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

• 영문명: Application of Open Source Based DoE R Program for the Development of QbD
• 발행기관: 대한약학회
• 저자명: 이종혁(JongHyuk Lee) 김주은(Joo-Eun Kim)
• 간행물 정보: 『약학회지』제63권 제5호(2019년), 274~281쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2019.10.30

영문 초록

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.

목차

서 론 (Introduction)

실험방법(Experimental Methods)

결과 및 고찰(Results and Discuss

결 론(Conclusion)

키워드

Quality by Design (QbD) Design of Experiments (DoE) open source R program statistics telmisartan potassium design space