IND-Enabling Studies

IITRI has decades of experience evaluating the preclinical safety of small molecule drugs and biologics to support IND/NDA submissions of new drug candidates. We work with you to plan and execute essential IND-enabling studies including GLP-compliant repeat-dose studies in rodents and non-rodents, genetic toxicology studies and nonclinical safety pharmacology. In addition, our onsite analytical laboratory provides a full range of services to support the bioanalysis of fluids and tissues to determine drug exposure.

We offer a collaborative approach that includes:

  • Preclinical advisory with study design guidance, IND program optimization and pre-IND meeting support
  • Coordination with formulation CROs on programs to optimize bioavailability or minimize immunogenicity
  • Open lines of direct communication with Study Directors and seamless study team collaboration from start to finish

The IITRI team excels at interfacing with small to mid-size biopharma to navigate and execute a program of preclinical safety and toxicology studies necessary for IND submission.

  • Bioanalytical method development and validation
  • Toxicology (repeat dose)
    • All routes of administration including inhalation
    • All relevant animal models including NHPs
  • Safety pharmacology
    • CNS
    • Cardiovascular
    • Respiratory
  • Genetic toxicology
    • Ames assay
    • Structural chromosomal aberration assay
    • Mouse micronucleus assay
    • Mouse lymphoma assay