TY - JOUR
T1 - Developing Clinically Relevant Dissolution Specifications (CRDSs) for Oral Drug Products
T2 - Virtual Webinar Series
AU - McAllister, Mark
AU - Flanagan, Talia
AU - Cole, Susan
AU - Abend, Andreas
AU - Kotzagiorgis, Evangelos
AU - Limberg, Jobst
AU - Mead, Heather
AU - Mangas-Sanjuan, Victor
AU - Dickinson, Paul A.
AU - Moir, Andrea
AU - Pepin, Xavier
AU - Zhou, Diansong
AU - Tistaert, Christophe
AU - Dokoumetzidis, Aristides
AU - Anand, Om
AU - Le Merdy, Maxime
AU - Turner, David B.
AU - Griffin, Brendan T.
AU - Darwich, Adam
AU - Dressman, Jennifer
AU - Mackie, Claire
N1 - Publisher Copyright:
© 2022 by the authors. Licensee MDPI, Basel, Switzerland.
PY - 2022/5
Y1 - 2022/5
N2 - 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.
AB - 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.
KW - biorelevant dissolution
KW - clinically relevant dissolution specifications
KW - oral drug products
KW - PBBM
KW - product performance
UR - https://www.scopus.com/pages/publications/85130127779
U2 - 10.3390/pharmaceutics14051010
DO - 10.3390/pharmaceutics14051010
M3 - Article
AN - SCOPUS:85130127779
SN - 1999-4923
VL - 14
JO - Pharmaceutics
JF - Pharmaceutics
IS - 5
M1 - 1010
ER -