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 with open lines of direct communication with Study Directors and seamless study team collaboration from start to finish, including:

  • Grant support
  • Coordination with formulation CROs and CMOs on programs to optimize bioavailability or minimize immunogenicity
  • Preclinical advisory with study design guidance, IND program optimization and pre-IND meeting support

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. We have been performing GLP-compliant studies since 1979, and have successfully worked with many sponsors through IND submissions. IITRI also offers BSL-2 and BSL-3 containment facilities for GLP-compliant toxicology and safety studies.

Study Types

Bioanalytical

  • Method development and validation
  • Method transfer

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