On this episode of Molecular Moments, Dr. Jim McNally chats with DMPK Senior Director Dr. David Johnson, Ph.D., from BioAgilytix
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.
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).
The purpose of this study was to evaluate the Cardiac Injury Panel 2 Assay Kit, a multiplex 96-well electrochemiluminescent immunoassay from MSD for the determination of cTnI, cTnT, and fatty acid binding protein 3 (FABP 3) in rat serum.
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 biologic moves through the preclinical program, BioAgilytix is able to perform acute single dose toxicity testing to define and characterize its intrinsic toxicities, as well as generate data to establish acute exposure. 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.
Download this helpful resource to discover the 8 key selection criteria you should consider when evaluating a bioanalytical CRO to ensure a successful partnership.
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.