This project has been archived.
PBPK Modeling White Paper Working Group (Author & Review Teams)
General Opportunities for Successful & Impactful Application in Drug Development
• Increase in knowledge of the system (e.g. enzymes and transporters)
• Increased collaboration to advance capabilities (e.g. Orbito consortium on absorption)
• Rapidly improving software tools requires increasing level of expertise among preclinical, clinical & modeling & simulation
• PBPK modeling facilitates collaborative working within companies to deliver impactful decisions & optimize drug development
• PBPK modeling supports effective regulatory interactions
Milestones (information current as of April 2015)
• March 10, 2014 - FDA Public Workshop : “Application of Physiologically-Based Pharmacokinetic Modeling To Support Dose Selection”
• June 30, 2014 - ABPI and MHRA : “MISG New Technologies Forum on physiologically based pharmacokinetic (PBPK) modelling and simulation”
• November 14, 2014 - IQ White paper accepted for publication. Published as:
Jones, H. M. et al. (2015). "Physiologically based pharmacokinetic modeling in drug discovery and development: A pharmaceutical industry perspective." Clinical pharmacology & Therapeutics 97(3): 247-262.