Official websites use. Share sensitive information only on official, secure websites. The purpose of this publication is to provide a standardized nomenclature for classifying microscopic lesions observed in most tissues and organs from the nonhuman primate used in nonclinical safety studies. Some of the lesions are illustrated by color photomicrographs.
Sources of material included histopathology databases from government, academia, and industrial laboratories throughout the world. Content includes spontaneous lesions as well as lesions induced by exposure to test materials. Relevant infectious and parasitic lesions are included as well. A widely accepted and utilized international harmonization of nomenclature for lesions in laboratory animals will provide a common language among regulatory and scientific research organizations in different countries and increase and enrich international exchanges of information among toxicologists and pathologists.
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Keywords: nonhuman primate, pathology, toxicopathology, nomenclature, background findings, INHAND, cynomolgus macaque. Members of the Societies of Toxicologic Pathology had the opportunity to comment on the draft version during a day period. The initial series of nomenclature publications were focused on findings in rats and mice. Although the INHAND nomenclature and diagnostic criteria represent a preferred international standard nomenclature for lesions identified in nonclinical studies, recommendations for diagnostic criteria and preferred terminology may not be applicable in all situations.
The purpose of specific experiments or the specific context of a given study may require modifications to this standardized nomenclature and diagnostic criteria. The appropriate diagnoses are ultimately based upon on the scientific judgement of the study pathologist. The present publication provides standardized terms and diagnostic criteria for histopathology observations to be used in nonclinical toxicology studies conducted in cynomolgus monkeys Macaca fascicularis.
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Throughout this publication, findings applicable for use in general toxicology studies in monkeys are tabulated by organ system. In most instances, the description and definition of the rodent finding applies to the monkey and is not further described.
