Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Brazilian Journal of Pharmaceutical Sciences |
Texto Completo: | https://www.revistas.usp.br/bjps/article/view/153905 |
Resumo: | According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many input factors that may affect quality of product and methods. Recently, Design of Experiments (DoE) have been widely used to understand the effects of multidimensional and interactions of input factors on the output responses of pharmaceutical products and analytical methods. This paper provides theoretical and practical considerations for implementation of Design of Experiments (DoE) in pharmaceutical and/or analytical Quality by Design (QbD). This review illustrates the principles and applications of the most common screening designs, such as two-level full factorial, fractionate factorial, and Plackett-Burman designs; and optimization designs, such as three-level full factorial, central composite designs (CCD), and Box-Behnken designs. In addition, the main aspects related to multiple regression model adjustment were discussed, including the analysis of variance (ANOVA), regression significance, residuals analysis, determination coefficients (R2 , R2 -adj, and R2 -pred), and lack-of-fit of regression model. Therefore, DoE was presented in detail since it is the main component of pharmaceutical and analytical QbD. |
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Brazilian Journal of Pharmaceutical Sciences |
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Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)Design of Experiments (DoE)Quality by Design (QbD)Factorial DesignsCentral Composite Designs (CCD)Box-Behnken DesignsResponse Surface Methodology (RSM)According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many input factors that may affect quality of product and methods. Recently, Design of Experiments (DoE) have been widely used to understand the effects of multidimensional and interactions of input factors on the output responses of pharmaceutical products and analytical methods. This paper provides theoretical and practical considerations for implementation of Design of Experiments (DoE) in pharmaceutical and/or analytical Quality by Design (QbD). This review illustrates the principles and applications of the most common screening designs, such as two-level full factorial, fractionate factorial, and Plackett-Burman designs; and optimization designs, such as three-level full factorial, central composite designs (CCD), and Box-Behnken designs. In addition, the main aspects related to multiple regression model adjustment were discussed, including the analysis of variance (ANOVA), regression significance, residuals analysis, determination coefficients (R2 , R2 -adj, and R2 -pred), and lack-of-fit of regression model. Therefore, DoE was presented in detail since it is the main component of pharmaceutical and analytical QbD.Universidade de São Paulo. Faculdade de Ciências Farmacêuticas2018-12-28info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/bjps/article/view/15390510.1590/s2175-97902018000001006Brazilian Journal of Pharmaceutical Sciences; Vol. 54 Núm. Especial (2018); e01006Brazilian Journal of Pharmaceutical Sciences; v. 54 n. Especial (2018); e01006Brazilian Journal of Pharmaceutical Sciences; Vol. 54 No. Especial (2018); e010062175-97901984-8250reponame:Brazilian Journal of Pharmaceutical Sciencesinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/bjps/article/view/153905/150235Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso)info:eu-repo/semantics/openAccessFukuda, Isa MartinsPinto, Camila Francini FidelisMoreira, Camila dos SantosSaviano, Alessandro MoraisLourenço, Felipe Rebello2019-03-17T12:31:44Zoai:revistas.usp.br:article/153905Revistahttps://www.revistas.usp.br/bjps/indexPUBhttps://old.scielo.br/oai/scielo-oai.phpbjps@usp.br||elizabeth.igne@gmail.com2175-97901984-8250opendoar:2019-03-17T12:31:44Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP)false |
dc.title.none.fl_str_mv |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) |
title |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) |
spellingShingle |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) Fukuda, Isa Martins Design of Experiments (DoE) Quality by Design (QbD) Factorial Designs Central Composite Designs (CCD) Box-Behnken Designs Response Surface Methodology (RSM) |
title_short |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) |
title_full |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) |
title_fullStr |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) |
title_full_unstemmed |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) |
title_sort |
Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD) |
author |
Fukuda, Isa Martins |
author_facet |
Fukuda, Isa Martins Pinto, Camila Francini Fidelis Moreira, Camila dos Santos Saviano, Alessandro Morais Lourenço, Felipe Rebello |
author_role |
author |
author2 |
Pinto, Camila Francini Fidelis Moreira, Camila dos Santos Saviano, Alessandro Morais Lourenço, Felipe Rebello |
author2_role |
author author author author |
dc.contributor.author.fl_str_mv |
Fukuda, Isa Martins Pinto, Camila Francini Fidelis Moreira, Camila dos Santos Saviano, Alessandro Morais Lourenço, Felipe Rebello |
dc.subject.por.fl_str_mv |
Design of Experiments (DoE) Quality by Design (QbD) Factorial Designs Central Composite Designs (CCD) Box-Behnken Designs Response Surface Methodology (RSM) |
topic |
Design of Experiments (DoE) Quality by Design (QbD) Factorial Designs Central Composite Designs (CCD) Box-Behnken Designs Response Surface Methodology (RSM) |
description |
According to Quality by Design (QbD) concept, quality should be built into product/method during pharmaceutical/analytical development. Usually, there are many input factors that may affect quality of product and methods. Recently, Design of Experiments (DoE) have been widely used to understand the effects of multidimensional and interactions of input factors on the output responses of pharmaceutical products and analytical methods. This paper provides theoretical and practical considerations for implementation of Design of Experiments (DoE) in pharmaceutical and/or analytical Quality by Design (QbD). This review illustrates the principles and applications of the most common screening designs, such as two-level full factorial, fractionate factorial, and Plackett-Burman designs; and optimization designs, such as three-level full factorial, central composite designs (CCD), and Box-Behnken designs. In addition, the main aspects related to multiple regression model adjustment were discussed, including the analysis of variance (ANOVA), regression significance, residuals analysis, determination coefficients (R2 , R2 -adj, and R2 -pred), and lack-of-fit of regression model. Therefore, DoE was presented in detail since it is the main component of pharmaceutical and analytical QbD. |
publishDate |
2018 |
dc.date.none.fl_str_mv |
2018-12-28 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/153905 10.1590/s2175-97902018000001006 |
url |
https://www.revistas.usp.br/bjps/article/view/153905 |
identifier_str_mv |
10.1590/s2175-97902018000001006 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
dc.relation.none.fl_str_mv |
https://www.revistas.usp.br/bjps/article/view/153905/150235 |
dc.rights.driver.fl_str_mv |
Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso) info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
Copyright (c) 2018 Brazilian Journal of Pharmaceutical Sciences (Impresso) |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf |
dc.publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
publisher.none.fl_str_mv |
Universidade de São Paulo. Faculdade de Ciências Farmacêuticas |
dc.source.none.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences; Vol. 54 Núm. Especial (2018); e01006 Brazilian Journal of Pharmaceutical Sciences; v. 54 n. Especial (2018); e01006 Brazilian Journal of Pharmaceutical Sciences; Vol. 54 No. Especial (2018); e01006 2175-9790 1984-8250 reponame:Brazilian Journal of Pharmaceutical Sciences instname:Universidade de São Paulo (USP) instacron:USP |
instname_str |
Universidade de São Paulo (USP) |
instacron_str |
USP |
institution |
USP |
reponame_str |
Brazilian Journal of Pharmaceutical Sciences |
collection |
Brazilian Journal of Pharmaceutical Sciences |
repository.name.fl_str_mv |
Brazilian Journal of Pharmaceutical Sciences - Universidade de São Paulo (USP) |
repository.mail.fl_str_mv |
bjps@usp.br||elizabeth.igne@gmail.com |
_version_ |
1800222913838710784 |