VxP Pharma offers a complete range of toxicologic pathology laboratory services to support our pre-clinical studies and/or clinical trials. Our team of scientists includes toxicologists, pathologists, veterinary surgeons, regulatory specialists, and support personnel who have designed and performed safety programs ranging from acute through chronic toxicity. Our customized study designs enable our clients to quickly meet their product development goals and timelines, and in a cost conscious manner. We customize our in-vivo laboratory services to meet your unique objectives in a wide variety of animal models, to provide efficacy, pharmacokinetic, or toxicity data.
Acute toxicity describes the adverse effects of a substance which result either from a single exposure or from multiple exposures in a short period of time (less than 24 hours). To be described as acute toxicity, the adverse effects should occur within 14 days of the administration of the substance.
Our evaluation of acute toxicity data includes the relationship between the exposure of animals to the test article and the incidence and severity of all abnormalities, (including behavioral and clinical abnormalities), the reversibility of observed abnormalities, gross lesions, body weight changes, effects on mortality, clinical pathology, histopathology, and any other toxic effects as required by the client.
Our data from acute studies in rodent and non-rodents are used in conjunction with future repeat-dose data to aid in the determination of doses, routes, formulations, and regimens to be used in potential clinical studies. Non-GLP acute studies use a minimum number of animals and end-points and are intended to provide data used to make high-level project decisions with respect to more definitive studies.
We offer sub-chronic toxicity studies that are repeat-dose studies ranging from 5 days to 6 months.
Our clients use these study results to predict appropriate doses of the test article for more definitive repeat-dose studies, or chronic toxicity studies, and to help them determine the MTD and NOELs for selected toxicology endpoints including target organs.
Our study data from subchronic studies in rodent and non-rodents is used to aid in the determination of doses, routes, formulations, and regimens to be used in potential clinical studies. Non-GLP sub-chronic studies use a minimum number of animals and end-points and are intended to provide data used to make high-level project decisions with respect to more definitive studies.
Our chronic toxicity studies provide a thorough examination of the dose effect of a given article/substance on homeostasis, bodily function, induced diseases, and the effect on lifespan.
The study is conducted in rodent and non-rodent models 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 additional tests. 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 sub-chronic studies use a minimum number of animals and end-points and are intended to provide data used to make high-level project decisions with respect to the animal model chosen.
At VxP Pharma, we understand your needs and have extensive experience working with the FDA, USDA, and EPA required to make your animal research projects a success. Specifically tailored, individual study designs enable our clients to meet their product development goals and facilitate world-wide regulatory approval. Our individualized approach to each study allows us to revise and shift directions based on your changing needs.
Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.