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shu4455742

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Uncertainty of quantitative microbiological methods of pharmaceutical analysis
The total uncertainty of quantitative microbiological methods, used in pharmaceutical analysis, consists of several components. The analysis of the most important sources of the quantitative microbiological methods variability demonstrated no effect of culture media and plate-count techniques in the estimation of microbial count while the highly significant effect of other factors (type of microorganism, pharmaceutical product and individual reading and interpreting errors) was established. The most appropriate method of statistical analysis of such data was ANOVA which enabled not only the effect of individual factors to be estimated but also their interactions. Considering all the elements of uncertainty and combining them mathematically the combined relative uncertainty of the test results was estimated both for method of quantitative examination of non-sterile pharmaceuticals and microbial count technique without any product. These data did not exceed 35%, appropriated for a traditional plate count methods.
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baoshanqiu

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shu4455742(fjtony163代发): 金币+15, 代发 2016-03-16 17:47:44
fjtony163: 翻译EPI+1, 代发 2016-03-16 17:47:49
药物分析中定量微生物学方法的不确定性
用于药物分析的定量微生物学方法总的不确定性来源于几个方面。对定量微生物学方法变异性最主要来源的分析表明培养基和平板计数的方法对微生物数量的估算没有影响,而确立了有极显著影响的其它因素(微生物类型、药物产品和个人读数以及解释的误差)。对这类数据最恰当的统计学方法是方差分析,它不仅可以估计单个因素的效应,也能分析因素间的相互作用。对所有不确定性因素加以考虑并用数学方法将它们联合起来。对非消毒药物的定量检测和那些没有任何结果的微生物计数方法同时进行了测试结果的联合相对不确定性评估。这类数据不超过35%,适合于传统的平板计数法。
2楼2015-12-31 00:52:52
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