Best Practices in Physiologically Based Pharmacokinetic (PBPK) Modeling
While physiologically based pharmacokinetic (PBPK) modeling has become a mechanistic cornerstone of model-informed drug development, recent reviews by the EMA and other regulatory bodies show that a significant disparity in quality persists. Too often, submitted models are not deemed adequately qualified for their intended context of use.
How do we bridge this gap in quality between regulatory expectations and submitted PBPK analyses?
Published in CPT: Pharmacometrics & Systems Pharmacology (#PSP), this collaborative new paper establishes a harmonized framework designed to improve the consistency, quality, and transparency of PBPK analyses, ultimately building greater regulatory confidence.
Key highlights:
- Comprehensive best practices: Actionable guidance spanning the entire PBPK workflow, including planning, data compilation, model development, evaluation, and application.
- Regulatory alignment: Direct harmonization of PBPK terminology and expectations with the ICH M15 guideline on MIDD.
- Fit-for-purpose strategy: Practical framework to define explicit technical criteria, ensuring models are demonstrably qualified for their specific Context of Use (CoU).
This paper represents a truly collaborative effort across the industry, bringing together experts with a common goal to establish harmonized best practices: Marylore Chenel and Erik Sjögren from Pharmetheus, in collaboration with Andre Dallmann and Michaela Meyer from Bayer, Ibrahim Ince from Boehringer Ingelheim, Jan Schlender from Novartis and Donato Teutonico from Sanofi.
