Include Three Primary Batches in Stability Studies for Robust Shelf-Life Support
Understanding the Tip: Why three batches are the standard: Stability studies based on a single batch provide limited insight into variability. Including three primary batches—manufactured at pilot or production scale—ensures that your data reflects consistent performance and accounts for batch-to-batch differences. This approach supports statistical evaluation and strengthens confidence in the proposed shelf life and…
Read More “Include Three Primary Batches in Stability Studies for Robust Shelf-Life Support” »