Exploratory non-GLP toxicology –
an integrated part of drug discovery.
Eploratory toxicology studies may be the first to be performed on a new candidate drug that has never been investigated in-vivo before. Also, exploratory toxicology has been moved into the early phases of the R&D chain to prevent drug candidates with a safety risk from entering later stages of development.
Scantox offers explorative toxicology studies to help clients early in the development process to identify and define preclinical efficacy and tolerability. In addition, screening studies can be performed to quickly and cost effectively identify which compounds are unlikely to succeed in further preclinical development.
Explorative preclinical toxicology studies are intended to assess the pharmacological potential of new candidates, the onset of toxic effects and potential dose dependency. They can encompass dosing regimens from a single dose to multiple doses. Several routes of exposure (e.g., oral, intravenous, intramuscular, intranasal, intratracheal, subcutaneous, topical, etc.) can be accomodated and Scantox offers a wide range of disease models, including efficacy models with infectious agents at biosafety levels 2 and 3 (BSL2 and BSL3). Multiple species (rodents – non-rodents) are available.
Scantox are specialists in the conduct of comparative studies in which several compounds are administered to small numbers of animals and limited toxicological assessments are carried out. These studies give an idea of relative toxicity and effect and facilitate selection of one or two candidates for further investigation.
Studies are customized to the individual client based on a range of study types:
- Acute single dose toxicity
- Local tolerance
- Implant tolerance
- Other customized studies
Various traditional administration routes are supported, including, SC, IP, PO, IV, and topical administration but we also perform more complex administration techniques, including:
- Respiratory, including intranasal and intratracheal
- Urinary tract and vaginal instillation
- Intravitreal administration
- Stereotactic brain injection
A full complement of toxicology evaluations is available in-house. These evaluations include clinical chemistry, hematology, coagulation, urinalysis, histopathology, bioanalysis and toxicokinetics.
Clients are always invited to visit Scantox and to be present during the study. It is our experience that in the early exploratory stages of drug and medical device development the client and the Scantox team mutually benefit from such close collaboration.