title: The study pathologist's role in GLP studies: a regulator's perspective.
abstract: Results of early nonclinical "General Toxicology" studies are used to set a safe starting dose for first-in-human (FIH) clinical trials. In FIH trials, the research subjects are typically healthy volunteers who have little to gain but much to lose if a trial goes wrong. With that in mind, good laboratory practice regulations require that a standardized system be used for the conduct, documentation, and retention of study-related materials. The study pathologist, working within that system of standards, documentation, and oversight, is key to the identification of potential target organs of toxicity and other toxicologically significant findings.
authors.affiliation: 1Division of Antiviral Drug Products, FDA/CDER, Silver Spring, Maryland, USA.
authors.forename: Mark
authors.initials: M
authors.lastname: Seaton
mesh_terms: D004353:Drug Evaluation, Preclinical; D010336:Pathology / Q000592:standards*; D012107:Research Design; D018675:Toxicity Tests; D014116:Toxicology
keywords: preclinical safety-assessment/risk management; regulatory affairs; safety assessment.