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Application of Open Source Based DoE R Program for the Development of QbD
Yakhak Hoeji 2019;63(5):274-281
Published online October 31, 2019
© 2019 The Pharmaceutical Society of Korea.

JongHyuk Lee and Joo-Eun Kim*,#

Department of Big Data Engineering, Catholic University of Daegu
*Department of Pharmaceutical Engineering, Catholic University of Daegu
Correspondence to: Joo-Eun Kim, Dept. of Pharmaceutical Engineering, Catholic University of Daegu, Gyeongbuk, 34840, Republic of Korea
Tel: +82-53-850-2561, Fax: +82-53-359-6726 E-mail: 77jooeun@naver.com
Received August 9, 2019; Revised September 4, 2019; Accepted September 23, 2019.
Abstract
To develop Quality by Design based drug, we compared and evaluated the self-made open source based DoE R program and the Minitab® statistic program, which are used in the Design of Experiments for reasonable experiments and data reliability. An open source based DoE R program for real-time data accumulation was developed to enable a design of experiment. Then, the independent variables and dependent variables in the wet granulation process of telmisartan potassium tablets were performed by experimental design using two DoE programs. After two statistical programs were executed, the regression equations, analysis of variance, model optimization, main effects plots, contour plots, response surface curves, and, design space were compared and analyzed with self-made DoE R program and a commercial statistic Minitab® program. As a result, it was confirmed that there were no significant differences in the slope, graph shape, P-values, and plot patterns between the two DoE programs.
Keywords : Quality by Design (QbD), Design of Experiments (DoE), open source, R program, statistics, telmisartan potassium, design space


October 2019, 63 (5)
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