Pharmaceuticals and chemicals have sometimes unanticipated and complex impacts on reproductive capacity and/or embryonic development: they can affect sexual function and fertility in adult males and females or lead to malformations, developmental retardations or mortality of the fetus when pregnant women are exposed. Over the past 30 years, fundamental understanding of embryogenesis and mechanisms of developmental toxicity have greatly advanced as well as the regulatory framework of the developmental and reproductive toxicology (DART) studies.
ERBC’ scientists have extensive experience in DART conducting a broad range of ICH and OECD-based studies in rodents and rabbits as well as advanced investigations in rats. They have implemented a historical control database to ensure accuracy and reproducibility of ERBC test results and develop next generation testing approaches that support the 3R principles.
ICH-based studies
All studies presented below can include toxicokinetic analysis
Fertility – Segment I: fertility and early embryonic development to implantation study
Species: rat (only females, only males, both sexes)
Administration routes: oral, subcutaneous, intravenous (by bolus or continuous infusion), intravaginal, intraperitoneal (at an appropriate dose regimen)
Teratology – Segment II: embryo-fetal development study (preliminary and main study)
Species: rat, rabbit, mouse
Administration routes: oral, subcutaneous, dermal, intravenous (by bolus or continuous infusion only in rat and rabbit), intravaginal, intraperitoneal (at an appropriate dose regimen)
Fertility and teratology – Segment I and II: combined study
Species: rat
Administration routes: oral, subcutaneous, intravenous (by bolus or continuous infusion), intravaginal, intraperitoneal (at an appropriate dose regimen)
