This article needs additional citations for verification. Please help improve this article by adding citations to reliable sources. Unsourced material may be challenged preclinical toxicity studies pdf removed. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product’s safety profile.
Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools. On average, only one in every 5,000 compounds that enters drug discovery to the stage of preclinical development becomes an approved drug.
Each class of product may undergo different types of preclinical research. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans. Some medical devices will also undergo biocompatibility testing which helps to show whether a component of the device or all components are sustainable in a living model. Drug Administration in the United States.
Typically, both in vitro and in vivo tests will be performed. Studies of a drug’s toxicity include which organs are targeted by that drug, as well as if there are any long-term carcinogenic effects or toxic effects on mammalian reproduction.
The information collected from these studies is vital so that safe human testing can begin. Typically, in drug development studies animal testing involves two species.