Preclinical toxicology studies are a statutory requirement of drug development. Toxicity studies are used to characterize the toxicity profile of a drug by identifying its impact on organ structure and/or functionality. It provides vital information about long-term safety. This includes assessment of the severity and reversibility of toxicity, as well as dose ranges and their relationship to exposure. Ultimately, these toxicology studies aid in determining if, and to what degree, the biologic’s toxicity is dose-dependent, species-specific, mechanism-related and / or related to the method of administration. Our streamlined procedures and targeted reports allow us to offer credible data with operationally efficient services. Working with GVK BIO will enable you to incorporate the industry’s best practices into your drug testing program.
By understanding the injuries that could occur to kidneys, the heart, muscles, and other vital organs, toxicity studies help to determine the margin of safety of a drug for its expected dose. This information is key in guiding the parameters for trials to maximize safety and minimize risk. Not only do toxicological studies frame trial guidance related to duration, administration routes, and dose escalation, they also help to set the parameters for monitoring (i.e., which organs to assess closely). These strategies mitigate risks earlier and before a compound enters pre-clinical development. Importantly the information obtained can be rapidly used to engineer out toxicological liabilities and accelerate the route to the clinic.
GVK BIO performs general toxicology studies for the safety evaluation of pharmaceutical, biopharmaceutical, veterinary, chemical, agrochemical and consumer products. Through our toxicology studies, GVK BIO is able to help our clients characterize the potential extent of injury that a biologic could produce at varied dosages, and predict the consequences of such injury to understand the risk / benefit equation of the drug candidate in terms of toxicity and efficacy. We are able to conduct non-GLP toxicology studies, depending on customer needs and phase of development.
GVK Biosciences has an extensive track record in the design, performance and interpretation of pre-clinical investigative, mechanistic and exploratory/discovery toxicology programs. We offer a range of exploratory in vitro and in vivo preclinical safety and toxicity services. All our studies are conducted with IAEC approved protocols under supervision of trained veterinarians. Our rodent animal facility is accredited by AAALAC and NIH for ethical treatment of animals.
Our experience and expertise allows us to advise and conduct standard and novel toxicology study designs, as well as deal with unexpected findings or toxicity issues during the course of a program.
Our studies are designed and run by seasoned experts. Services include:
- Pharmacokinetic & pharmacodynamic drug testing (PK/PD Testing)
- Pharmacodynamic modeling for candidate selection, safety evaluation and patient dosing strategies
We can also:
- Identify appropriate dosing routes
- Conduct dose range finding studies
- Perform studies to establish the maximum tolerated dose