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
- Genetic toxicology
- Ames assay
- Structural chromosomal aberration assay
- Mouse micronucleus assay
- Mouse lymphoma assay