New publication co-authored by Paul Dickinson addressing the criticality of Biopharmaceutics modelling (i.e. PBBM) in the development of clinically relevant drug product specifications.
The article is a summary of the output from day 3 of the workshop titled“ Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls”, attended by an invited group of representatives from global healthcare regulatory agencies and thought leaders from across the pharmaceutical industry. The workshop and its output will be influential in the future uptake of PBBM / PBPK for absorption modelling.
Links to the 4 papers published in relation to this workshop are provided below.
https://www.sciencedirect.com/science/article/abs/pii/S0022354920302446 https://www.jpharmsci.org/article/S0022-3549(20)30549-9/fulltext https://www.sciencedirect.com/science/article/abs/pii/S0022354920306080 https://www.jpharmsci.org/article/S0022-3549(20)30679-1/fulltext