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)