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
Safety and Toxicology Evaluation
- Tail suspension test in mice
- Spontaneous locomotor activity measurement in rats
- Rotorod testing in rats and mice
- Mini Ames/Complete Ames
- Mouse Lymphoma Assay
- Chromosomal Aberration
- Micronucleus Test
Exploratory Toxicity studies
- Acute toxicity/maximum tolerated dose (MTD)
- Repeat dose 7-90 Days Toxicity studies
- Toxicokinetic studies (TK)
- Histopathology (with a partner)
Expertise of GVK BIO in Toxicology Studies
Choosing a lead compound from the pool of candidates does not need to be so time consuming or costly. Whether you are in the exploratory candidate selection stage in pharmaceuticals or agrochemicals, efficient use of exploratory testing services can be your simple answer to a challenging decision. GVK BIO’s scientific team has extensive experience conducting toxicology evaluation studies, using enzymatic assays and immunoassays to support kidney, cardiac, and muscle injury in a variety of matrices, including serum, plasma, and urine. At GVK BIO, our experienced and skilled teams have access to the latest technology that can make a difference to our clients by designing time- and cost-effective strategies for early toxicology assessment of a compound or compound series. In fact, half of our scientists have over 10 years of experience performing non-GLP toxicology studies.
The risk assessment done using toxicology evaluation studies is vital to characterize potential adverse effects that may occur, and to estimate a safe starting dose and dosage regimen as guidance for steps in Drug Discovery. GVK BIO will conduct both standard and customized toxicology studies to meet your safety assessment needs as well as your regulatory requirements.
These programs are typically intended to identify the toxicological mode of action (MOA)/adverse outcome pathway (AOP) affected by the compound in question. We establish custom in vitro and in vivo models to answer specific toxicological questions.
We also offer exploratory and discovery toxicology services to characterize potential (for example on-target) or observed toxicity issues. Through an understanding of mechanistic toxicology at the early research stage, we can generate information that informs molecule design, candidate selection and translational risk assessment.
If required we can build and deploy novel in vitro mechanistic assays for screening of candidate compounds to provide comparative data on toxicological risk. This data can be used to drive further chemistry. Our experience in this area spans the agrochemical, chemical, consumer products and pharmaceutical industries.
At GVK BIO, we are here to collaborate with you and guide you through the most appropriate studies and study designs so that you can make informed decisions quickly and at reduced cost. We have experts in all necessary disciplines including regulatory affairs, and our experienced program managers offer you proactive guidance and dedicated responsiveness to support your candidate comparison program.