The ILS In Vivo Toxicology team conducts pre-clinical safety and efficacy studies to meet regulatory requirements and non-GLP investigative studies supporting discovery research.
ILS routinely provides regulatory toxicology testing in rodent species to comply with OECD, FDA and EPA test guidelines and meet US FDA, US EPA, ICH and worldwide regulatory agency requirements.
We utilize the latest genomic profiling techniques to investigate mode-of-action and risk assessments, and regularly integrate services with other ILS teams to support in vivo toxicogenomic studies.
We have extensive experience in designing, conducting, evaluating and interpreting study results that cover various endpoint analyses (toxicology, pathology, biochemical and molecular), and can draw on the full range of ILS services from genetic and in vitro toxicology to pathology and histology.
Which means we can efficiently get you the data you need, in the format you require (including eCTD compliant reports and SEND compliant datasets), so you can make timely and fully informed decisions regarding mode-of-action and potential adverse effects and relevance to humans.
In addition to traditional regulatory toxicology studies, ILS also designs in vivo toxicogenomic studies that include dose-response and bioinformatics, to determine differentially expressed genes and genomic response pathways, and derive benchmark dose used in risk assessments.
- FDA, EPA, and OECD-compliant regulatory studies
- Acute, sub-chronic and chronic toxicity testing
- Pharmacokinetic/Toxicokinetic studies
- Cancer Bioassay (CARC)
- Traditional two-year assay
- Six-month genetically modified model studies
- Animal studies for mechanistic-based research
- Neurotoxicity/behavior testing (FOB)
- Vaccine safety and efficacy
- Reproductive and developmental toxicity
- Immunotoxicity Chemoprevention studies
- Study design, protocol development, and implementation
- Administration of test article (e.g. oral, subcutaneous, intravenous, intramuscular, intradermal, footpad, intratracheal, pharyngeal aspiration, feed, water, osmotic minipumps and implantation)
- Toxicogenomic studies to evaluate mode-of-action and perform risk assessments
- Specialized surgical procedures
- Urine, fecal and blood collection
- Tissue collection and preservation for DNA and RNA analysis
- Cell sorting/isolation and characterization
- Whole body and organ perfusion
- Characterization/Grading/Mapping of lesions
- Caliper measurements
- Conventional rodent models
- Immuno-compromised rodents
- Alternative mouse models – genetically modified
- Breeding, genotyping, phenotyping and various animal models of disease
- Breeding animals for protocol specific research studies
- Transgenic: genotypic, phenotypic and histopathological characterization
- Breeding onto susceptible background strain
