Regulatory Perspectives on Juvenile Animal Toxicologic Pathology. (December 2021)

• Record Type: Journal Article
• Authors: Rao, Deepa B.; Hoberman, Alan M.; Brown, Paul C.; Varela, Aurore; Bolon, Brad
• Other Names: Benoit-Biancamano Marie-Odile guest-editor.; Halpern Wendy guest-editor.; Parker George guest-editor.
• Is Part Of: Toxicologic pathology. Volume 49:Number 8(2021)
• Page Start: 1393
• Page End: 1404
• Publication Date: 2021-12
• Subjects: juvenile animal study -- ICH S11 -- developmental neurotoxicity -- neuropathology -- neurotoxicity -- developmental toxicity -- bone assessments; Pathology -- Periodicals; Toxicology -- Periodicals; Pathology; Toxicology; 615.9
• DOI: 10.1177/01926233211046869
• Languages: English
• ISSNs: 0192-6233

Abstract

The Society of Toxicologic Pathology's Annual Virtual Symposium (2021) included a session on "Regulatory Perspectives on Juvenile Animal Toxicologic Pathology." The following narrative summarizes the key concepts from the four talks included in this symposium session chaired by Drs Deepa Rao and Alan Hoberman. These encompass an overview of various global regulations impacting the conduct of juvenile animal studies in pharmaceutical drug development and chemical toxicity assessments in a talk by Dr Alan Hoberman. Given the numerous regulatory guidances and legal statutes that have covered the conduct of juvenile animal studies and the recent harmonization of these guidances for pharmaceuticals, Dr Paul Brown provided an update on the harmonization of these guidances for pharmaceuticals, in the recently finalized version of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use S11 guidance document, "Nonclinical Safety Testing in Support of Development of Pediatric Medicines." The first two talks on regulations were followed by two talks focused on an evaluation of the postnatal development of two major organ systems relevant in juvenile animals. Dr Aurore Varela covered study design and endpoints impacting the skeletal system (bone), while Dr Brad Bolon presented a talk on the study design and conduct of neuropathology evaluations for the developing nervous system.