Researchers often identify robust design, based on the concept of building quality into products\r\nor processes, as one of the most important systems engineering design concepts for quality\r\nimprovement and process optimization. Traditional robust design principles have often been\r\napplied to situations in which the quality characteristics of interest are typically time-insensitive.\r\nIn pharmaceutical manufacturing processes, time-oriented quality characteristics, such as the\r\ndegradation of a drug, are often of interest. As a result, current robust design models for\r\nquality improvement which have been studied in the literature may not be effective in finding\r\nrobust design solutions. In this paper, we show how the robust design concepts can be applied\r\nto the pharmaceutical production research and development by proposing experimental and\r\noptimization models which should be able to handle the time-oriented characteristics. This is\r\nperhaps the first attempt in the robust design field. An example is given, and comparative studies\r\nare discussed for model verification.
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