Toxicology

IITRI is a high-quality provider of preclinical toxicology and drug safety evaluation services in accordance with GLP standards, with over 40 years of experience partnering with pharmaceutical and biotechnology sponsors. We offer a full range of in vivo toxicology testing services to support submissions to the FDA and other regulatory agencies, including complete IND-enabling programs, and chemical toxicity assessment for pesticide or REACH registration.

Our toxicology team is one of the most experienced in the industry, with PhD/DABT study directors and study team technicians possessing greater than 10 years of tenure in preclinical toxicology. We provide personalized attention to your study, including ensuring your study design and execution meets regulatory and timeline requirements.

Acute and Chronic Toxicity Studies

IITRI offers customized acute or chronic toxicology study designs for the unique requirements of your non-GLP or GLP-compliant study goals. We also offer non-clinical toxicology studies of longer duration may be required for regulatory approval of new drugs (NDA-enabling).

• Maximum-tolerated dose (MTD)
• Dose-range finding study (DRF)
• Acute, subchronic and chronic toxicity studies
• Repeated dose toxicity studies
• Reproductive toxicology including juveniles
• Carcinogenicity studies including 2-year and 6-month transgenic mice

Onsite Bioanalytical, Histopathology, and Clinical Pathology

As a full-service CRO, all aspects of a toxicology study are completed at IITRI’s single Chicago-based site. Our onsite support laboratories ensure seamless transfer of samples and data between study teams, and effective communication between groups for troubleshooting and coordination of activities.

• Clinical pathology and histopathology
• Bioanalytical services

All Relevant Species

• Rodent: mouse, rat, guinea pig, rabbit
• Non-rodent: canine, minipig, ferret
• Nonhuman primate: marmoset, cynomolgus monkeys, rhesus macaques, african green monkeys

All Relevant Routes of Administration

• Oral
• Intravenous (bolus and infusion)
• Dermal, intradermal
• Inhalation, intratracheal, intranasal
• Injection (subcutaneous, intramuscular, intraperitoneal)
• Ocular (injection, eye drops)

Drug Classes

• Small molecules
• Biologics (proteins, antibodies, DNA/RNA)
• Vaccines
• Viral vectors
• Gene and cell therapies
• Nanoparticles

Facilities

Our preclinical facilities cover over 110,000 ft2 of laboratory and support space and includes 48 rooms for housing of all standard rodent and non-rodent species. Our ABSL-2 and ABSL-3+ containment suites are available for toxicology studies involving pathogenic agents, and 10 inhalation exposure suites are available for studies in small and large animals. A fully staffed clinical pathology laboratory and laboratories for analytical and bioanalytical chemistry, microbiology, biochemistry, cell biology, and molecular biology provide support services.

Accreditations

The IITRI vivarium is fully AALAC-accredited, USDA registered, and operates under an Animal Welfare Assurance (#A3475-01) approved by the NIH-OLAW.