Preclinical toxicology investigates the adverse effects of test articles (e.g. drugs, toxins, and other agents) on various model systems to evaluate clinical risk.
Preclinical toxicology integrates many disciplines to investigate a compound’s safety profile, including genotoxicity, mutagenicity, repeat-dose cardiotoxicity, neurotoxicity, and general toxicology.
In the United States, toxicology studies are regulated by the US Food and Drug Administration (FDA) to ensure the safety of the population. The FDA requests the nonclinical data from single dose toxicity and repeat-dose toxicity studies to be submitted according to the SEND format (Standard for Exchange of Nonclinical Data).
emka TECHNOLOGIES toxicology solutions cover a wide range of experimental needs for exploratory and GLP toxicology programs based on in vitro, ex vivo, and in vivo models, in accordance with the FDA requirements.