基于现行美国和印度尼西亚药典的准确度和精密度评价的应用:综述

IF 0.8 Q3 MULTIDISCIPLINARY SCIENCES
G. Indrayanto
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引用次数: 0

摘要

最新版美国药典(USP)中提到了准确度和精密度评价的新方法,而其他验证参数,即选择性、线性、范围和鲁棒性保持相对不变。为了从任何化学/药物分析中获得可靠的数据,分析方法必须按照最新版本的药典进行验证或验证。作者已经发表了一些关于一般验证方法的综述文章。本文将重点介绍基于现行美国药典和印尼药典的准确度和精密度评价的实施和讨论。文中还讨论了几种精度的计算实例和精度的确定方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Application of Accuracy and Precision Evaluations Based on the Current United States and Indonesian Pharmacopoeias: A Critical Review
New methods for the evaluation of accuracy and precision are mentioned in the latest edition of the United States Pharmacopoeia (USP), whereas other validation parameters, that is, selectivity, linearity, range, and robustness, remained relatively unchanged. In obtaining reliable data from any chemical/pharmaceutical analysis, the analytical procedure must be validated or verified in accordance with the latest edition of the pharmacopoeia. Some review articles on the general validation methods have been published by the author. This present review will focus on the implementation and discussion of the accuracy and precision evaluation based on the current USP and Indonesian pharmacopoeia. Some examples of the calculation of several accuracy and precision method of determinations are also discussed.
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来源期刊
Makara Journal of Science
Makara Journal of Science MULTIDISCIPLINARY SCIENCES-
CiteScore
1.30
自引率
20.00%
发文量
24
审稿时长
24 weeks
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