ROUTES OF ADMINISTRATION

ITR Laboratories Canada premium services include infusion and inhalation, which are complemented by general toxicology dosing methodologies as well as the increasingly relevant ocular, dermal and otology routes.

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

ITR Laboratories Canada 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 Canada 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 Canada in 2002. With extensive international inhalation toxicology experience, the scientific and technical inhalation team at ITR Laboratories Canada has conducted acute, sub-chronic, chronic, and carcinogenicity experiments with exposures in rodents, dogs and non-human primates. Our inhalation technologists have extensive experience in the generation and characterization of respirable aerosols from complex powders, liquids, metered-dose inhalers and gases from the pharmaceutical, chemical and agro-chemical fields, with almost 400 studies conducted to date.

FACILITIES:

The inhalation department includes rodent and large animal exposure rooms and conventional lab areas. The rodent inhalation rooms are equipped with containment cabinets for aerosol generation, exposure and monitoring systems, and the large animal rooms with service stations to provide compressed air for aerosol generation, exposure and monitoring systems. Exhaust systems in each containment cabinet and at each service station are linked to a central vacuum system to prevent any risk of cross contamination of aerosols. Onsite analytical facilities support rapid formulation and aerosol characterization.

ADDITIONAL CAPABILITIES:

Intratracheal instillation and insufflation: ITR Laboratories Canada has developed repeat dose insufflation and instillation techniques. This route of administration has proven popular in early stage test article candidate screening prior to embarking on an inhalation program. The route is also commonly used at ITR Laboratories Canada in 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 Canada 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 Canada.

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 Canada 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 is assessing dermal changes in laboratory animals and results are recorded directly into Provantis v9, which is a fully integrated data capture system used throughout the ITR Laboratories Canada facility.

Otology, a new service provided by ITR Laboratories Canada 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 Canada continues to develop methods to administer to the inner ear and hope to have this completed by mid of 2017.

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