Tag: Long-Term Testing

Follow ICH-Compliant Sampling Intervals for Accurate Stability Assessment

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Understanding the Tip: Why structured sampling intervals matter: Stability testing isn’t just about storing products—it’s about analyzing them at critical intervals to track changes over time. Structured sampling intervals are essential to detect degradation trends and determine shelf life accurately. Missing key time points can lead to incomplete datasets, failed regulatory audits, or inaccurate product…

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Stability Study Tips

Optimize Stability Timelines by Starting Real-Time and Accelerated Studies Together

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Understanding the Tip: Why initiate both studies together: Starting real-time and accelerated stability studies simultaneously ensures comprehensive data collection from day one. Real-time data builds the case for long-term shelf life, while accelerated data offers early insights into product behavior under stress. This dual-track approach avoids delays in development and supports faster decision-making for regulatory…

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Stability Study Tips

Run Real-Time and Accelerated Stability Studies in Parallel

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Understanding the Tip: Why initiate both studies together: Starting real-time and accelerated stability studies simultaneously ensures comprehensive data collection from day one. Real-time data builds the case for long-term shelf life, while accelerated data offers early insights into product behavior under stress. This dual-track approach avoids delays in development and supports faster decision-making for regulatory…

Read More “Run Real-Time and Accelerated Stability Studies in Parallel” »

Stability Study Tips