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.

journal_name

Toxicol Pathol

journal_title

Toxicologic pathology

authors

Seaton M

doi

10.1177/0192623313506878

subject

Has Abstract

pub_date

2014-01-01 00:00:00

pages

285

issue

1

eissn

0192-6233

issn

1533-1601

pii

0192623313506878

journal_volume

42

pub_type

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