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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Bibliographic Details
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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Summary: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.
ISSN:0192-6233
1533-1601
DOI:10.1177/0192623313481513