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药物分析中的测量不确定度及其应用。

Measurement uncertainty in pharmaceutical analysis and its application.

作者信息

Traple Marcus Augusto Lyrio, Saviano Alessandro Morais, Francisco Fabiane Lacerda, Lourenço Felipe Rebello

机构信息

Department of Pharmacy, Faculty of Pharmaceutical Sciences, University of São Paulo, São Paulo 05508-900, Brazil.

出版信息

J Pharm Anal. 2014 Feb;4(1):1-5. doi: 10.1016/j.jpha.2013.11.001. Epub 2013 Nov 20.

DOI:10.1016/j.jpha.2013.11.001
PMID:29403863
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5761051/
Abstract

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.

摘要

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。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8cf/5761051/cd2fed477a81/fx00.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8cf/5761051/29891f9e9ed0/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8cf/5761051/0f2c5ad4aa5c/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8cf/5761051/cd2fed477a81/fx00.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8cf/5761051/29891f9e9ed0/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8cf/5761051/0f2c5ad4aa5c/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8cf/5761051/cd2fed477a81/fx00.jpg

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J Pharm Biomed Anal. 2014 Jan;88:513-8. doi: 10.1016/j.jpba.2013.10.004. Epub 2013 Oct 14.
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How pH, Temperature, and Time of Incubation Affect False-Positive Responses and Uncertainty of the LAL Gel-Clot Test.pH值、温度和孵育时间如何影响鲎试剂凝胶法检测的假阳性反应和不确定性
PDA J Pharm Sci Technol. 2012 Nov-Dec;66(6):542-6. doi: 10.5731/pdajpst.2012.00887.
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Comparison of the quantitative performances and measurement uncertainty estimates obtained during method validation versus routine applications of a novel hydrophilic interaction chromatography method for the determination of cidofovir in human plasma.
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J Pharm Biomed Anal. 2012 Jan 5;57:153-65. doi: 10.1016/j.jpba.2011.08.040. Epub 2011 Sep 10.
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Uncertainty of measurement and conformity assessment: a review.测量不确定度和合格评定：综述。
Anal Bioanal Chem. 2011 Jun;400(6):1729-41. doi: 10.1007/s00216-011-4776-y. Epub 2011 Feb 25.
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