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Physiologically Based Biopharmaceutics Models (PBBM) were explored for drug product quality, focusing on regulatory and industry best practices. Case studies demonstrated PBBM applications in defining specifications and ensuring bioequivalence.

Keywords:
BioequivalenceIVIVCIVIVRPBBMbioequivalence safe spacecontext of usedissolutiondrug product qualitymodel credibility assessment frameworkmodeling

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Area of Science:

  • Pharmacokinetics and Drug Metabolism
  • Pharmaceutical Sciences
  • Regulatory Science

Background:

  • The workshop focused on Physiologically Based Biopharmaceutics Models (PBBM) best practices for drug product quality.
  • Day 2 specifically addressed regulatory and industry perspectives on PBBM application.

Purpose of the Study:

  • To provide proceedings from the 30th August 2023 workshop on PBBM.
  • To share case studies and learnings on PBBM verification, validation, and application.
  • To discuss current trends and barriers in PBBM implementation.

Main Methods:

  • Review of PBBM case studies from six regulatory authorities.
  • Discussion of credibility assessment frameworks, context of use (COU), and model risk assessment.
  • Breakout sessions addressing PBBM validation, disposition parameters, virtual bioequivalence trials, and acceptance criteria.

Main Results:

  • Case studies demonstrated PBBM use for defining critical material attributes (CMAs) like particle size distributions (PSDs).
  • PBBM applications for defining critical quality attributes (CQAs), dissolution specifications, and bioequivalence safe spaces were presented.
  • Learnings from case studies and breakout sessions identified key considerations for PBBM implementation.

Conclusions:

  • PBBMs offer valuable tools for drug product quality assessment, from material attributes to bioequivalence.
  • Effective application requires robust verification, validation, and clear context of use.
  • Addressing barriers related to credibility, data availability, and virtual trial execution is crucial for wider adoption.