Latest thinking on mechanistic approach to QbD and Design Space

Notes of the presentation by our team to FDA CDER (28 February 2008) on the role of mechanistic thinking and modeling in Design Space and QbD are now available to download from http://www.scale-up.com/usersarea (site membership and login required) Among other topics, these address questions posed by the industry about usage of models alongside statistical design of experiments and model verification requirements for submissions.