Carina Schaefer
Germany
Research Article
Combined Pharmacokinetic Model for Lacosamide and its Main Metabolite
for Integrated Pharmacokinetic Modeling in Humans
Author(s): Carina Schaefer and Willi CawelloCarina Schaefer and Willi Cawello
Pharmacokinetic (PK) modeling and simulation are fundamental to describe a drug’s fate in a biological system. An understanding of therapeutically effective drug concentrations, dose-related adverse events and appropriate dosing schedules can be informed by PK. Combined PK models that include the model-dependent PKs of a drug and its metabolites in plasma and unchanged drug in urine broadens the spectrum of separated PK models. Software used for PK modeling was validated and evaluated by simulating concentration-time data of a fictive study population. Results of precision and accuracy were under 15% and met criteria for bioanalytical method validation. The PK model was applied to lacosamide and its main metabolite in plasma and lacosamide excreted in urine of healthy subjects and subjects with mild-to-severe renal impairment of a Phase I trial. Resulting PK parameters were cons.. View More»
