Parameterization of Physiologically Based Biopharmaceutics Models: Workshop Summary Report

Area of Science:

• Pharmacokinetics and Drug Metabolism
• Pharmaceutical Sciences
• Computational Chemistry

Background:

• Physiologically Based Biopharmaceutics Modeling (PBBM) is crucial for assessing drug product quality.
• Regulatory agencies and industry experts convened to discuss PBBM best practices.
• Model parameterization remains a key challenge in PBBM applications.

Purpose of the Study:

• To share proceedings from a workshop on PBBM best practices for drug product quality.
• To present regulatory perspectives on PBBM case studies and submission requirements.
• To identify and discuss best practices for PBBM parameterization.

Main Methods:

• Compilation of presentations and discussions from a workshop on PBBM.
• Review of regulatory authority feedback on industry-submitted PBBM case studies.
• Exploration of key scientific questions in PBBM parameterization through breakout sessions.

Main Results:

• Regulatory authorities shared key questions and assessment processes for PBBM submissions.
• Best practices for integrating drug solubility, excipient effects, and dissolution were discussed.
• Methods for modeling drug precipitation and permeability for PBBM were explored.

Conclusions:

• Standardized best practices for PBBM parameterization are essential for regulatory acceptance.
• Improved integration of in vitro data and mechanistic modeling enhances in vivo performance predictions.
• Collaboration between industry and regulators is vital for advancing PBBM applications in drug development.