An integrated evaluation of potential risks to development and reproduction is a key component in many marketing authorization applications.
Citoxlab offers developmental and reproductive toxicology (DART) studies accepted by worldwide regulatory authorities for the safety testing of pharmaceuticals, biologics, gene-therapy products, food additives, chemicals, agrochemicals, veterinary medicines and consumer products. Studies cover the whole scope of developmental and reproductive toxicology, testing for potential effects on fertility, through embryo‑fetal, post-natal and juvenile stages, up to the second generation.
Specialized evaluations can be combined in your DART studies, such as neurobehavioral testing, sperm/oestrous cycle analyses, developmental immunotoxicology, neuro-histomorphometry, skeletal development (X-ray, DXA, pQCT and microCT), genomics and extended one-generation reproductive toxicity study (EOGRTS).
By the way, since its adoption in 2011, the EOGRTS (OECD 443 test guideline) has become a key milestone in the assessment of potential effects of chemicals on fertility and development, including effects on the developing nervous and immune systems.
Thanks to a solid expertise in Developmental and Reproductive Toxicology, Citoxlab has the experience and know-how required for managing such a complex study and has already built a robust Historical Control Dataset.
In this Webinar, using experience gained during the conduct and reporting of EOGRTS, Citoxlab will present the lessons learned and discuss the development and benefits of conducting such a study, with special focus on the challenges faced both by registrants and CROs in meeting the volume of demand for those in the coming years.