Database with reprotox data on platform (D7.8)

Regulatory non-clinical safety testing of human pharmaceuticals typically requires embryo–fetal developmental toxicity (EFDT) testing in two species (one rodent and one non-rodent). This deliverable aimed to rank of Non-Clinical Rat and Rabbit Embryo-fetal Developmental Toxicity Data compared to maximum recommended human therapeutic dose. Data were obtained from a database of compounds that was established by CBG and RIVM, based on publicly available data. Out of the 58 compounds, 50 were classified as increased concern for human teratogenicity. This ranking based on pre-clinical data should be combined with drug utilization data (D7.17) to assess exposure risks and prioritization of RWE studies.