蒙特卡罗模拟在风险评估中的应用基于设计质量原则的分析方法

Q Pharmacology, Toxicology and Pharmaceutics

Anales De La Real Academia Nacional De Farmacia Pub Date : 2022-12-31 DOI:10.53519/analesranf.2022.88.05.03

Fernando Ferrándiz Vindel

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引用次数: 0

摘要

蒙特卡罗模拟是确定进行分析开发测试的影响因素和时间间隔的有力工具，尽管它是一种数学模型，必须经过实验证实。在工作中获得和提出的结果证实，该工具允许对分析变异性的来源及其在风险评估阶段的重要性进行先前的分析。因此，随后的实验确认必须主要集中在蒙特卡罗模拟所揭示的变量的使用上，从而节省不为分析发展的全球过程增加价值的资源和时间。关键词:蒙特卡罗仿真;QbD;分析方法

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Application of the Montecarlo Simulation for risk assessment in the Development of an analytical method according to the principles of quality by design (QbD)

Montecarlo simulation is a powerful tool to identify influencing factors and intervals in which to carry out analytical development tests, although as it is a mathematical model, it must be experimentally confirmed. The results obtained and presented in the work confirm that this tool allows the previous analysis of the sources of analytical variability and its importance within the risk assessment phase. With this, the subsequent experimental confirmation must be mainly focused on the use of the variables revealed with the Montecarlo simulation, saving resources and time that do not add value to the global process of analytical development. Keywords: Montecarlo simulation; QbD; analytical method

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来源期刊

Anales De La Real Academia Nacional De Farmacia Pharmacology-

CiteScore

0.13

自引率

0.00%

发文量

期刊介绍： The Anales de la Real Academia Nacional de Farmacia� embraces all aspects of pharmaceutical sciences and is a quarterly journal that publishes basic and applied research on pharmaceutical sciences and related areas. It is a medium for reporting selected original and significant contributions to new pharmaceutical knowledge.