统计方法在药品质量控制和质量保证中的应用综述

Aishwarya Karan, Venkatesan Jayaprakash, Manik Ghosh
{"title":"统计方法在药品质量控制和质量保证中的应用综述","authors":"Aishwarya Karan, Venkatesan Jayaprakash, Manik Ghosh","doi":"10.14805/jphchem.2022.art122","DOIUrl":null,"url":null,"abstract":"Global competitions have made the pharmaceutical industry undergo numerous obstacles to meet up with the pace of drug discovery, growth and expansion. In order to effectively manufacture a quality product, statistical methods can be implemented for continuous improvement. Evolution in quality is accessed by determining the beneficial effects due to changes in process performance. The use of statistical tools and statistical methods have increased exponentially to meet specifications of quality during the development of pharmaceutical product. Statistical process control is a segment of industrial statistics utilized for the continuous improvement in the product quality. Statistical process control technique is a method to analyse any variation by the process of timely evaluation of the manufacturing procedure.","PeriodicalId":14317,"journal":{"name":"International Journal of Pharmaceutical Chemistry","volume":"41 1","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2022-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Review on statistical methods applied in pharmaceutical quality control and quality assurance\",\"authors\":\"Aishwarya Karan, Venkatesan Jayaprakash, Manik Ghosh\",\"doi\":\"10.14805/jphchem.2022.art122\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Global competitions have made the pharmaceutical industry undergo numerous obstacles to meet up with the pace of drug discovery, growth and expansion. In order to effectively manufacture a quality product, statistical methods can be implemented for continuous improvement. Evolution in quality is accessed by determining the beneficial effects due to changes in process performance. The use of statistical tools and statistical methods have increased exponentially to meet specifications of quality during the development of pharmaceutical product. Statistical process control is a segment of industrial statistics utilized for the continuous improvement in the product quality. Statistical process control technique is a method to analyse any variation by the process of timely evaluation of the manufacturing procedure.\",\"PeriodicalId\":14317,\"journal\":{\"name\":\"International Journal of Pharmaceutical Chemistry\",\"volume\":\"41 1\",\"pages\":\"\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2022-01-30\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Pharmaceutical Chemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.14805/jphchem.2022.art122\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Pharmaceutical Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.14805/jphchem.2022.art122","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

全球竞争使制药业经历了许多障碍,以跟上药物发现、增长和扩张的步伐。为了有效地制造高质量的产品,可以采用统计方法进行持续改进。通过确定由于过程性能变化而产生的有益影响,可以获得质量的演变。在药品开发过程中,为了满足质量要求,统计工具和统计方法的使用呈指数级增长。统计过程控制是工业统计的一部分,用于产品质量的持续改进。统计过程控制技术是一种通过对生产过程进行及时评价来分析任何变化的方法。
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
Review on statistical methods applied in pharmaceutical quality control and quality assurance
Global competitions have made the pharmaceutical industry undergo numerous obstacles to meet up with the pace of drug discovery, growth and expansion. In order to effectively manufacture a quality product, statistical methods can be implemented for continuous improvement. Evolution in quality is accessed by determining the beneficial effects due to changes in process performance. The use of statistical tools and statistical methods have increased exponentially to meet specifications of quality during the development of pharmaceutical product. Statistical process control is a segment of industrial statistics utilized for the continuous improvement in the product quality. Statistical process control technique is a method to analyse any variation by the process of timely evaluation of the manufacturing procedure.
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
自引率
0.00%
发文量
0
期刊最新文献
Stability indicating novel analytical method development by RP-UPLC for the estimation of Gitingensine in bulk Review on statistical methods applied in pharmaceutical quality control and quality assurance To study the incidence of pre-hospital antibiotic therapy among critically ill patients admitted in rural tertiary care hospital Herbal drugs: Boon for Peptic ulcer patients Tuberculous Meningitis with dengue – A rare case
×
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