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Tag: field storage validation

Stability Testing for Humanitarian and Emergency Drug Supplies

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Stability Testing for Humanitarian and Emergency Drug Supplies Ensuring Drug Stability in Humanitarian and Emergency Response Scenarios Introduction Delivering pharmaceutical products during humanitarian crises—natural disasters, armed conflict, disease outbreaks, or refugee emergencies—requires more than rapid logistics and global coordination. These medicines must remain safe, effective, and stable under unpredictable, often harsh environmental conditions. Traditional stability…

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Stability Studies in Emerging Markets, Stability Testing for Humanitarian and Emergency Drug Supplies

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  • Start Stability Protocol Design with ICH Q1A(R2) Guidance

    Tip: Always refer to ICH Q1A(R2) before designing a stability protocol to align with global regulatory expectations.
    Understanding the Tip: Why protocol design matters: Stability protocols define how long a pharmaceutical product remains safe and effective… Read more

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