实验设计(DoE)在制药工业两个案例研究中的应用

IF 1.1 Q4 CHEMISTRY, ANALYTICAL

Brazilian Journal of Analytical Chemistry Pub Date : 2023-10-17 DOI:10.30744/brjac.2179-3425.ar-56-2023

Romero Souza, Luiz Bonamichi, Edenir Pereira-Filho

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引用次数: 0

摘要

本研究说明了实验设计(DoE)在制药行业两个现实场景中的实际应用。第一个案例涉及优化测定多种分析物及其降解产物的色谱方法。研究的主要变量是梯度时间，在pH值为2时获得最有利的结果。在第二种情况下，我们对一种兽药进行了保质期研究，发现瓶子填充变量具有统计学上显著的影响(p值<0.05)。在这两种情况下，纳入DoE在确保获得可靠和统计上有效的结果方面发挥了重要作用。

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Design of Experiments (DoE) Application in Two Cases of Study in Pharmaceutical Industries

This study illustrates the practical application of Design of Experiments (DoE) in two real-life scenarios within the pharmaceutical industry. The first case involved optimizing a chromatographic method for the determination of multiple analytes and their degradation products. The primary variable of interest was gradient time, and the most favorable outcomes were achieved at a pH value of 2. In the second case, we conducted a shelf-life study for a veterinary product, revealing that the vial filling variable exerted a statistically significant impact (p-value < 0.05). The incorporation of DoE in both cases played an important role in ensuring the attainment of dependable and statistically validated results.

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来源期刊

Brazilian Journal of Analytical Chemistry CHEMISTRY, ANALYTICAL-

CiteScore

1.60

自引率

14.30%

发文量

期刊介绍： BrJAC is dedicated to the diffusion of significant and original knowledge in all branches of Analytical Chemistry, and is addressed to professionals involved in science, technology and innovation projects at universities, research centers and in industry.