Handling Out-of-Trend Results in Long-Term Stability Studies
Handling Out-of-Trend Results in Long-Term Stability Studies Best Practices for Managing Out-of-Trend Results in Long-Term Stability Studies Out-of-Trend (OOT) results in long-term pharmaceutical stability studies are deviations in data that, while still within specification, fall outside expected variability patterns. Unlike Out-of-Specification (OOS) results, OOT events are subtler but can signal product degradation, analytical errors, or…
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