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Pharma Stability: Insights, Guidelines, and Expertise

Tag: post-approval stability requirements

Bridging Data Across Long-Term Studies During Product Lifecycle Changes

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Bridging Data Across Long-Term Studies During Product Lifecycle Changes Strategies for Bridging Stability Data Across Long-Term Studies During Product Lifecycle Changes Throughout a pharmaceutical product’s lifecycle, changes in manufacturing site, formulation, packaging, or analytical methods are inevitable. Each of these changes poses a risk to the stability profile of the product, which must be addressed…

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  • Include Microbial Limits Testing in Stability Studies Where Applicable

    Understanding the Tip: What is microbial limits testing in stability studies: Microbial limits testing evaluates the total microbial count and the presence of specific objectionable… Read more

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