GLP Tox Release Testing, DS and Impurities

Prior to initiating clinical trial of any drug, it is mandatory to assess the drug for any possible toxic effect on biological tissues so that any harm in living subject can be identified. Pharmacological GLP toxicology studies are primarily performed to understand the onset, degree of severity, and time duration up to which a particular dose of a drug demonstrates any possible toxic effects. USFDA mandates that all Tox release testing must comply with GLP guidelines. Though both in vitro and in vivo testing is recommended, the manufacturer must undertake at-least in vitro testing before initiating the clinical trial phase.

At VIMTA, we offer testing service using a broad range of animal models and various routes of administration. Our state of the art facility is AAALAC certified, and our multi-disciplinary scientific team ensures that all tox studies are designed in a way that they have the potential to characterize the toxicity in human population.