The purpose of the general toxicology studies is to ensure that only drug candidates with a good safety profile are selected for human trials. With over 40 years of experience Scantox has a long track record of successfully conducting toxicology studies. The studies are performed in several species, including rodents and non-rodents.
Scantox offers general toxicology studies in both rodents and a non-rodents, and all our technical staff are highly experienced and experts in handling and dosing of animals. Within the field of minipig toxicology we are globally considered the leading expert.
Toxicology studies are typically performed in two species – one rodent and one non-rodent. Initial studies are performed as a stepwise process fashion, starting with a Maximum Tolerated Dose (MTD) study, followed by a Dose Range Finding (DRF) study. The MTD and DRF studies are performed to set the appropriate dose levels, as well as supplement the choice of 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 4-week toxicity studies are typically performed.
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.
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 are also highly experienced in dosing via non-standard routes e.g. topically to the eye, intraperitoneal, and rectal. Don’t hesitate to contact us should your product require an alternative dosing route.
All general toxicology studies include daily clinical observation of the animals as well as food consumption and weekly recordings of body weight.
We routinely perform ophthalmoscopy examination in all species as well as ECG (electro cardiography) 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.
At the end of general toxicology studies, a histopathological evaluation is performed to investigate potential organ changes following e.g. daily dosing for a longer period. The histopathological evaluation is done on all species and is performed on site by our experienced histology technicians and pathologists. During general toxicology studies we can analyze the dose formulations used to confirm that the animals receive the expected doses. Dose formulation analysis can be performed on our GLP-validated HPLC.
As a part of general toxicology studies blood samples are collected from the animals to investigate the systemic exposure of the compounds. The Scantox scientists working in the bioanalytical laboratory can analyze the collected toxicokinetic samples on a LC-MS/MS and provide you with a toxicokinetic evaluation of the obtained data.
During general toxicology studies we can analyze the dose formulations used to confirm that the animals receive the expected doses. Dose formulation analysis is performed on a GLP-validated HPLC.
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