IND-Enabling Studies

IITRI has over 40 years of experience evaluating the preclinical safety of small molecule drugs and biologics to support IND/NDA submissions of new drug candidates. As a full-service CRO, we offer complete IND-enabling programs including GLP-compliant, repeat-dose toxicology in rodents, non-rodents, and non-human primates (NHPs), along with genetic toxicology, and nonclinical safety pharmacology studies, all designed specifically for your drug candidate. Studies are conducted efficiently at our single Chicago-based facility, with our onsite analytical, clinical pathology, and pathology laboratories providing a full range of study services under one roof. As a mid-size CRO, we offer the personalized interactions you would expect from an extension of your study team.

Our Collaborative Approach

The IITRI team excels at interfacing with small to mid-size biopharma to navigate the challenges of designing and planning the first steps of moving a new drug towards the clinic. We offer expert guidance in designing a program of regulatory-compliant preclinical safety and toxicology studies for FDA submission, and have successfully worked through IND submissions with many sponsors. Our collaborative approach includes:

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

Complete IND-enabling Programs

Toxicology (repeat dose)

  • All routes of administration including dermal and inhalation
  • All relevant animal models including minipigs and NHPs
  • non-GLP dose range finding (DRF) and maximum tolderated dose (MTD) studies
  • GLP-compliant definitive repeat-dose 28-day studies
  • ABSL-2 facilities for viral vector studies

Safety pharmacology

  • CNS
  • Cardiovascular
  • Respiratory

Genetic toxicology

  • Ames assay
  • In vivo: Structural chromosomal aberration assay, mouse micronucleus assay
  • in vitro: micronucleus assay (TK6 cells), mouse lymphoma assay

Drug types

Download IND-enabling Brochure