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Society of Toxicologic Pathology Position Paper on Best Practices on Recovery Studies: The Role of the Anatomic Pathologist

This article reviews the regulatory guidelines that provide for the inclusion of recovery groups in toxicology studies, presents the challenges in the design and interpretation of nonclinical recovery studies, and summarizes the best practices for the role of an anatomic pathologist regarding toxico...

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Published in:	Toxicologic pathology 2013-12, Vol.41 (8), p.1159-1169
Main Authors:	Perry, Rick, Farris, Georgia, Bienvenu, Jean-Guy, Dean, Charles, Foley, George, Mahrt, Chuck, Short, Brian
Format:	Article
Language:	English
Subjects:	Animals Biological and medical sciences Biopharmaceutics - standards Guidelines as Topic Medical sciences Pathology - methods Pathology - standards Research Design Toxicity Tests - methods Toxicity Tests - standards Toxicology Toxicology - methods Toxicology - standards
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container_title	Toxicologic pathology
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creator	Perry, Rick Farris, Georgia Bienvenu, Jean-Guy Dean, Charles Foley, George Mahrt, Chuck Short, Brian
description	This article reviews the regulatory guidelines that provide for the inclusion of recovery groups in toxicology studies, presents the challenges in the design and interpretation of nonclinical recovery studies, and summarizes the best practices for the role of an anatomic pathologist regarding toxicology studies with recovery groups. Evaluating the potential recovery of histopathologic findings induced by a biopharmaceutical requires the active participation of one or more anatomic pathologists. Their expertise is critical in risk assessment regarding the potential for recovery as well as providing scientific guidance in the design and evaluation of studies with recovery groups.
doi_str_mv	10.1177/0192623313481513
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subjects	Animals Biological and medical sciences Biopharmaceutics - standards Guidelines as Topic Medical sciences Pathology - methods Pathology - standards Research Design Toxicity Tests - methods Toxicity Tests - standards Toxicology Toxicology - methods Toxicology - standards
title	Society of Toxicologic Pathology Position Paper on Best Practices on Recovery Studies: The Role of the Anatomic Pathologist
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