Regulatory Toxicology Services at CBI
CBI offers a complete regulatory toxicology program to support GLP IND, veterinary and BLA-enabling regulatory submissions for a variety of compounds. Our experts have years of experience working with small and large molecules, medical devices, combination therapeutics, stem cells, biologics, nanoparticles and other substances. Additionally, we have a shorter downtime to start your regulatory
We have completed successful IND packages in the areas of oncology, botulinum toxin, dermal disease, stem cells, cancer vaccines, IBD, atherosclerosis, metabolic disease, ocular disease, and wound healing.
Our strength is providing toxicology packages for unusual or problematic test articles and indications or with aggressive timelines.
Our vivarium comes fully equipped to handle a large volume of small and large animals. Our species capability range from mice and rats to dogs and pigs. Our facility also includes a state of the art histopathology laboratory which allows us to expedite the completion of your toxicology study. All of our slides are ready by a board certified veterinary pathologist and all of our GLP reports are prepared for successful regulatory submission.
Have a question about our services? Contact us today!
Regulatory Toxicology Studies
ROUTES OF ADMINISTRATION
- Standard routes
- Intravesicular
- Intravaginal
- Intrarectal
- Intranasal
- Intradermal
- Ocular
- Aural-otic
- Buccal
- Patches
- Devices
- Device-drug combination
- Infusion
- Dermal
- Topical
- Wounds
- Sublingual
- Nanoparticles
- Device stem cell combination
- Intrathecal
- Intracerebral
- Intratumoral
- Intracardiac
- Intra-intestinal
- Others upon request
TYPES OF TOXICOLOGY STUDIES
Acute Studies
- Acute
- Dose ranging
- Limit dosing
- Maximum tolerated dose
- Single dose
Subacute & Subchronic
- 1-week subacute
- 2-week subacute
- 4-week subchronic
- 8-week subchronic
Chronic & Carcinogenicity
- 3-month chronic
- 6-month chronic
- 9-month chronic
- 1-year carcinogenicity
- 2-year carcinogenicity
Special or custom toxicology
- 1-year chronic
- 2-year chronic
- Stem cells
- Surgical toxicity
- Transgenic carcinogenicity
- Others upon request
References:
- Meschter, C. L., Mico, B. A., Mortillo, M., Feldman, D., Garland, W. A., Riley, J. A., and Kaufman, L. S. A 13-week toxicologic and pathologic evaluation of prolonged cytochromes P450 inhibition by 1-aminobenzotriazole in male rats. Fundam Appl Toxicol, 22: 369-381, 1994.
- Conaway, C. C., Upadhyaya, P., Meschter, C. L., Kurtzke, C., Marcus, L. A., and el-Bayoumy, K. Subchronic toxicity of benzyl selenocyanate and 1,4-phenylenebis(methylene)selenocyanate in F344 rats. Fundam Appl Toxicol, 19: 563-574, 1992.