Toxicologie de la reproduction : intérêt et interprétation

Developmental and reproduction toxicology studies (DART) are an essential part of the non-clinical dossier for a regulatory submission. They are performed according to internationally recognized and regulatory protocols. They allow a reasonable risk evaluation when a drug is given at any stage of the reproduction cycle. They study impact of the test compound on reproductive functions of both sexes, on pregnancy and embryo/fetal development, parturition and postnatal development of the progeny. The data interpretation and the establishment of safety margins lead to the edition of specific recommendations in the summary of product characteristics (SPC) and directly to the prescribers.