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Pharma Stability: Insights, Guidelines, and Expertise

Tag: accelerated testing biologics

Real-Time and Accelerated Stability Studies for Biologics

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Real-Time and Accelerated Stability Studies for Biologics Comprehensive Guide to Real-Time and Accelerated Stability Studies for Biologics Introduction Biologics, including monoclonal antibodies, recombinant proteins, vaccines, and biosimilars, are among the most complex and sensitive pharmaceuticals. Ensuring their stability over time is essential for regulatory approval, therapeutic efficacy, and patient safety. Real-time and accelerated Stability Studies…

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Biopharmaceutical Stability, Real-Time and Accelerated Stability Studies for Biologics

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  • Prepare Expiry Justification Reports to Support Regulatory Queries and Renewals

    Understanding the Tip: What are expiry justification reports: Expiry justification reports are formal documents that summarize the rationale behind an assigned shelf life.
    They compile… Read more

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