Toxicology

For more than 40 years, IITRI has been a premier provider of preclinical toxicology and drug safety evaluation services in accordance with GLP standards to the pharmaceutical and biotechnology industries. We offer you a full range of preclinical testing services to support submissions to the FDA and other regulatory agencies, including IND-enabling safety programs.

Our scientists provide the personalized attention and flexibility in communication that imparts the culture of a true partner. 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 experience in preclinical toxicology. We offer a stable study team, with the average tenure exceeding 15 years. This combination of partnership, experience and tenure provides you with a seasoned and stable study team that truly acts as an extension of your team.

Core Services

  • Acute, subchronic and chronic studies
  • Repeat-dose studies
  • Reproductive toxicology
  • Carcinogenicity studies
  • Clinical pathology and histopathology
  • Bioanalytical services
    • Dose formulation analysis
    • Bioanalytical method development and validation
    • Toxicokinetic analysis and modeling
    • ELISA-based method development and sample analysis

All Relevant In Vivo Models

  • Rat
  • Mouse
  • Guinea pig
  • Ferret
  • Rabbit
  • Canine
  • Minipig
  • Nonhuman primate

All Relevant Routes of Administration

  • Oral
  • Intravenous (bolus and infusion)
  • Dermal
  • Inhalation
  • Intratracheal
  • Intranasal
  • Subcutaneous
  • Intramuscular
  • Intraperitoneal
  • Ocular
  • Intradermal

The IITRI Advantage

  • One of the most experienced toxicology teams in the industry
  • Direct interaction with PhD-level study directors
  • Flexible, collaborative approach to study design to optimize cost and quality
  • Technical advisory and support regarding interpretation of study results
  • Expertise and facilities to accommodate in vivo studies in both small and large animal models
  • Comprehensive preclinical toxicology programs available to support IND and NDA submissions
  • On-site bioanalytical laboratory for the prompt analysis of preclinical samples