Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD)

  • Isa Martins Fukuda University of São Paulo. School of Pharmaceutical Sciences. Department of Pharmacy
  • Camila Francini Fidelis Pinto University of São Paulo. Faculty of Pharmaceutical Sciences. Department of Pharmacy
  • Camila dos Santos Moreira University of São Paulo. Faculty of Pharmaceutical Sciences. Department of Pharmacy
  • Alessandro Morais Saviano University of São Paulo. Faculty of Pharmaceutical Sciences. Department of Pharmacy
  • Felipe Rebello Lourenço University of São Paulo. Faculty of Pharmaceutical Sciences. Department of Pharmacy
Keywords: Design of Experiments (DoE), Quality by Design (QbD), Factorial Designs, Central Composite Designs (CCD), Box-Behnken Designs, Response Surface Methodology (RSM)

Abstract

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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Published
2018-12-28
How to Cite
Fukuda, I., Pinto, C., Moreira, C., Saviano, A., & Lourenço, F. (2018). Design of Experiments (DoE) applied to Pharmaceutical and Analytical Quality by Design (QbD). Brazilian Journal of Pharmaceutical Sciences, 54(Especial), e01006. https://doi.org/10.1590/s2175-97902018000001006
Section
Review