In drug development, pre-clinical development is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data is collected.
The main goals of pre-clinical studies (also named preclinical studies and nonclinical studies) are to determine a product’s ultimate safety profile. Products may include new or iterated or like-kind medical devices, drugs, gene therapy solutions, etc. Each class of product may undergo different types of preclinical research. For instance, drugs may undergopharmacodynamics (PD), pharmacokinetics (PK), ADME, and toxicity testing through animal testing. This data allows researchers to allometrically estimate a safe starting dose of the drug for clinical trials in humans.