TY  - JOUR
A1  - McAllister, Mark
A1  - Flanagan, Talia
A1  - Cole, Susan
A1  - Abend, Andreas
A1  - Kotzagiorgis, Evangelos
A1  - Limberg, Jobst
A1  - Mead, Heather
A1  - Mangas Sanjuan, Victor
A1  - Dickinson, Paul A.
A1  - Moir, Andrea
A1  - Pepin, Xavier
A1  - Zhou, Diansong
A1  - Tistaert, Christophe
A1  - Dokoumetzidis, Aristides
A1  - Anand, Om
A1  - Le Merdy, Maxime
A1  - Turner, David B.
A1  - Griffin, Brendan T.
A1  - Darwich, Adam
A1  - Dressman, Jennifer B.
A1  - Mackie, Claire
T1  - Developing clinically relevant dissolution specifications (CRDSs) for oral drug products: virtual webinar series
T2  - Pharmaceutics
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.
KW  - oral drug products
KW  - clinically relevant dissolution specifications
KW  - PBBM
KW  - product performance
KW  - biorelevant dissolution
Y1  - 2022
UR  - http://publikationen.ub.uni-frankfurt.de/frontdoor/index/index/docId/71894
UR  - https://nbn-resolving.org/urn:nbn:de:hebis:30:3-718949
SN  - 1999-4923
VL  - 14
IS  - 5, art. 1010
SP  - 1
EP  - 26
PB  - Molecular Diversity Preservation International
CY  - Basel
ER  -