Toxicology

IITRI is a premier provider of preclinical toxicology and drug safety evaluation services in accordance with GLP standards, with over 40 years of experience providing these services to the pharmaceutical and biotechnology industries. We offer 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