Toxicology services - more than 15 years of experience
Agilex Biolabs’ offers rodent toxicology services through its company TetraQ toxicology. The toxicology team’s experience conducting in-life trials spans over 15 years working with clients from universities and biotech companies.
The toxicology services operate in our NATA-accredited, GLP-recognised facility on a two-year audit cycle. Toxicity and pharmacokinestics studies are run in a dedicated vivarium with capacity for over 500 rats and 300 mice in individually ventilated cages with ample floor space.
Toxicology studies are eligible for the attractive 43.5% tax rebate, and are subject to an ethics approval process before commencing. Trials are run by a dedicated team of scientists operating under an experienced head of toxicology and pharmacokinetic services. Both single and repeat dose studies are possible. We provide routes of administration that include oral, intravenous, intramuscular, intradermal, subcutaneous and intraperitoneal modes, and a cannulated rat model.
Study outcomes include the identification of a maximum tolerated dose (MTD) of the test item. Trial results can be used to support the design of both key efficacy studies and formal GLP toxicology studies. Formal toxicity studies can in turn support first-in-human studies. GLP studies employ a test item manufactured under Good Manufacturing Practice (GMP) and a study design informed by non-GLP exploratory toxicity studies as well as the intended clinical use. GLP studies are subject to Quality Assurance (QA) audit, as their results are intended to facilitate the safe design of clinical studies.
Study management and data collection are supported by an FDA 21 CFR Part 11-compliant Provantis software system. Provantis is used for recording of body weights, clinical observations, dosing, food and water consumption and blood or urine sampling as well as other user-specified outcomes. Interim and final reporting is facilitated by centralized data collection, allowing rapid delivery of written reports to clients.