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KMID : 0369820070370010027
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Jorunal of Korean Pharmaceutical Sciences
2007 Volume.37 No. 1 p.27 ~ p.38
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Statistical Analysis on the Sources of Variance in Proficiency Test of Quantitative Analysis of Medicines
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Cho Jung-Hwan
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Abstract
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Proficiency test is an essential tool for ensuring analytical ability of analytical chemists and analytical insti- tutes. Usually, the standard protocol for proficiency test is focused on acceptability of reported analytical results of par- ticipants by calculating z-scores and related diagnostic parameters. The ultimate goal of this process is to reveal the sources of variability of analytical results and to find the way to reduce their influence. In this study, the method of analysis of vari- ance (ANOVA) was applied to the analytical data collected from quality control departments of pharmaceutical companies in KyungIn province in Korea in the year of 2000. As influencing factors of variability of analytical results, the use of inter- nal standards for liquid and gas chromatograpy, the educational and professional background of participants, geological loca- tions and yearly production sizes of participating companies were evaluated. To evaluate the variability in accuracy of analytical results, absolute differences from sample mean and sample median were used and to evaluate variability in pre- cision of individual participants, the reported standard deviation of each participant was used. As a result, the use of intermal standards in gas chromatographic analysis, participants academic background and the yearly production sizes of phar- maceutical companies showed statiscically significant influence to the accuracy and the precision of the reported analytical results used in this study.
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KEYWORD
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Proficiency test, Accuracy, Precision, ANOVA
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