Toxicology - General Toxicology
Toxicology study types
In general, toxicology studies are performed in 2 species (a rodent and a non-rodent). Initially studies are performed in a stepwise fashion starting with a Maximum Tolerated Dose (MTD) study, followed by a Dose Range Finding (DRF) study.
The MTD and DRF studies are used to set the appropriate dose levels and to some extent also choose the species to be used in the repeat-dose toxicity studies. Following the MTD and DRF studies, a number of repeat-dose toxicity studies can be performed. For IND (investigational new drug) enabling studies we will typically perform 4-week toxicity studies.
Later in the drug development phase chronic studies with a duration of up to 6-12 months can be performed to ensure that the expected clinical trials are covered by the pre-clinical studies in terms of dosing frequency and duration of the general toxicology studies.
At Scantox we offer general toxicology studies in both rodents and a non-rodent, and our technical staff are very experienced and highly skilled in handling and dosing of animals.
All standard routes of administration e.g. oral (via gavage, using capsules/tables or mixed in the diet), dermal, intramuscular, subcutaneous and intravenous are performed. If needed animals can be fitted with vascular catheters to allow easy intravenous dosing or blood sampling.
Our technical staff and veterinarians also have a lot of experience in dosing via nonstandard routes e.g. topically to the eye, intraperitoneal, and rectal. If your product requires an alternative dosing route, please get in contact. We are always interested in setting up new methods in collaboration with our clients.
All general toxicology studies include daily clinical observation of the animals as well as food consumption and weekly recordings of body weight.
Furthermore, at Scantox we routinely perform ophthalmoscopy examination in all species as well as ECG (electro cardiography) in dog and minipig repeat dose toxicity studies.
The ECG investigations can be conducted either as standalone recordings or as JET (Jacketed External Telemetry). By using JET, the recordings are performed over a period of 22-24 hours, where the animal is housed in their home pen, which reduce stress and provide better data. In the general toxicity studies, we include clinical pathology, where we look at clinical chemistry, hematology and coagulation.
These parameters guide us to conclude on the effect a compound may have on different organ systems. All clinical pathology parameters are performed to meet worldwide guidelines.