title: Society of Toxicologic Pathology position paper on best practices on recovery studies: the role of the anatomic pathologist.
abstract: 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.
authors.affiliation: 1Pfizer, Groton, Connecticut, USA.
authors.forename: Rick
authors.initials: R
authors.lastname: Perry
authors.forename: Georgia
authors.initials: G
authors.lastname: Farris
authors.forename: Jean-Guy
authors.initials: JG
authors.lastname: Bienvenu
authors.forename: Charles
authors.initials: C
authors.lastname: Dean
authors.forename: George
authors.initials: G
authors.lastname: Foley
authors.forename: Chuck
authors.initials: C
authors.lastname: Mahrt
authors.forename: Brian
authors.initials: B
authors.lastname: Short
mesh_terms: D000818:Animals; D001702:Biopharmaceutics / Q000592:standards; D017408:Guidelines as Topic; D010336:Pathology / Q000379:methods / Q000592:standards; D012107:Research Design; D018675:Toxicity Tests / Q000379:methods / Q000592:standards; D014116:Toxicology / Q000379:methods / Q000592:standards
keywords: ICH M3 (R2); ICH S6; ICH S9.; best practices; recovery studies; reversibility