Pharmacometrics
Uses quantitative models of drug exposure, response and variability to support drug development decisions.
Uses quantitative models of drug exposure, response and variability to support drug development decisions (FDA. Division of Pharmacometrics.).
A dose-selection analysis can estimate a population PK model from measured concentrations, simulate exposure under candidate regimens, and evaluate efficacy and safety against those exposures. Each step needs its own evidence: good concentration predictions alone cannot establish a benefit–risk balance.