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Tag: Stability of Recombinant Proteins

How to Ensure Compliance with Global Stability Testing Requirements (US FDA, EMA, WHO)

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How to Ensure Compliance with Global Stability Testing Requirements (US FDA, EMA, WHO) Ensuring Compliance with International Stability Testing Standards: A Comprehensive Guide Introduction Stability testing is a critical aspect of pharmaceutical development and quality assurance. Ensuring compliance with global stability testing requirements is essential for the approval, distribution, and maintenance of drug products in…

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  • Create a Stability Protocol Summary for Each Product and Study Type

    Understanding the Tip: Why stability protocols need product-specific summaries: Each pharmaceutical product has unique characteristics—formulation type, packaging, intended market, and shelf-life expectations—that influence how its… Read more

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