A 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, has recently been published in the Journal of Pharmaceutical Sciences.
The article is a summary of the output from day 3 of the workshop titled “Current State and Future Expectations of Translational Modelling 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 theme of day 3 was practical applications of Physiologically based biopharmaceutics modelling to support drug product quality. The workshop and its output will be influential in the future uptake of PBBM / PBPK for absorption modelling.
Each day of the workshop had a dedicated theme: Day 1: challenges and gaps in the biopredictive in vitro biopharmaceutics tools needed to support PBBM (e.g., biopredictive dissolution methods). Day 2: best practices in PBBM development, verification and validation. Day 3: PBBM case studies from FDA, EMA and industry. Four papers in total were published in relation to this workshop, links to which 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
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