A PBPK analysis uses models and simulations that combine physiology, population and drug characteristics to mechanistically describe the pharmacokinetic (PK) behavior of a drug. Throughout a drug’s life cycle, PBPK model predictions can be used to support decisions on whether, when and how to conduct certain clinical pharmacology studies and to support dosing recommendations in product labeling.
Use PBPK Modeling for . . .
- Early phase development work (bioanalysis, formulation optimization, PK prediction)
- Dose regimen design and optimization
- Interspecies scaling/Phase I FIH exposure predictions
- Population factors (age, ethnicity, gene expression, etc.)
- Formulation bridging/bioequivalence
- Prediction of drug-drug interaction
- Antibody PBPK to understand target coverage