Response surface methodology (RSM) has been widely recognized as an essential estimation tool in many robust design studies investigating the second-order polynomial functional relationship between the responses of interest and their associated input variables. However, there is scope for improvement in the flexibility of estimation models and the accuracy of their results. Although many NN-based estimations and optimization approaches have been reported in the literature, a closed functional form is not readily available. To address this limitation, a maximum-likelihood estimation approach for an NN-based response function estimation (NRFE) is used to obtain the functional forms of the process mean and standard deviation. While the estimation results of most existing NN-based approaches depend primarily on their transfer functions, this approach often requires a screening procedure for various transfer functions. In this study, the proposed NRFE identifies a new screening procedure to obtain the best transfer function in an NN structure using a desirability function family while determining its associated weight parameters. A statistical simulation was performed to evaluate the efficiency of the proposed NRFE method. In this particular simulation, the proposed NRFE method provided significantly better results than conventional RSM. Finally, a numerical example is used for validating the proposed method.

In robust design (RD) modeling, the response surface methodology (RSM) based on the least-squares method (LSM) is a useful statistical tool for estimating functional relationships between input factors and their associated output responses. Neural network (NN)-based models provide an alternative means of executing input-output functions without the assumptions necessary with LSM-based RSM. However, current NN-based estimation methods do not always provide suitable response functions. Thus, there is room for improvement in the realm of RD modeling. In this study, a new NN-based RD modeling procedure is proposed to obtain the process mean and standard deviation response functions. Second, RD modeling methods based on the feed-forward back-propagation neural network (FFNN), cascade-forward back-propagation neural network (CFNN), and radial basis function network (RBFN) are proposed. Third, two simulation studies are conducted using a given true function to verify the proposed three methods. Fourth, a case study is examined to illustrate the potential of the proposed approach. In conclusion, a comparative analysis of the three feed-forward NN structure-based modeling methods and conventional LSM-based RSM proposed in this study showed that the proposed methods were significantly lower in the expected quality loss (EQL) and various variability indicators.

A number of pharmaceutical quality characteristics are destructive or too costly to inspect. However, most quality improvement tools developed in the pharmaceutical research community typically assume that quality characteristics are nondestructive. This paper proposes a new design system for quality improvement by incorporating the concept of surrogate variables with the concepts of robust design (RD) and tolerance design (TD). The proposed robust-tolerance design paradigm determines the optimal factor setting and specification limits simultaneously, thereby improving quality of pharmaceutical products. In addition, the proposed methodology can provide the optimal tolerance as a mathematical closed-form solution. Finally, a numerical example and its associated sensitivity analysis for a pharmaceutical case are conducted for verification purposes. Based on the numerical example results, the proposed approach could provide robust factor settings with significant tradeoffs between quality and cost.