A Statistical Decision System for Out-of-Trend Evaluation
By Niels Væver Hartvig, Liselotte Kamper
Pharmaceutical Technology
Volume 41, Issue 1, pg 34–43
"The authors present a set of statistical decision rules based on linear regression models that can be implemented in an automated trend system to assist stability studies. The models combine historical stability and analytical method data with data from stability studies, and allow the responsible person to routinely evaluate stability results based on statistical tools, without the need for expert statistical assistance. The system provides a fast and standardized framework for evaluating parameters that approximately follow a linear degradation path or are constant."
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