An application of the Mantel-Haenszel statistic in process validation.
Discrepancies in the data of a bioequivalence study led to questions about the procedures used in the analytical laboratory. In this article we describe some statistical and graphical procedures that were used to explore the causes of a process failure for an unvalidated process.
Fairweather
William R
WR
Flower Valley Consulting, Inc, Rockville, MD 20853, USA. fairweather@flowervalleyconsulting.com
D000465:Algorithms; D001774:Blood Chemical Analysis; D002623:Chemistry Techniques, Analytical / Q000592:standards / Q000706:statistics & numerical data*; D002851:Chromatography, High Pressure Liquid; D003627:Data Interpretation, Statistical; D006801:Humans; D004364:Pharmaceutical Preparations / Q000097:blood; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D013810:Therapeutic Equivalency
D004364:Pharmaceutical Preparations