Traple Marcus Augusto Lyrio, Saviano Alessandro Morais, Francisco Fabiane Lacerda, Lourenço Felipe Rebello
Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-900, Brazil.
J Pharm Anal. 2014 Feb;4(1):1-5. doi: 10.1016/j.jpha.2013.11.001. Epub 2013 Nov 20.
The measurement uncertainty provides complete information about an analytical result. This is very important because several decisions of compliance or non-compliance are based on analytical results in pharmaceutical industries. The aim of this work was to evaluate and discuss the estimation of uncertainty in pharmaceutical analysis. The uncertainty is a useful tool in the assessment of compliance or non-compliance of in-process and final pharmaceutical products as well as in the assessment of pharmaceutical equivalence and stability study of drug products.
测量不确定度提供了关于分析结果的完整信息。这非常重要，因为在制药行业中，几个合规或不合规的决策是基于分析结果做出的。这项工作的目的是评估和讨论药物分析中不确定度的估计。不确定度是评估中间过程和最终药品是否合规以及评估药品等效性和稳定性研究的有用工具。
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