Along with existing discovery phase pharmacokinetic and efficacy data, Aragen’s DABT board-certified toxicologists utilize data from non-GLP acute and dose range finding studies to optimize the dosing regimen for GLP repeat-dose toxicology and safety studies. These non-GLP staging studies are of the utmost importance to identify the toxic threshold of a test article leading into designing pivotal GLP studies.
A bioanalytical method is the basis by which any correlation of adverse effects to test articles can be assessed. Our skilled bioanalytical team will develop, optimize and validate all bioanalytical methods for each species and matrices from discovery through development whether an industrial chemical, a drug, a vaccine or a plant-extract based biostimulant.
Services for Pharmaceutical and Biotechnology Industries
Analytical/Bioanalytical Method Development and Validation
Pharmacokinetics/Toxicokinetics
nonGLP Dose Range Finding Studies
IND-Enabling GLP Toxicology & Safety
NDA/BLA-Enabling GLP Toxicology & Safety
Nonclinical and Clinical Bioanalysis
Services for Chemical and Agrochemical Industries
Analytical/Bioanalytical Method Development and Validation