Out of trend (OOT) Notes pdf

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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