AN UPDATED REVIEW ON DESIGN OF EXPERIMENT (DOE) IN PHARMACEUTICALS

  • Gaurav Gujral Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan, India
  • Devesh Kapoor Dr. Dayaram Patel Pharmacy College, Sardarbaug, Station Road, Bardoli, Dist – Surat, Gujarat, India, Pin-394601
  • Manish Jaimini Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

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)

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Author Biographies

Gaurav Gujral, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan, India

Research Scholar, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan, India

 

Devesh Kapoor, Dr. Dayaram Patel Pharmacy College, Sardarbaug, Station Road, Bardoli, Dist – Surat, Gujarat, India, Pin-394601

Dr. Dayaram Patel Pharmacy College, Sardarbaug, Station Road, Bardoli, Dist – Surat, Gujarat, India, Pin-394601

Manish Jaimini, Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

Department of Pharmacy, Maharishi Arvind University, Jaipur, Rajasthan

References

1. Design of experiments (DoE) in pharmaceutical development, Drug Dev Ind Pharm. 2017 Jun; 43(6):889-901.
2. 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
3. The Design of Optimal Multifactorial Experiments" in Biometrika (vol. 33).
4. Support.minitab.com
5. Shivare M, Mc Creath G, Practical consideration for DOE Implementation in Quality by design, Bioprocess, Technical, 2010.
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How to Cite
1.
Gujral G, Kapoor D, Jaimini M. AN UPDATED REVIEW ON DESIGN OF EXPERIMENT (DOE) IN PHARMACEUTICALS. JDDT [Internet]. 14May2018 [cited 5Aug.2021];8(3):147-52. Available from: https://jddtonline.info/index.php/jddt/article/view/1713