Before conducting animal testing, toxicity study sponsors must get approval for toxicological studies by the testing organization’s Institutional Animal Care and Use Committee (IACUC). Single-dose or Acute toxicity studies monitor the effect of a single dose on an animal species. In acute toxicological study testing, we administer the investigational product at different doses and observe the results for ~14 days following a single dose. We perform non-GLP repeated dose toxicity studies in rodents (mice or rats) to identify maximum tolerated dose, target tissues, PK, and safety pharmacology profiles during late optimization and before the compound’s preclinical development and nonclinical toxicology assessment. If the test agent has reached a steady-state, and there is a reasonable or no accumulation of test article and no observed acute toxicity at therapeutic levels, then we follow-up with repeat-dose GLP toxicity studies. In repeated dose toxicity studies, the test drug is administered daily for a minimum of 7, 14, 21, or 28 days under GLP conditions. We can also perform subchronic toxicity studies in rodent and non-rodent models with daily dosing for 90 days or more.