By Thomas A Little
Published in: Thomas A Little Consulting
Published on: November 5, 2024
OOT Determination is a powerful addition to any stability program and needs a clearly defined SOP to consistently apply the logic to day-to-day stability evaluation. Including an OOT protocol to stability testing and datam analysis will produce more statistically reliable stability determination and expiry prediction. OOT determination basedm on the protocol described in this paper opens the door for the automation of OOT determination and from any stability analysis and may be the best approach to systematically evaluate all time points in stability analysis.
