Advantages | Disadvantages |
---|---|
Traditional PK | |
Small numbers of participants required (usually < 20) | Often done in “healthy” participants rather than the target patient population |
Minimizes interindividual variability via fixed, restrictive sampling designs | Multiple blood samples required from each participant |
Simple PK modelling and calculations | Cannot handle sparse sampling or identify covariates affecting variability in drug concentrations |
Population PK | |
Often done in patients for whom the drug was intended | Large clinical samples required |
Accommodates flexible study designs, handles sparse sampling, and requires few blood samples from each patient | Entails handling large amounts of data |
Quantifies covariates accounting for interindividual PK variability (e.g., age, weight, smoking, concomitant medications) | Complex statistical analyses (e.g., model building, diagnostics, missing data treatment) |
PK = pharmacokinetic.