About this document
Identifying Out-of-Trend Results in Stability by Piruzi Maghlakelidze is a document available to read on EtoBox.
The document discusses three methods for identifying out-of-trend (OOT) results in stability studies: the regression-control-chart method, by-time-point method, and slope-control-chart method. It compares the z-score method and tolerance interval approach for defining limits to identify an OOT result. The authors analyze experimental stability data on a pharmaceutical product using the three OOT identification methods and discuss the need for regulatory guidelines on evaluating OOT results in ongoing stabil
- Author
- Piruzi Maghlakelidze
- Language
- EN