{"title":"实验设计(DoE)在制药工业两个案例研究中的应用","authors":"Romero Souza, Luiz Bonamichi, Edenir Pereira-Filho","doi":"10.30744/brjac.2179-3425.ar-56-2023","DOIUrl":null,"url":null,"abstract":"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.","PeriodicalId":9115,"journal":{"name":"Brazilian Journal of Analytical Chemistry","volume":null,"pages":null},"PeriodicalIF":1.1000,"publicationDate":"2023-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Design of Experiments (DoE) Application in Two Cases of Study in Pharmaceutical Industries\",\"authors\":\"Romero Souza, Luiz Bonamichi, Edenir Pereira-Filho\",\"doi\":\"10.30744/brjac.2179-3425.ar-56-2023\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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.\",\"PeriodicalId\":9115,\"journal\":{\"name\":\"Brazilian Journal of Analytical Chemistry\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":1.1000,\"publicationDate\":\"2023-10-17\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Brazilian Journal of Analytical Chemistry\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.30744/brjac.2179-3425.ar-56-2023\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"CHEMISTRY, ANALYTICAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Brazilian Journal of Analytical Chemistry","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.30744/brjac.2179-3425.ar-56-2023","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CHEMISTRY, ANALYTICAL","Score":null,"Total":0}
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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