For several decades CARE’s exceptional team of scientists including toxicologists, pathologists, veterinary surgeons, regulatory specialists, and support personnel has designed and performed safety programs ranging from acute through chronic toxicity.
Our chronic toxicity studies provide a thorough examination of the dose effect of a given substance on homeostasis, bodily function, induced diseases, and the effect on lifespan. These provide the bulk of the preclinical information used for assessing safety and risk.
The study is conducted in rodent and non-rodent models, in both sexes, and over a regimen that approaches the lifespan of the animal. There are often multiple intermediate evaluations, including daily observations, weekly food and water consumption, and body weight determinations, pharmacokinetic satellite plasma collection, interim necropsies, clinical pathology, and more. At the termination of the study all animals are subjected clinical pathology and to a full necropsy with full tissue collection followed by histopathology.
We recommend group sizes in GLP studies sufficient in number to assure enough animals survive to provide statistical significant data. Non-GLP chronic studies use a minimum number of animals and end-points and are intended to provide data used to make a go/no-go decision with respect to the GLP chronic study in the animal model chosen. In some cases a chronic study could provide data needed to evaluate the cancer potential of a certain substance and is usually designed to mimic the route of human exposure.
Species available include mice, rats, rabbits, canine, and poultry.