How to Handle Outliers in Q1E-Compliant Evaluation of Stability Data
In pharmaceutical stability studies, outliers can distort regression models, mislead shelf life estimations, and trigger regulatory scrutiny. ICH Q1E acknowledges the presence of statistical anomalies but requires robust justification before excluding any data point. This article explains how to detect, evaluate, and document outliers in Q1E-compliant submissions while maintaining regulatory integrity. ➀ Understanding What Constitutes…
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