Characterization of Procedure-Related Lesions at IV Injection Sites in Cynomolgus Macaques
Accurate interpretation of intravenous (IV) injection site pathology in non-human primates (NHPs) is essential for distinguishing background procedural changes from test article-related effects in preclinical toxicity studies. This retrospective analysis compiled microscopic findings from IV dose sites in 40 control Cynomolgus macaques across seven GLP-compliant studies. Common procedure-related changes included hemorrhage, neutrophilic infiltrate, and epidermal hyperplasia, while less frequent findings encompassed mixed or mononuclear cell infiltrates, granulation tissue, and fibroplasia. No definitive vascular lesions were identified. These findings reflect acute tissue trauma and early repair, emphasizing the need for toxicologic pathologists to recognize these common, non-specific responses when assessing potential injection site toxicity.
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