Comparative Biosciences, Inc. offers GLP toxicology services by providing a complete program of GLP IND, Veterinary, and BLA-enabling toxicology for small molecules, large molecules, devices, combination products, and biologics including antibodies, proteins, botulinum toxin, stem cells, vaccines, viruses and nanoparticles. CBI has completed successful IND packages in the areas of oncology, botulinum toxin, stem cells, cancer vaccines, IBD, atherosclerosis, metabolic disease, and wound healing. Our toxicology clients include biotechnology, pharmaceutical, medical device, veterinary, governmental, agricultural, chemical, engineering, aerospace and manufacturing industries.
We feature rapid study initiation and report preparation to meet sponsor deadlines or milestones. We comply with FDA, USDA, OECD, and ICH guidelines. Our PhD study directors are experienced, communicative, and attentive, and we produce high-quality GLP reports in a very timely fashion.
CBI specializes in toxicology packages for unusual or problematic test articles/indications or aggressive time lines. Recent examples of unusual delivery routes would include successful studies using intra-cerebral delivery, intranasal delivery, intra-thecal, myocardial delivery, intra-tumoral delivery, intra-rectal delivery, human stem cells, drug combinations, and virus-associated anti-tumor test articles.
Regulatory Toxicology Studies
| Species | |||
|---|---|---|---|
| Rodents Transgenics-Knock outs-Mutants Cotton rats Immunocompromized mice and rats |
Guinea pigs Hamsters Gerbils |
Rabbits Ferrets Cats |
Dogs-Beagles and Hounds Minipigs Pigs Others upon request |
| Routes of Administration | |||
|---|---|---|---|
| Standard Routes Intravesicular Intravaginal Intra-rectal Intra-nasal Intradermal |
Ocular Aural Buccal Patches Devices Device-drug combination |
Infusion Dermal Topical Wounds Sublingual Nanoparticles |
Intra-thecal Intra-cerebral Intra-tumoral Intra-cardiac Intra-intestinal Others upon request |
| Types of Toxicology Studies | |||
|---|---|---|---|
| Acute Studies | Subacute & Subchronic | Chronic & Carcinogenicity | Special or custom toxicology |
| Dose ranging Maximum tolerated dose Acute Single dose Limit dosing |
1-week subacute 2-week subacute 4-week subchronic 8-week subchronic |
3-month chronic 6-month chronic 9-month chronic 1-year carcinogenicity 2-year carcinogenicity |
1-year chronic 2-year chronic Transgenic carcinogenicity Surgical toxicity Stem Cells Others upon request |