Data required to build a fit-for-purpose PBPK model: How much is necessary?

Authors: Ketkar AR
Conference: DISSO
Keywords: biopredictive dissolution, modeling and simulation, PBPK modeling, physiological based biopharmaceutics models (PBBM)
Software: ADMET Predictor®, DDDPlus™, GastroPlus®, MembranePlus™
Division: PBPK

PBPK M&S and PBBM

  • PBPK Modeling: Physiologically Based Pharmacokinetic Modelling
    • A mathematical modelling technique for predicting the ADME of synthetic or natural chemical substances in humans and other animal species
  • PBBM: Physiologically Based Biopharmaceutics Modelling
    • Establishing the link between bio-predictive in vitro dissolution testing and mechanistic oral absorption modeling
    • Mechanistic implementation of formulation/manufacturing aspects that are relevant to dissolution/release from the drug product
    • Verifying whether the dissolution method of the pharmaceutical product is bio-predictive or clinically relevant

By Anant Kektar

Presented at DISSO India June 23-25, 2022