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Pharma Stability: Insights, Guidelines, and Expertise

Tag: statistical sampling stability

Designing Stability Protocols: Duration and Pull Point Strategy

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Designing Stability Protocols: Duration and Pull Point Strategy Designing a Stability Protocol: Duration and Pull Point Considerations Developing an effective stability protocol is crucial for determining the shelf life of pharmaceutical products. The duration and frequency of sample pull points directly influence data quality, regulatory compliance, and the success of a product submission. This tutorial-style…

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  • Match Stability Study Container-Closure Systems to Final Market Packaging

    Understanding the Tip: Why container-closure systems matter: Stability testing simulates how a drug product will behave over its shelf life.
    If the container-closure system used… Read more

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