PBPK vs population PK
PBPK describes physiology and drug movement. Population PK estimates typical kinetics and variability from pooled observations.
PBPK describes physiology and drug movement. Population PK estimates typical kinetics and variability from pooled observations (FDA. Physiologically Based Pharmacokinetic Analyses: Format and Content. 2018., FDA. Population Pharmacokinetics. 2022.).
To predict the impact of a strong CYP3A inhibitor that was not tested clinically, a PBPK model may use information about the enzyme pathway and inhibitor. To estimate between-patient clearance variation from sparse clinical samples, an NLME model can pool observations. The approaches can be combined when an organ-based model is estimated using population data.