Include In-Use Stability Studies for Reconstituted and Multidose Formulations
Understanding the Tip: Why in-use studies are essential: In-use stability studies evaluate how a pharmaceutical product performs after it has been opened, reconstituted, or prepared for administration. This simulates real-world usage conditions—where contamination, moisture, or temperature shifts may alter the product’s stability. Such studies are critical for multidose containers, injectables that require dilution, or powders…
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