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AN APPLICATION OF THE MANTEL-HAENSZEL STATISTIC IN PROCESS VALIDATION

Authors: William R, Fairweather;

AN APPLICATION OF THE MANTEL-HAENSZEL STATISTIC IN PROCESS VALIDATION

Abstract

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.

Keywords

Pharmaceutical Preparations, Therapeutic Equivalency, Data Interpretation, Statistical, Humans, Reproducibility of Results, Pharmacokinetics, Algorithms, Blood Chemical Analysis, Chemistry Techniques, Analytical, Chromatography, High Pressure Liquid

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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average
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