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 Makara Journal of Science Pub Date : 2022-12-20 DOI:10.7454/mss.v26i4.1343
G. Indrayanto
{"title":"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","authors":"G. Indrayanto","doi":"10.7454/mss.v26i4.1343","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":18042,"journal":{"name":"Makara Journal of Science","volume":"83 1","pages":""},"PeriodicalIF":0.8000,"publicationDate":"2022-12-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Application of Accuracy and Precision Evaluations Based on the Current United States and Indonesian Pharmacopoeias: A Critical Review\",\"authors\":\"G. Indrayanto\",\"doi\":\"10.7454/mss.v26i4.1343\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":18042,\"journal\":{\"name\":\"Makara Journal of Science\",\"volume\":\"83 1\",\"pages\":\"\"},\"PeriodicalIF\":0.8000,\"publicationDate\":\"2022-12-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Makara Journal of Science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.7454/mss.v26i4.1343\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"MULTIDISCIPLINARY SCIENCES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Makara Journal of Science","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.7454/mss.v26i4.1343","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MULTIDISCIPLINARY SCIENCES","Score":null,"Total":0}
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。
查看原文
分享 分享
微信好友 朋友圈 QQ好友 复制链接
本刊更多论文
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.
求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
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
期刊最新文献
Assessment of Seasonal Variation in Heavy Metal Status of a Lotic Ecosystem in Federal Capital Territory, Abuja, North Central Nigeria An Inkjet-printed Graphene Oxide–poly(3,4-ethylenedioxythiophene) poly(styrene sulfonate) Electrode for Nitrite Detection in Water Enzymatic Screening and Genotypic Characterization of Thermophilic Bacteria from the Hot Springs of Sarawak, Malaysia Using In silico Tools to Analyze the 5ʹ Untranslated Regions of the Alcohol Dehydrogenase Gene from Arabidopsis thaliana and Omega Sequence Electro-optical Effect of 4-n-alkyl-sulfanyl-4' isothiocyanate-biphenyl Liquid Crystal Homologous Series Under Terahertz Frequency: A Theoretical Approach
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
现在去查看 取消
×
提示
确定
0
微信
客服QQ
Book学术公众号 扫码关注我们
反馈
×
意见反馈
请填写您的意见或建议
请填写您的手机或邮箱
已复制链接
已复制链接
快去分享给好友吧!
我知道了
×
扫码分享
扫码分享
Book学术官方微信
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术
文献互助 智能选刊 最新文献 互助须知 联系我们:info@booksci.cn
Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。
Copyright © 2023 Book学术 All rights reserved.
ghs 京公网安备 11010802042870号 京ICP备2023020795号-1