Preclinical
ESR carries out the analysis of animal samples (tissue and plasma) to establish pharmaco- and toxico- kinetics of new chemical entities. The institute acts as a principal investigator in these studies.
Early Phase
ESR carries out the analysis of samples collected during Phase 1 or 2 clinical studies in the development of new therapeutic products. Analytical validation and control are carried out in accordance with FDA guidelines.
Bioequivalence
ESR carries out the analysis of samples from studies designed to show equivalence of therapeutic products. The analyses are carried out in accordance with FDA guidelines. The institute generally specialises in the high potency, low plasma level drugs that require mass spectral detection.