A Quality-by-Design (QbD) approach to development requires understanding the "design space". This is the quantified range of formulation and process inputs that will still yield product with the desired Critical Quality Attributes (CQAs). Both in vitro and in vivo drug release are key CQAs for the performance of dosage forms, hence it is important to understand how they are affected by process input variability. We invite submissions detailing methods and case studies on formulation, process development, and manufacturing approaches which affect the assay, dissolution, and clinical performance of immediate release and modified release dosage forms for various delivery routes (oral, parenteral, transdermal, etc.). Experimental studies, statistical approaches, and theoretical models are all welcome.

Topical I: Comprehensive Quality by Design in Pharmaceutical Development and Manufacture