Aim: To assess the systemic exposure to test compound in preclinical species after administration as support to toxicological studies.


Background information: Toxicokinetic evaluations help to relate plasma concentrations of test compound (or metabolites) to the observed toxicity and guide dosing recommendations for clinical trials.

The toxicokinetics assessment is done by determining test compound concentrations in plasma from toxicological studies. At preset times and day of administration, blood samples are collected from each animal. Bioanalysis is done by UPLC-MS/MS after previous sample treatment (solid phase extraction, protein precipitation) with/without validated method (GLP/non-GLP study).

Experimental design:

Dose, route, and samples: variable with study
Animal species: rodent, non-rodent
Dosage regime: single or multiple dosing
Analytical method: UPLC-MS/MS quantification in plasma using calibration curves. Bioanalytical method is validated previously when study is done following GLPs.

Delivered results:

Standard toxicokinetic parameters determined by non-comparmental analysis
Statistical analysis of toxicokinetic parameters