Example unit operations are drawn from the published literature, which include both journal papers and patents from various academic and industrial research groups. The presentation will also review and comment on the application of Quality-by-Design methodologies to pharmaceutical manufacturing. Of particular interest is the generation of design spaces, and the pros and cons of different approaches. In particular, it is shown that many of the methods for the construction of design spaces that have been proposed in the literature are useless from a control or operations point of view.
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