Performed in all species, oral gavage as well an injection routes (intravenous, subcutaneous, intramuscular, intradermal and intraperitoneal) are performed in all conventional toxicology species and for a wide range of dosing durations. Our extensive experience in performing studies by these routes of administration uniquely positions ITR Laboratories to meet your testing requirements.

ITR Laboratories was established with the goal of becoming a world leader in infusion technology. The facility was designed and built with this in mind encompassing a surgical suite, animal rooms and all the necessary equipment (surgical equipment, infusion pumps, special cages, etc.) and services to support the conduct of infusion toxicology studies.

ITR Laboratories continues to build on its strengths and reputation for quality pre-clinical infusion studies in a variety of animal species such as rats, dogs, monkeys, rabbits and minipigs.

Over the years, we have performed almost 800 infusion studies, helping us accumulate considerable experience working with a wide variety of compounds such as anticancer, oligonucleotides, monoclonal anti-bodies, antibiotics, anti-virals, anti-coagulants, hormones, cardiovascular compounds, etc. Consequently, we are able to assist sponsors administer their duration test ranging from minutes to 9 months. To achieve this, great lengths have been taken to ensure that the highest quality sterile techniques, pre- and post-operative care and components of the surgically implanted catheters and connecting tubes are used.

Our scientific staff, including study directors and pathologists, have extensive experience, recognize background findings and are able to isolate them from potentially compound-related finding.

To meet the growing demand in respiratory drug delivery, purpose-built inhalation facilities for conducting GLP toxicology studies were completed at ITR Laboratories in 2002. With extensive international inhalation toxicology experience, the scientific and technical inhalation team at ITR Laboratories has conducted over 700 studies to date with durations ranging from single dose to two-year carcinogenicity studies.

Our inhalation technologists have extensive experience in the generation and characterization of respirable aerosols from complex powders, liquids and gases from the pharmaceutical, chemical and agro-chemical fields.

More on our Facilities:

• Onsite analytical facilities support rapid formulation and aerosol characterization.

• Rodent inhalation rooms with containment cabinets for aerosol generation.
• Separate treatment and control exposure rooms for large animals to prevent risk of cross-contamination.
• Room ventilation systems engineered to limit cross-contamination possibilities.
• Flow-Past Technology: Minimizes the amount of drug requirement; Avoids alternative exposure routes; Eliminates potential eye irritation; Precise control of exposure for each individual animal.
• Customized platform restraints used for dogs and minipigs
• Custom designed chair restraints used for primates.
• Aerosol Monitoring Equipment:
  • Filter sampling devices
  • Liquid Impingers
  • Liquid Traps/Bubblers
  • Gravimetric and chemical analysis
  • MMAD/ GSD
  • Gravimetric and/or chemical assessment in order to ensure that aerosols within the respirable range for test species.

More on our Experience:

• Experience with rodents, dogs, non-human primates and nano/minipigs.
• Dedicated Subject Matter Experts –Aerosol Scientists and Inhalation Toxicologists with over 100 years of combined experience.
• Aerosol generation and characterization expertise with Dry Powder Formulations, Nebulized Solutions/Suspensions, as well as gases.
• Experience with a wide variety of molecules: Vaccines, Chemicals, Small and Large molecules, including gene therapy.
• Repeat dose insufflation and instillation techniques for early-stage test article candidate screening & for efficacy testing in disease models.
• Intranasal Administration capabilities in rodents and large animals using in-house or client-specific devices.

Ocular, a specialty service offered at ITR Laboratories can be performed by topical application of drops onto the surface of the eye by our trained technical group or by injection into the vitreous/aqueous humor by using a needle. Such injections are performed at our facility by a board-certified veterinary ophthalmologist contracted by ITR Laboratories.

Parameters monitored during ocular studies may include the following:

• Pupil diameter measurement (Pupillometry)

• Intraocular pressure (Tonometry)

• Corneal thickness measurement (Pachymetry)

• Biomicroscopic (Slit lamp) examinations with a modified Hackett-McDonald scoring (using a suitable topical mydriatic, such as 1% tropicamide HCL)

• Indirect ophthalmoscopy

• Specular microscopy

• Gonioscopy

• Electroretinography

Dermal application is generally performed in rats, rabbits and/or mini pigs. ITR Laboratories has performed studies of up to 26 weeks in rats and 39 weeks in mini pigs. For repeated dose designs it is generally accepted that the dosing sites are non-occluded.

Our technical group has extensive experience in assessing dermal changes in laboratory animals and results are recorded directly into Provantis, which is a fully integrated data capture system used throughout the ITR Laboratories facility.

Otology, a new service provided by ITR Laboratories encompasses two main disciplines.

The first allows us to measure the Auditory Brainstem Response (ABR) to different sound levels in animals that are part of a standard toxicology study. This service is offered to clients that are developing a drug that is in a class that may cause hearing loss. Results of the measurements are sent to a board-certified consultant on otology.

The second use of this service is related to efficacy of treatment being developed to correct hearing loss. This is achieved either via a standard route of administration or instillation directly into the middle ear. ITR Laboratories continues to develop methods to administer to the inner ear.

Structures and tissues of the ear can be collected for histopathological evaluation and electron microscopy.