AAPS Workshop on Developing a Biopharmaceutics Risk Assessment Road Map

Patient-centric drug development requires robust and transparent linkages between patient needs (therapeutic indication with optimized drug delivery patterns), and the key drug product attributes as captured in the Quality Target Product Profile. Specifically, one seeks to build a relationship between in vitro and in vivo performance in order to achieve the desired delivery pattern consistent with the intended therapeutic outcome. The biopharmaceutics risk assessment road map will facilitate connections (from patient needs to the drug product) and provide information on "what's needed and how."