{"title":"全面回顾了QbD驱动的分析方法，用于分析各种药物","authors":"Aggarapu Susmitha, G. Rajitha, Gireesh Kumar Eri","doi":"10.1080/10826076.2023.2204238","DOIUrl":null,"url":null,"abstract":"Abstract Quality has been a prime priority for the pharmaceutical sector with the development of recommendations by regulatory organizations like ICH. Concepts of ICH Q8 to Q10 are the foundation of the QbD methodology, a systematic approach to pharmaceutical development. Pharma industries have adopted the QbD approach to support product quality during manufacturing and to improve robust manufacturing processes. QbD adoption in analytical procedure development is AQbD, Analytical Quality by Design. It aids in reliable, economical analytical procedure development and also facilitates regulatory flexibility. This review illustrates the detailed aspects with relevant examples in each step of AQbD and DoE techniques applied to various analytical techniques for analytical procedure development for the determination of medicinal compounds. The overview of techniques created using AQbD contributes to the direction in this field of study. Visual Abstract","PeriodicalId":16295,"journal":{"name":"Journal of Liquid Chromatography & Related Technologies","volume":null,"pages":null},"PeriodicalIF":1.0000,"publicationDate":"2023-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A comprehensive review on QbD driven analytical procedures developed for the analysis of various drugs\",\"authors\":\"Aggarapu Susmitha, G. Rajitha, Gireesh Kumar Eri\",\"doi\":\"10.1080/10826076.2023.2204238\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract Quality has been a prime priority for the pharmaceutical sector with the development of recommendations by regulatory organizations like ICH. Concepts of ICH Q8 to Q10 are the foundation of the QbD methodology, a systematic approach to pharmaceutical development. Pharma industries have adopted the QbD approach to support product quality during manufacturing and to improve robust manufacturing processes. QbD adoption in analytical procedure development is AQbD, Analytical Quality by Design. It aids in reliable, economical analytical procedure development and also facilitates regulatory flexibility. This review illustrates the detailed aspects with relevant examples in each step of AQbD and DoE techniques applied to various analytical techniques for analytical procedure development for the determination of medicinal compounds. The overview of techniques created using AQbD contributes to the direction in this field of study. Visual Abstract\",\"PeriodicalId\":16295,\"journal\":{\"name\":\"Journal of Liquid Chromatography & Related Technologies\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.0000,\"publicationDate\":\"2023-03-16\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Liquid Chromatography & Related Technologies\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://doi.org/10.1080/10826076.2023.2204238\",\"RegionNum\":4,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Liquid Chromatography & Related Technologies","FirstCategoryId":"92","ListUrlMain":"https://doi.org/10.1080/10826076.2023.2204238","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
A comprehensive review on QbD driven analytical procedures developed for the analysis of various drugs
Abstract Quality has been a prime priority for the pharmaceutical sector with the development of recommendations by regulatory organizations like ICH. Concepts of ICH Q8 to Q10 are the foundation of the QbD methodology, a systematic approach to pharmaceutical development. Pharma industries have adopted the QbD approach to support product quality during manufacturing and to improve robust manufacturing processes. QbD adoption in analytical procedure development is AQbD, Analytical Quality by Design. It aids in reliable, economical analytical procedure development and also facilitates regulatory flexibility. This review illustrates the detailed aspects with relevant examples in each step of AQbD and DoE techniques applied to various analytical techniques for analytical procedure development for the determination of medicinal compounds. The overview of techniques created using AQbD contributes to the direction in this field of study. Visual Abstract
期刊介绍：
The Journal of Liquid Chromatography & Related Technologies is an internationally acclaimed forum for fast publication of critical, peer reviewed manuscripts dealing with analytical, preparative and process scale liquid chromatography and all of its related technologies, including TLC, capillary electrophoresis, capillary electrochromatography, supercritical fluid chromatography and extraction, field-flow technologies, affinity, and much more. New separation methodologies are added when they are developed. Papers dealing with research and development results, as well as critical reviews of important technologies, are published in the Journal.
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