Investigate the relationship between the pharmacodynamic/toxicity response(s) and the corresponding systemic/target site exposure of the test item.
In life phase:
Biological evaluation and bioanalysis:
Monitoring the pharmacodynamic effect: application of the relevant methods to measure the specific responses and concentrations of the relevant biomarkers e.g:
Monitoring of the exposure: quantification of the test item in plasma and/or target matrix (by LC/MS/MS, ELISA etc.)
Correlation between the test item concentrations/total exposure and the biological response(s) for a defined time period.