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Pharma Stability: Insights, Guidelines, and Expertise

Tag: shelf life ICH Q1A

Role of ICH Q1A (R2) in Stability Study Planning

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Role of ICH Q1A (R2) in Stability Study Planning How ICH Q1A (R2) Shapes the Planning of Stability Studies in Pharmaceuticals The International Council for Harmonisation (ICH) Q1A (R2) guideline is the global standard for stability testing of new drug substances and products. This regulatory framework guides the pharmaceutical industry on how to design, conduct,…

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  • Store Stability Samples from Validated Commercial Batches for Accurate Shelf-Life Data

    Understanding the Tip: Why commercial validation matters in stability studies: Stability data is used to determine how long a product remains safe and effective under… Read more

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