Integrating Inverse problem to robust design for a generic drug development process

Robust design (RD) has emerged as a key feature in process design and development for more than twenty years. Many researchers and industrial engineers around the world have invested their intensive efforts to develop and apply RD in many fields in order to improve quality of output products. However, there is also room for improvement. The primary objective of this research is to determine "robust formulation" of a medicine by checking its gelation index. In order to achieve this target, based on the nature of problem, at first, a customized experimental format is designed for obtaining data. Second, time-depended responses based models are developed by the proposed inverse problem (IP) methodology. Third, an RD model based on mean square error (MSE) concept is introduced for time-depended responses. Finally, the proposed approach is illustrated by a case study while comparing obtained results to the response surface methodology (RSM) approach.

역산문제 방법을 적용한 제네릭 의약품 개발 프로세스의 강건 설계