Comparative Biosciences, Inc. (CBI), a preclinical contract research organization (CRO), offers regulatory toxicology services by providing a complete program of GLP IND and BLA enabling toxicology for small molecules, biologics including botulinum toxin, viral, stem cells, vaccines, nanoparticles, and devices. CBI has completed successful IND packages in the areas of oncology, botulinum toxin, stem cells, cancer vaccines, IBD, atherosclerosis, metabolic disease, and wound healing.
Regulatory Toxicology Studies
| Species | Routes of Administration | Types of Toxicology Studies |
|---|---|---|
| Rodents Guinea pigs Hamsters Ferrets Gerbils Rabbits Cats Dogs Minipigs Pigs |
Systemic (all routine routes) Ocular Buccal Dermal-topical-wound Intracardiac Intracerebral/cranial Intradermal Intratumoral Intranasal Intrarectal Intravaginal Intravesicular |
Maximum tolerated dose or single ascending dose Acute: single dose or multiple dose Subacute: 7, 14, 28 day studies Chronic: 3, 6, 12 month, and 2 year studies Carcinogenicity Standard species Transgenic/knockouts Stem cell studies Surgical models with toxicology Wound healing studies Ocular studies Custom studies |
Species for regulatory toxicology studies include rodents, small animals, ferrets, gerbils, rabbits, dogs and pigs/minipigs, by standard and unusual or specialized routes of administration.
We feature rapid study initiation and report preparation to meet sponsor deadlines or milestones. We comply with FDA, OECD, and IHC guidelines and have a validated computerized toxicology data acquisition program (LABCAT). Our study directors are experienced, communicative, and attentive, and we produce high-quality GLP reports in a very timely fashion.
We specialize 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 intracerebral delivery, intranasal delivery, myocardial delivery, intratumoral delivery, intrarectal delivery, human stem cells, and virus-associated test articles. CBI recently has completed successful IND packages in the areas of oncology, stem cells, CNS, IBD, atherosclerosis, metabolic disease, and wound healing.