Nonclinical Toxicology (tox) Studies evaluate drug exposure for adverse effects and therapeutic index during preclinical development. FDA requires toxicological studies in a minimum of two animal species before first in human (FIH) dosing. Generally, one of the selected species for in vivo toxicology studies may be rodent and the other must be non-rodent. Toxicology studies span various designs, including single or acute dose toxicity study, dose range finding (DRF) study, maximum tolerated dose (MTD) study, and repeated dose toxicity studies. We conduct regulated nonclinical tox studies using Good Laboratory Practices (GLP) under 21 CFR part 58. Our toxicology services include routine GLP toxicokinetic (TK) studies and Non-Compartmental Analysis for dose ranging studies. Toxicokinetic (TK) study helps quantitate the systemic exposure time course for prodrugs, drugs, and metabolites. NorthEast BioLab delivers rapid and high-quality non-GLP and GLP toxicity studies to assess your therapeutic compound. Ultimately, acceptable drug safety during tox studies allows FIH testing as your crucial nonclinical toxicology data informs clinical toxicological analysis.
Toxicological or Toxicology (tox) Studies help determine drug safety by evaluating adverse effect profiles, organ and tissue exposures, and margins of efficacy vs. toxicity. Indeed, these toxicology studies in drug development often range doses encompassing the therapeutic index, defining the window between minimum efficacious and maximum tolerated (or feasible) doses. Typically, test articles selected for nonclinical toxicology assessment are optimized drug discovery leads evaluated previously for pharmacokinetics, potency, and efficacy in preclinical disease models. This preliminary data collection is often essential for designing initial toxicology studies, especially for selecting dose levels, routes, and regimens. Tox studies usually begin with dose range-finding (DRF), maximum tolerated dose (MTD), and single ascending dose or short-term (7-day) repeat dose nonclinical toxicology studies. The purpose of these toxicity studies is to ascertain an appropriate dosing regimen for the long term (≥28-day) repeat dose GLP toxicity study. Generally, the repeat dose studies encompass the drug effects on the entire body utilizing various toxicology services such as gross pathology, histology, and microscopy. Furthermore, additional focused studies are performed to evaluate safety on particular organ systems or anticipated risk factors.