By Thomas A. Little
Published in: thomasalittleconsulting.com
Published on: June 17, 2019
This paper defines the concept, justification and method of removal of out-of-trend points in stability modelling and shelf-life prediction. It provides the overview from literature, guidance and best analytical practice and the method to be used during stability modelling and analysis. A clearly defined OOT procedure is needed to correctly and consistently remove outliers from expiry and stability modelling and prediction where technically warranted.
