의약품 함량분석 정도관리에서의 변이 요인에 대한 통계분석

Abstract

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 sourcesof 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 companiesin KyungIn province in Korea in the year of 200. 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-analytical results, absolute diferences 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 internalstandards in gas chromatographic analysis, participants' academic background and the yearly production sizes of phar-maceutical companies showed statistically significant influence to the accuracy and the precision of the reported analyticalresults used in this study.Key wordsProficiency test, Accuracy, Precision, ANOVA