Prevent Data Pooling Across Batches Without Robust Statistical Justification
Understanding the Tip: Why pooling batch data may compromise stability analysis: Pooling stability data from different batches is sometimes used to generate average trends or support shelf-life extensions. However, this can mask batch-specific variations and dilute the visibility of anomalies. Inappropriately combined data may mislead reviewers and prevent accurate detection of degradation trends, particularly when…
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