To investigate the systemic exposure and evaluate its gender-, time- and dose-dependency.
The biological samples (typically blood/serum/plasma) collected for toxicokinetic purpose are quantified by GLP fully validated bioanalytical method (e.g. LC/MS/MS, ELISA etc).
System suitability experiment.
In study validation according to the valid GLP guidelines.
Incurred sample re-analysis.
Detailed toxicokinetic evaluation as a part of the toxicology report
Concentrations presented in tabulated form and in figures
Calculation of the pharmacokinetic parameters by validated Phoenix WinNonlin software.
Comparison of the main exposure parameters and dose-normalized exposure parameters (Cmax, AUC, Cmax/dose, AUC/dose)