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Experimental results pertaining to natural pharmaceutical complex products (NPCPs) often exhibit large variabilities in their associated response variables. To improve the quality of an NPCP, systemic studies (i.e., statistical analysis and mathematical optimization), including variability analysis and robust optimization, are often required. To this end, a systemic approach for an NPCP development process is proposed by integrating robust design and optimization methodologies. A quality function deployment method can be used to systematically define a standardized manufacturing process and relevant process variables for Chong Kun Dang (CKD)-497. Based on those variables, an experiment is designed using response surface methodology to mathematically estimate the output response functions associated with input variables. In addition, a design space (DS), which can guarantee the quality of an NPCP, is demonstrated by utilizing the overlaid contour plots of the estimated response functions. Finally, a CKD-497 case study is conducted for verification and validation.

Robust Optimization Approaches for a Natural Pharmaceutical Complex Product of Atractylodes Japonica Koidz and Schisandra Chinensis