Delivering Accurate, Rapid Insights into Safe Dosing Regimens
Through our toxicology studies, BioAgilytix 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 both non-GLP and GLP toxicology studies, depending on customer needs and phase of development.
Find Answers To Your Toxicology Assay Questions
Toxicology Studies: Critical to Assessing Biologic Safety
Toxicology studies are used to characterize the toxicity profile of a drug by identifying its impact on organ structure and / or functionality. 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.
By understanding the injuries that could occur to kidneys, the heart, muscles, and other vital organs, toxicology studies help to determine the margin of safety of a drug for its expected clinical dose. This information is key in guiding the parameters for clinical trials to maximize safety and minimize risk. Not only do toxicology studies frame trial guidance related to duration, administration routes, and dose escalation, they also help to set the parameters for clinical monitoring (i.e., which organs to assess closely).
Bioagilytix Toxicology Services: From Discovery to Regulated Studies
BioAgilytix conducts both non-GLP and GLP toxicology studies, depending on customer needs and phase of drug development. We can assist early in the drug development process to assess the probability of success for the novel compound in question, providing insight into potential toxicity concerns before significant time and cost are invested. This helps to ensure our clients can anticipate and respond to toxicology-related challenges sooner, and prioritize the most promising compounds for advancement.
As the therapeutic moves through the preclinical program, BioAgilytix is able to generate data to establish drug exposure levels. This information is paired with dose range finding assessments, which are critical to understanding human risk. By measuring the impact at low, high, and intermediate doses, our team can demonstrate the no observed adverse effect level (NOAEL), which determines the highest dosage level at which chronic exposure to the substance shows no adverse effects, and the no observed effect level (NOEL), which reveals the dose-response relationship. GLP-compliant toxicology studies are mandatory to provide data to regulatory authorities when requesting permission to commence human clinical trials, and BioAgilytix is a GLP/GMP bioanalytical laboratory fully adhering to all GLP procedural standards, principles, and processes.
Extensive Platform Options to Meet Your Toxicity Testing Requirements
Leveraging a suite of advanced platforms, BioAgilytix can perform highly sensitive bioanalysis using a very small volume of sample, while yielding greater throughput, better reproducibility, and less variability.
We also offer validated biomarker assays to help streamline the time and cost of drug development. In fact, we have developed an extensive menu of over 100 validated biomarker assays, many for toxicology testing. Our toxicology studies are designed to yield robust, accurate results with rapid turnaround.
Your Project Will Benefit From Specialized Toxicology Expertise
BioAgilytix’s scientific team has extensive experience conducting toxicology studies, using enzymatic assays and immunoassays to support kidney, cardiac, and muscle injury in a variety of matrices, including serum, plasma, and urine. In fact, over half of our scientists boast over 15 years of experience performing both non-GLP toxicology studies and GLP toxicology studies in full compliance with GLP regulations.
The risk assessment done using toxicology studies is vital to characterize potential adverse effects that may occur, and to estimate a safe starting dose and dosage regimen as guidance for clinical trials. BioAgilytix will conduct both standard and customized toxicology studies to meet your safety assessment needs as well as your regulatory requirements.
Leverage the expertise of BioAgilytix’s veteran team to deliver robust toxicity testing results with streamlined turnaround.
Our Toxicology Expertise Includes:
- Kidney Injury Panel
- Cardiac Injury Panel
- Muscle Injury Panel
- Enzymatic Assays
- Single and Multiplex Support