生化工程
设计质量
药物开发
过程开发
计算机科学
风险分析(工程)
过程(计算)
工艺工程
药品
新产品开发
纳米技术
工程类
材料科学
药理学
医学
业务
营销
操作系统
作者
Bikash Ranjan Jena,Suryakanta Swain,A. Anka Rao,M. Narender,Naga Jogayya Kothakota,Satyanarayan Tripathy
出处
期刊:Current Pharmaceutical Biotechnology
[Bentham Science]
日期:2024-03-01
卷期号:25 (4): 385-395
标识
DOI:10.2174/1389201024666230726152629
摘要
The current review intends to regulate and accurately evaluate genotoxic contaminants in drug substance and drug product method and formulation process development, validation, and degradation pathways. The Quality by Design (QbD) principles can be applied to the systematic evaluation and control of impurities enabled by the development of modern analytical techniques, including the performance of risk assessment, the screening of Critical Process Parameters (CPPs), and the identification of the most influential variables in the optimization of the evaluation and control methods. Current difficulties in removing genotoxic contaminants and the procedures for doing so have been outlined in this review, along with the steps necessary to acquire optimum techniques and the most acceptable formulations. In addition to this, division, characterization, assessment, quantification, and formation of genotoxic impurities sources and control strategy for genotoxic impurities, handling of nitrosamine assay content of drug products in different industrial methodologies and their chemometric prospects and associated recent patents are also explored.
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