(48b) QbD - It's Not Just for Breakfast Anymore

Collins, P. C. - Presenter, Eli Lilly and Co

We are approaching the ten-year mark for the Quality by Design initiative in the pharmaceutical industry.  Much has been accomplished and demonstrated, particularly with regard to enhanced understanding of processes and better definition of processing parameters such as CPPs.  Design space has become an often utilized term when process scientists talk about their projects and the concept has led to increased use of modeling approaches in late stage development.   Despite the interest generated by the initiative and the progress made by it's participants, the true power of QbD may yet to be unleashed.  Human-centered design of pharmaceuticals, with a more intimate tie to patient need and patient performance, should be the next step in how we more forward the QbD initiative, and represents a new way for engineers to influence drug design.