Extended Pharmacokinetic Study

Extended pharmacokinetic study measures drug and metabolite concentrations over prolonged periods characterising elimination kinetics and accumulation potential. Terminal phase slopes determine elimination half-lives. Accumulation ratios predict steady-state concentrations from single-dose data. Metabolite pharmacokinetics characterise active metabolite formation and elimination.

Repeat-dose pharmacokinetic studies assess whether steady-state pharmacokinetics differ from single-dose predictions. Time-dependent pharmacokinetics from enzyme induction or inhibition warrant monitoring at multiple time points. Bioavailability assessment across diverse populations identifies pharmacokinetic variability. Regulatory submissions incorporate extended pharmacokinetic data supporting dose selection. Emerging population pharmacokinetic modelling predicts individual exposure from limited sampling.