설계기반품질고도화(QbD)의약품 개발을 위한 오픈소스 기반 실험설계 R 프로그램의 활용

To develop Quality by Design based drug, we compared and evaluated the self-made open source based DoER program and the Minitab® statistic program, which are used in the Design of Experiments for reasonable experimentsand data reliability. An open source based DoE R program for real-time data accumulation was developed to enable adesign of experiment. Then, the independent variables and dependent variables in the wet granulation process of telmisartanpotassium tablets were performed by experimental design using two DoE programs. After two statistical programs wereexecuted, the regression equations, analysis of variance, model optimization, main effects plots, contour plots, responsesurface curves, and, design space were compared and analyzed with self-made DoE R program and a commercial statisticMinitab® program. As a result, it was confirmed that there were no significant differences in the slope, graph shape, Pvalues,and plot patterns between the two DoE programs. KCI Citation Count: 0