Mechanistic Absorption/PBPK Modeling to Predict Positive/Negative Food Effects: Approaches and Special Considerations

Authors: DiBella J
Conference: Le Club Phase 1 PBPK Symposium
Keywords: fasted, fed, Food effects, MAM, PBPK, physiologically based pharmacokinetics (PBPK)
Software: ADMET Predictor®, GastroPlus®, MembranePlus™
Division: PBPK

Outline

  • Early examples and proposed approach
  • Fasted vs. fed state model descriptions – where are we today?
  • Case study: positive food effect predictions – input review
  • Case study: negative food effect predictions – in vitro considerations
  • Future directions and conclusions

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

By John DiBella