Delivering Accurate, Rapid Insights into Safe Dosing Regimens
A major component of preclinical testing of investigative therapeutics is the successful completion of GLP toxicology studies in appropriate and relevant animal models. BioAgilytix works together with our sponsors and their selected in-life study facilities to provide critical bioanalytical testing of GLP toxicology samples.
Key bioanalytical assays for toxicology studies
Toxicology studies are a critical aspect of in vivo testing during the preclinical stage designed to determine the safety profile of investigative therapeutics through defining the relationship between administered dose and any drug-related adverse effects. BioAgilytix routinely performs analysis of non-GLP and GLP toxicology study samples across a variety of endpoints such as:
- Pharmacokinetics/Toxicokinetics
- Dose Formulation Analysis
- Humoral Immunogenicity (ADA and NAb)
- Cellular Immunogenicity (ELISpot and Flow Cytometry)
- Biomarkers
- Multiplex Cytokine Panels
Our biomarker assay solutions
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. These assays are designed to yield robust, accurate results with rapid turnaround.
BioAgilytix’s diverse expertise with preclinical programs
Our scientists have extensive expertise across a wide range of therapeutic modalities and animal species including but not limited to rodent, canine, nonhuman primate, and minipig. We also have experience supporting a wide range of large and small molecule modalities across many different therapeutic focus areas. At BioAgilytix, we know that each toxicology program presents unique challenges and tailor our analytical solutions to provide the most appropriate assay services to provide quick, accurate results to our clients.
POSTER PRESENTATION
Evaluation of the MSD Multiplex Electrochemiluminescent Immunoassy for the Determination of Cardiac Toxicity Biomarkers in Rat Serum
Learn more about the analytical testing services we’ve provided to our clients for their toxicology studies