Design of Experiments in Pharmaceutical Development

Dhoot, Abhishek Sunil and Fernandes, Gasper Joseph and Naha, Anup and Rathnanand, Mahalaxmi and Kumar, Lalit (2019) Design of Experiments in Pharmaceutical Development. Pharmaceutical Chemistry Journal, 58 (8). pp. 730-735. ISSN 0091-150X

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Abstract

In order to develop high-quality pharmaceutical products, a traditional approach based the univariate or trial and error method was used in the past that led to several problems like non-reproducible, high-cost, and time consuming methods. To overcome these drawbacks, a new concept of the Design of Experiment (DoE) was introduced. DoE is a statistical element of the Quality by Design (QbD) approach introduced by British statistician Sir Ronald Fisher in 1925. The basic objectives of DoE are screening, optimization, and robustness. It involves the execution of experimental design on the basis of suitable variables along with statistical evaluation of obtained responses and exploration of the design space using mathematical or graphical approach. The statistical evaluation empowers to build up the quality of finished products and helps to meet the increasing demands for product of superior quality and standards. This article mainly focuses on the applications of DoE in pharmaceutical product development along with its objectives, design, and selection criteria

Item Type: Article
Uncontrolled Keywords: Design of Experiment (DoE); Quality by Design (QbD); Design; Pharmaceutical product development
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutics
Depositing User: KMC Library
Date Deposited: 12 Feb 2020 05:45
Last Modified: 12 Feb 2020 05:45
URI: http://eprints.manipal.edu/id/eprint/154910

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