Introduction

A 2-day workshop entitled “In Vivo Predictive Dissolution and Simulation” was held September 11–12, 2017 in Washington, DC, focused on the selection of applications, methodologies, and scientific advancements to predict in vivo bioperformance of oral drug products/oral drug formulations based on the active pharmaceutical ingredient (API) and drug product formulation. This workshop was fully sponsored by the AAPS and featured speakers from industry, academia, and regulatory agencies to introduce the state-of-the-art in cutting-edge applications, methodologies, and latest initiatives in in vivo prediction of oral drug product performance to attendees worldwide. A broad range of dissolution methodologies and simulations together with the determination of developability based on physicochemical characteristics were discussed, with specific considerations for in vivo prediction implementing bioavailability (BA), bioequivalence (BE), and quality by design (QbD), in this 2-day…