Table 2.

Comparing traditional pharmacokinetics approach to population approach.

	Traditional approach	Population approach
Population	Mostly in healthy volunteers	Target population
Sampling	Intensive (12–15 samples per subject)	Sparse (1–3 samples) and intensive sampling
Design	Needs to be balanced	Mixed designs; studies from different sources, populations, or sites
Complexity	Moderate	Computationally intensive and time consuming
Analysis approach	Two steps: Nonlinear regression followed by summary statistics	All data at once using nonlinear mixed effects modeling
Variability	Minimized by design or selection criteria	More reflective of true population
PK-PD exposure response analysis	Cannot be applied	Possible