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

Application of Open Source Based DoE R Program for the Development of QbD

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, Pvalues, and plot patterns between the two DoE programs.