The relevance of experimental reproductive studies in safety assessment

Abstract Traditional methods for assessing reproductive toxicity in preclinical species are of general proven worth and human relevance. Current ICHS5(R2) reproductive studies for pharmaceuticals have a minimalist design compared to other sectors and could benefit from re-consideration of longer dosing periods especially for drugs intended for chronic administration, single gender testing and other more minor modifications. There is poor understanding of the effects of most pharmaceutics on human reproductive health but case examples exist where human monitoring, especially semen studies, have facilitated approval and patient use. Better methods are needed to assess long term effects, particularly on ovarian reserve and female reproductive health. Novel methods of sperm assessment that are potentially translatable across species require greater consideration. Based on emerging understanding of genomic alterations that impact human health and disease, future reproductive test methods may eventually require modification to accommodate new tests of germline integrity.