QUALITY-BY-DESIGN – Quality-by-Design: The Good, The Bad, The Inevitable

To bring new ideas and innovations into the real world, science has to be made into something tangible. While that’s the fundamental mission for many pharmaceutical companies, that’s exactly where many drug development programs fall short – in the actual formulation, engineering, and production of new products. This is evident as the US Food and Drug Administration (FDA) continues to emphasize the “modernization of the regulation of pharmaceutical manufacturing and product quality.” Poised to be the key driver of that mission is Quality-by-Design (QbD).1

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