Society of Toxicologic Pathology Position Paper on Best Practices on Recovery Studies

Autor: Charles W. Dean, Chuck Mahrt, Rick Perry, George L. Foley, Georgia Farris, Brian Short, Jean-Guy Bienvenu
Rok vydání: 2013
Předmět:
Zdroj: Toxicologic Pathology. 41:1159-1169
ISSN: 1533-1601
0192-6233
DOI: 10.1177/0192623313481513
Popis: 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.
Databáze: OpenAIRE