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Pharma Stability: Insights, Guidelines, and Expertise

Tag: lyophilized stability short-term testing

Freeze-Thaw Cycle Optimization for Reduced Study Time

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Freeze-Thaw Cycle Optimization for Reduced Study Time Freeze-Thaw Cycle Optimization for Reduced Study Time in Pharmaceutical Stability Studies Freeze-thaw stability studies are a critical component of pharmaceutical development, especially for cold chain products like biologics, vaccines, and emulsions. Traditionally, these studies involve multiple freeze-thaw cycles spanning weeks, which can delay development timelines. However, with a…

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  • 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… Read more

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