Preclinical Toxicology
We offer a complete program of preclinical toxicology services to support a range of your toxicology requirements. We have experience with early assessment of new molecules including single dose, multiple dose and targeted studies, as well as directed or investigative toxicology, IND-enabling toxicology programs and long-term carcinogenicity studies. Our facility can support a large volume of animals to support your acute toxicity studies, sub-acute toxicity studies, and chronic toxicity studies.
You will find our PhD study directors to be experienced scientists who are communicative, collaborative and attentive, and you can count on us to deliver high-quality GLP reports on time, every time.
Due to our unique and extensive experience in preclinical studies and state-of-the-art facilities, we have the skill and expertise to accelerate new drugs, small molecules, metals, biologics, tumorigenicity, stem cells, nano-particles, and devices from discovery through the drug development process, to regulatory submission and studies in man. We offer unique and sophisticated methods of assessment including OCT, digital radiography, CT scanning, ultrasound, MRI, laser doppler, IVIS imaging, and Silhouette photography. Additionally we offer immunohistochemistry, cytokines, ELISA, PCR, qPCR, and immunogenicity assays.
For GLP studies with biologics, stem cells, vaccines, viral products, proteins and large molecules, GLP studies include immunogenicity and biodistribution assessments.
Toxicology studies at CBI include:
- Skin irritation studies to intact or abraded skin
- Acute (LD50) dermal toxicity study in rats or rabbits
- Acute single or multiple dose dermal toxicity studies in rodents
- Acute single or multiple dose dermal toxicity studies in minipig or other nonrodent species
- Two week dermal toxicity studies in rodents
- Two week dermal toxicity studies in minipig, dog or other nonrodent
- Four week dermal toxicity studies in rodents (with or without recovery period)
- Four week dermal toxicity studies in minipig, dog or other nonrodent (with or without recovery period)
- 3, 6, or 12 month dermal toxicity studies in rodents (with or without recovery period)
- 3, 6, or 12 month dermal toxicity studies in minipig, dogs or other nonrodent (with or without recovery period)
- Two year oncogenicity dermal studies in rodents and nonrodents
- Co-carcinogenicity dermal studies in rodents and nonrodents
- Acute perivascular irritation study in rabbits
- Hyper sensitization studies
- Phototoxicity and UV light
- Customized toxicology studies to respond to FDA regulatory issues
- Toxicology with tumorigenicity, immunogenicity, and biodistribution, particularly for biologics and stem cells
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