Charles River offers overall developmental and reproductive toxicology (DART) program planning and individual study design to conduct safety assessments for your products according to internationally recognized guidelines, including ICH and OECD.
Key Takeaways and Considerations from Revision Three of ICH S5
This webinar analyses its key takeaways and how the revisions may impact your drug development program.
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We conduct male and female fertility, developmental toxicity (embryo-fetal development), pre- and postnatal development and multigenerational studies, (including OECD 443, the Extended One Generation Reproductive Toxicity Study, (EOGRTS)), to assess the potential effects of novel products on the entire reproductive spectrum. Our expertise includes pharmaceuticals (including vaccines, biopharmaceuticals, and veterinary and medical devices) agrochemicals, industrial chemicals and food additives.
We collaborated with the International Molybdenum Association on an OECD 416 study, assessing the potential of sodium molybdate dihydrate to induce reproductive toxicity in male and female Sprague Dawley rats. Download the White Paper
A full range of rodent and nonrodent species are tested with dose routes ranging from dermal to intravenous infusion. A range of specialized functional evaluations is also available, including neurobehavioral testing and immunologic assays. All studies are supported by our own laboratory and regulatory experts.
- Developmental and reproductive pathology
- Specialized neurobehavioral testing
- Functional assessments, including growth (and the skeleton), pulmonary, neurobehavioral, reproductive and immunological development
- Toxicokinetic evaluations, including induction studies
- Juvenile toxicity testing in rodents and nonrodent species
- Screening Information Data Sets (SIDS)
- Hormone assays
- Male reproductive assessments in rodents and nonrodents
- Variety of behavioral tests (e.g., activity and learning and memory) for pre- and postnatal and multigenerational studies
- Range of developmental immunology tests that can be added to pre- and postnatal and multigenerational studies
- Endocrine disruptor screenings (in vivo and in vitro)
- Skeletal measurements (e.g., bone size, geometry and density) for pre- and postnatal studies using micro-CT, pQCT, X-ray and DXA
- Sperm/oestrous cycle analyses
For a full list of functional evaluations, view our Specialty Endpoints in Developmental and Reproductive Toxicology (DART) Technical Sheet*. (*Available in the Source℠)