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Pharma Stability: Insights, Guidelines, and Expertise

Tag: regulatory stability stress tests

Implementing ICH Q1A in Freeze-Thaw Study Design

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Implementing ICH Q1A in Freeze-Thaw Study Design Designing Freeze-Thaw Studies According to ICH Q1A Guidelines The International Council for Harmonisation (ICH) Q1A(R2) guideline is the global reference for stability testing of new drug substances and products. While the guideline focuses primarily on long-term, intermediate, and accelerated stability conditions, its principles also guide the design of…

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  • Leverage Design of Experiments (DoE) in Early Stability Study Planning

    Understanding the Tip: What is DoE in the context of stability studies: Design of Experiments (DoE) is a structured, statistical approach to determine the relationship… Read more

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