Out-of-trend (OOT) Notes pdf
Out-of-trend (OOT) is a result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stability study.
Contents of Out-of-trend (OOT) Notes pdf
- What is Out of trend (OOT)?
- Criteria to consider the result as OOT
- Reasons behind OOT
- Methods for Identifying OOT
- Types of OOT Determinations: Regression Control Chart Method; By Time Point Method
- OOT Cycle
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- Out of trend (OOT) Notes pdf