Booler, Helen, Lejeune, Typhaine, Sorden, Steve, Schafer, Kenneth, Short, Brian, Farman, Cindy, Ramos, Margaret, Bennett, Bindu, Krishna, Yekkala, Atzpodien, Elke-Astrid, Turner, Oliver, Brassard, Jaqueline, Gruebbel, Margarita and Foley, George (2021) Scientific and Regulatory Policy Committee Points to Consider*: Fixation, Trimming and Sectioning of Non-Rodent Eyes and Ocular Tissues for Examination in Ocular and General Toxicity Studies. Toxicologic pathology. ISSN 1533-1601; 0192-6233

Abstract

A Working Group of the Society of Toxicologic Pathology Scientific and Regulatory Policy Committee conducted a technical and scientific review of current practices relating to the fixation, trimming, and sectioning of the non-rodent eye, to identify key points and species-specific anatomical landmarks to consider when preparing and evaluating eyes of rabbits, dogs, minipigs and nonhuman primates from ocular and general toxicity studies. The topics addressed in this Points to Consider article include determination of situations when more comprehensive evaluation of the globe and/or associated periocular tissues should be implemented (expanded ocular sampling), and what constitutes expanded ocular sampling. In addition, this manuscript highlights the practical aspects of trimming and sectioning the eye to ensure adequate histopathological evaluation of all major ocular structures, including the cone-dense areas (visual streak/macula/fovea) of the retina for rabbits, dogs, minipigs and nonhuman primates, which is a regulatory expectation for ocular toxicity studies.

Item Type:	Article
Keywords:	Eye, retina, photoreceptors, toxicity studies, tissue fixation, area centralis, visual streak
Date Deposited:	02 Dec 2021 00:45
Last Modified:	02 Dec 2021 00:45
URI:	https://oak.novartis.com/id/eprint/44155