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Pharma Stability: Insights, Guidelines, and Expertise

Tag: ICH Q1D

Use Bracketing and Matrixing Effectively in Stability Studies for Product Variants

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Understanding the Tip: What are bracketing and matrixing: Bracketing and matrixing are scientifically justified designs used to reduce the number of stability tests required when dealing with multiple strengths, fill volumes, or packaging sizes of a single product line. Bracketing tests only the extremes (e.g., lowest and highest strengths), while matrixing staggers time point testing…

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