全面回顾了QbD驱动的分析方法，用于分析各种药物

IF 1 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of Liquid Chromatography & Related Technologies Pub Date : 2023-03-16 DOI:10.1080/10826076.2023.2204238

Aggarapu Susmitha, G. Rajitha, Gireesh Kumar Eri

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引用次数: 0

摘要

摘要随着ICH等监管组织制定建议，质量一直是制药行业的首要任务。ICH Q8至Q10的概念是QbD方法论的基础，这是一种系统的药物开发方法。制药行业采用了QbD方法来支持生产过程中的产品质量，并改进稳健的生产流程。分析程序开发中采用的QbD是AQbD，即设计分析质量。它有助于可靠、经济的分析程序开发，也有助于监管的灵活性。这篇综述阐述了AQbD和DoE技术应用于各种分析技术的各个步骤的详细方面和相关例子，用于药物化合物测定的分析程序开发。使用AQbD创建的技术概述有助于该研究领域的方向。视觉摘要

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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

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来源期刊

Journal of Liquid Chromatography & Related Technologies 化学-分析化学

CiteScore

2.80

自引率

0.00%

发文量

审稿时长

4.9 months

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.