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At IITRI, we recognize that animal studies play an essential role in assessing the safety of pharmaceuticals and environmental or occupational chemicals, and in advancing our understanding of disease prevention, control, and treatment.
We are committed to providing the best possible environment for animals in our facility, and to the humane and ethical treatment of all species of animals in our care. We ensure the animals’ well-being through a variety of enrichment activities, species-specific activity and behavior opportunities, social housing, positive reinforcement training, and species-specific fresh food enrichment. We also recognize that a humane animal care program contributes to generating high-quality scientific data, reinforcing our commitment to providing the highest-quality studies possible for our clients.
Our animal care program is supervised by a full-time board certified, state licensed, and USDA accredited veterinarian. Institutional oversight, policy, training, and programmatic review are performed by our Institutional Animal Care and Use Committee (IACUC). Our management and staff are dedicated to following the animal welfare “Five Freedoms” concept originating in the UK in 1965, proposing that animals’ needs can be met by safeguarding these five principles:
Freedom from Hunger and Thirst – by ready access to fresh water and a diet to maintain full health and vigor.
- Freedom from Discomfort – by providing an appropriate environment including shelter and a comfortable resting area.
- Freedom from Pain, Injury or Disease – by prevention or rapid diagnosis and treatment.
- Freedom to Express Normal Behavior – by providing sufficient space, proper facilities and company of the animal’s own kind.
- Freedom from Fear and Distress – by ensuring conditions and treatment which avoid mental suffering.
Our animal care program complies with the requirements of the following guidelines and agencies:
- The Guide for the Care and Use of Laboratory Animals, NRC, 2011
- PHS Policy on Humane Care and use of Laboratory Animals
- The Animal Welfare Act and Animal Welfare Act Regulations
- Food and Drug Administration (FDA) and Environmental Protection Agency (EPA) Good Laboratory Practice (GLP) Regulations
In vivo pharmacokinetic (PK) studies can be instrumental in the screening and selection of lead compounds with desirable bioavailability profiles for further investigation in drug development programs. Well-designed PK studies provide drug exposure data to assist in the study design and species selection of preclinical studies, including dosing schedule and dose levels. PK analysis prior to nonclinical toxicology studies verify that the formulation and dose form provides adequate drug exposure in the test animal.
IITRI offers a comprehensive solution for non-GLP PK studies that includes quick turnaround PK screening for lead optimization or formulation evaluation, and full PK programs that encompass the in-life study, bioanalysis and PK modeling. Studies can be conducted in rodents and nonrodents, including ferrets, dogs, mini pigs, and nonhuman primates (NHPs).
Bioanalysis is performed at our Chicago facility for determination of small molecules or biologics in blood, urine, plasma, serum, CSF, or tissues. Our state of the art bioanalytical capabilities include LC-MS/MS – AB SCIEX 5500 and robotic sample prep systems. Biologic drugs may be determined using ELISA or qPCR assays.
PK Study Options
- Biodistribution and bioequivalence
- In vivo ADME
- Studies using radiolabeled drugs
Routes of Administration
- Continuous infusion
- Rodents (mice, rats)
- Nonrodents (ferrets, guinea pigs, rabbits, canines, mini pigs
- Nonhuman primates (NHPs)
The IITRI Advantage
- Rapid turnaround from study initiation through generation of final report
- Highly experienced team of analytical chemists with more than 60% of the team holding advanced degrees
- Flexible, collaborative approach with customized study designs