Leveraging PopPK and PBPK Modeling Approaches to Understand Food/PPI Effects

Authors: DiBella J
Conference: Le Club Phase 1 PBPK Symposium
Keywords: ACAT model, drug-drug interactions (DDIs), food, mechanistic absorption model, PBPK, pbpk symposium, physiologically based pharmacokinetics, PopPK, population pharmacokinetics, PPI, proton pump inhibitor
Division: Simulations Plus
  • Applying both top-down (PopPK and PBPK) and bottom-up (PBPK) modeling approaches can leverage existing data sets and help prospectively answer questions
  • Predictions of absorption-related DDIs requires clinical data and close evaluation of the physiological environment
    • Deconvoluting gastric emptying/pH changes vs. time provides clues
    • Population PBPK simulations which implement variability in gastric physiology can best capture expected range of PK endpoints
  • Continued collaborations between departments and modeling groups will lead to:
    • Increased confidence in the direction/recommendations of a program
    • Improved opportunities to engage with regulatory agencies on proposed strategies

Le Club Phase 1 PBPK Symposium 2018, April 4th, 2018, Paris, France

By John Dibella