AN UPDATED REVIEW ON DESIGN OF EXPERIMENT (DOE) IN PHARMACEUTICALS
Abstract
DoE is a structured, organized method for determining the relationships among factors affecting a process and its output.It has been suggested that DoE can offer returns that are four to eight times greater than the cost of running the experiments in a fraction of the time that it would take to run one-factor-at-a-time experiments.It is always important before beginning experimentation to determine the objective of an experiment, and this is no different with DoE. Identifying objectives helps focus a team on its specific aims (scientific understanding of the task/problem in hand) over a period of time. It also helps indicate what resources are and assists in managing expectations from a study’s outcome. DoE studies in support of QbD are often a delicate balance between delivering defined, high-quality products and meeting predetermined time, labor, and financial constraints.
Keywords: Quality by design (QbD), Design of experiment (DoE), Process analytical technologies (PAT), One factor at a time (OFAT), Quality risk management (QRM), Critical process parameters (CPP), Analysis of variance (ANOVA)
DOI
https://doi.org/10.22270/jddt.v8i3.1713References
Design of experiments (DoE) in pharmaceutical development, Drug Dev Ind Pharm. 2017 Jun; 43(6):889-901.
Chowdary K.P.R., Ravi Shankar K., Optimization of pharmaceutical product formula-tion by factorial designs: case studies, Journal of pharmaceutical research, 2016; 15(4): 105-109
The Design of Optimal Multifactorial Experiments" in Biometrika (vol. 33).
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Shivare M, Mc Creath G, Practical consideration for DOE Implementation in Quality by design, Bioprocess, Technical, 2010.
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