An application of the Mantel-Haenszel statistic in process validation

被引：0

作者：

Fairweather, WR ^{[1
]}

机构：

[1] Flower Valley Consulting Inc, Rockville, MD 20853 USA

来源：

JOURNAL OF BIOPHARMACEUTICAL STATISTICS | 2005年 / 15卷 / 02期

关键词：

analytical laboratory; bioequivalence study; data discrepancies; data mining; exploratory data analysis; immediate neighborhood; Mantel-Haenszel; process validation;

D O I：

10.1081/BIP-200048828

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

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.

引用

页码：253 / 264

页数：12

共 50 条

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