Abstract

A webinar series that was organised by the Academy of Pharmaceutical Sciences Biopharmaceutics focus group in 2021 focused on the challenges of developing clinically relevant dissolution specifications (CRDSs) for oral drug products. Industrial scientists, together with regulatory and academic scientists, came together through a series of six webinars, to discuss progress in the field, emerging trends, and areas for continued collaboration and harmonisation. Each webinar also hosted a Q&A session where participants could discuss the shared topic and information. Although it was clear from the presentations and Q&A sessions that we continue to make progress in the field of CRDSs and the utility/success of PBBM, there is also a need to continue the momentum and dialogue between the industry and regulators. Five key areas were identified which require further discussion and harmonisation.

By Mark McAllister, Talia Flanagan, Susan Cole, Andreas Abend, Evangelos Kotzagiorgis, Jobst Limberg, Heather Mead, Victor Mangas-Sanjuan, Paul A. Dickinson, Andrea Moir, Xavier Pepin, Diansong Zhou, Christophe Tistaert, Aristides Dokoumetzidis, Om Anand, Maxime Le Merdy, David B. Turner, Brendan T. Griffin, Adam Darwich, Jennifer Dressman and Claire Mackie