Robust design with time-oriented responses for regenerative medicine industry

In regenerative medicine industry, one of the key problems is to reduce variation of output characteristics so that a generic drug can pass the statistical criteria for bioequivalence tests. Quality by design (QbD) is a set of offline tools in which robust design (RD) plays significant role in controlling variance in the pharmaceutical process recently. The conventional RD approach basically deals with static data while the bioequivalence tests require dynamic (time-oriented) data. The primary objective of this paper is to develop a new RD approach with time-oriented responses to bioequivalence tests for generic drug. Because the responses are a function of control factors and time, it is reasonable that the tentative relationship can be analyzed according to both vertical and horizontal directions in which the response surface methodology (RSM) is utilized. For seeking the optimal control factors setting, a mean squared error (MSE) robust design model is chosen and optimized by utilizing Matlab package. A experimental study is conducted to demonstrate how to apply proposed RD approach in practice and how can it be used to improve the quality of generic drug for meeting statistical criteria of bioequivalence tests.