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Pharma Stability: Insights, Guidelines, and Expertise

Tag: resource-saving stability testing

Matrixing and Bracketing in Real-Time and Accelerated Stability Studies

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Matrixing and Bracketing in Real-Time and Accelerated Stability Studies Optimizing Real-Time and Accelerated Stability Studies with Matrixing and Bracketing Stability testing is essential to ensure the safety and efficacy of pharmaceutical products throughout their shelf life. However, traditional full-factorial designs for stability studies can be resource-intensive. To improve efficiency, ICH Q1D introduces two risk-based approaches…

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  • Evaluate Both Chemical and Physical Stability in Pharmaceutical Studies

    Understanding the Tip: Why both stability types are critical: Stability isn’t just about potency retention (chemical stability); it’s also about how the product looks, feels,… Read more

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