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Pharma Stability: Insights, Guidelines, and Expertise

Tag: ongoing stability justification

Intermediate Stability Testing in Lifecycle Management

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Intermediate Stability Testing in Lifecycle Management Strategic Role of Intermediate Stability Testing in Product Lifecycle Management As pharmaceutical products evolve from development to commercialization and through their lifecycle, changes to manufacturing sites, formulations, packaging, and analytical methods become necessary. These changes must be supported by robust stability data to demonstrate continued product integrity. Intermediate stability…

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  • Review Thermal Cycling Impact During Packaging Development and Stability

    Understanding the Tip: What is thermal cycling and why it matters: Thermal cycling refers to repeated temperature fluctuations that pharmaceutical products may experience during storage,… Read more

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