Current Assays in Endocrine Safety Pharmacology

Studies on endocrine safety pharmacology are part of the supplemental safety pharmacology studies, which are required as a consequence of endocrine-related findings in repeated-dose toxicity studies. Such findings may be changes in organ weight and/or histopathology, abnormal findings in biochemistry, and/or endocrine biomarkers. They are needed to detect undesirable pharmacodynamic effects of a substance on endocrine system in relation to exposure in the therapeutic range and above. The main objective is to decide whether the test compound can be administered to humans, which effects need to be monitored in clinical pharmacology and which clinical investigations are required for the risk evaluation.