PKPDAnalysen
PKPDAnalysen (pharmacokinetic/pharmacodynamic analyses) are quantitative methods used to describe and predict how a drug's exposure relates to its therapeutic and adverse effects over time. By combining pharmacokinetics (how the body processes a drug) with pharmacodynamics (the drug's biological effects), PKPDAnalysen support dose selection, regimen optimization, and risk assessment.
Data for PKPD analyses typically come from concentration-time profiles in biological samples and corresponding pharmacodynamic endpoints
Population PK/PD uses nonlinear mixed-effects modeling to quantify typical effects and variability across individuals and covariates
Applications include dose optimization in adults and special populations (pediatrics, renal/hepatic impairment), assessment of drug–drug interactions,
Limitations include model misspecification, identifiability issues, data quality, and the assumption that models generalize beyond studied