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Pharma Stability: Insights, Guidelines, and Expertise

Tag: accelerated protocols combination products

Emerging Trends in Accelerated Stability Testing for Combination Products

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Emerging Trends in Accelerated Stability Testing for Combination Products Trends in Accelerated Stability Testing for Combination Pharmaceutical Products Combination products — those that integrate drugs with devices, diagnostics, or biological components — present unique challenges in stability testing. From autoinjectors and inhalers to drug-coated stents and co-packaged therapies, these products require tailored approaches that account…

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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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