Statistical Tools to Interpret Accelerated Stability Data Applying Statistical Tools to Interpret Accelerated Stability Testing Data Accelerated stability studies offer pharmaceutical professionals rapid insight into the degradation behavior of drug products. However, interpreting these studies without robust statistical tools can lead to inaccurate conclusions, flawed shelf-life predictions, and regulatory pushback. This guide explores essential…

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  • Fully Validate Stability-Indicating Methods Before Use in Studies

    Understanding the Tip: What is a stability-indicating method: A stability-indicating method is an analytical procedure that accurately and specifically measures the active pharmaceutical ingredient (API)… Read more

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