Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report.

ABSTRACT: This Article shares the proceedings from the August 29th, 2023 (day 1) workshop "Physiologically Based Biopharmaceutics Modeling (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives". The focus of the day was on model parametrization; regulatory authorities from Canada, the USA, Sweden, Belgium, and Norway presented their views on PBBM case studies submitted by industry members of the IQ consortium. The presentations shared key questions raised by regulators during the mock exercise, regarding the PBBM input parameters and their justification. These presentations also shed light on the regulatory assessment processes, content, and format requirements for future PBBM regulatory submissions. In addition, the day 1 breakout presentations and discussions gave th

SUBMITTER: Pepin X 

PROVIDER: S-EPMC11304397 | biostudies-literature | 2024 Aug

REPOSITORIES: biostudies-literature