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Regulatory Toxicology

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. 

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 at Scantox. If needed, animals can be fitted with vascular catheters to allow easy intravenous dosing or blood sampling.

Technical staff and veterinarians at Scantox are also highly experienced in dosing via non-standard routes e.g. topically to the eye, intraperitoneal, and rectal. 

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Why Scantox 

  • IND enabling capabilities
  • All standard routes of administration
  • Dose preparation and dose formulation analysis is performed onsite
  • Histology and pathology is performed in-house
  • Safety Pharmacology Core battery – Rat Respiratory, Cardiovascular via implantable telemetry device or jacketed telemetry
  • Juvenile and Repro tox studies Segment 1 & 2
  • Small and large animal surgery onsite
  • SEND compliant
  • Best in Class “Animal Welfare” Program
  • Rapid study starts – 4 to 6 weeks from contract execution
  • On-time reporting – Audited Draft 8 to 10 weeks from end of in-life

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.

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Don’t hesitate to contact us should your product require an alternative dosing route.