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Physiologically based pharmacokinetic (PBPK) modelling tools: how to fit with our needs?
François Bouzom1, Kathryn Ball, Nathalie Perdaems
1Technologie Servier, 25/27 Rue E. Vignat, 45000, Orleans, France. francois.bouzom@fr.netgrs.com
Biopharmaceutics & Drug Disposition
|January 10, 2012
Summary
Physiologically based pharmacokinetic (PBPK) software has advanced significantly, enabling sophisticated whole-body PBPK modeling. Training scientists on PBPK assumptions and in vitro-to-in vivo extrapolation (IVIVE) is crucial for its effective use in drug development.
Area of Science:
- Pharmacology
- Computational Biology
- Drug Development
Background:
- Commercial Physiologically Based Pharmacokinetic (PBPK) software has evolved considerably since 2005.
- Advancements allow for sophisticated whole-body PBPK (WB-PBPK) modeling, integrating ADME processes.
Purpose of the Study:
- To compare features, benefits, and limitations of 'ready-to-use' versus user-customizable PBPK software.
- To discuss challenges and future directions for PBPK modeling approaches.
Main Methods:
- Review and comparison of available commercial PBPK software.
- Analysis of PBPK modeling approaches in drug development.
Main Results:
- 'Ready-to-use' PBPK software has increased PBPK modeling adoption in the pharmaceutical industry.
- PBPK models offer a quantitative, physiologically realistic platform for pharmacokinetic and pharmacodynamic predictions.
Conclusions:
- Effective utilization of PBPK models requires comprehensive training for scientists and modelers.
- Understanding the assumptions and limitations of the 'virtual body' framework and IVIVE is essential for accurate predictions.
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