Journal of Immunotoxicology. 2010;7(2):77-78
Abstract: Non-human primates (NHP), particularly macaques, are commonly used in studies conducted to assess toxicity of new pharmaceutical entities. NHP harbor a variety of pathogenic and potentially opportunistic infectious organisms, which may result in overt infectious disease during the course of a study, complicating interpretation of study findings, particularly when the pharmaceutical entity under evaluation is intended to be immunomodulatory. Clinical infection occurring on a toxicology study may be useful in identifying an effect on host resistance; however, the spontaneous occurrence of infection may inappropriately suggest a test article effect. In addition, background infection may present an animal welfare or zoonotic concern. Researchers and suppliers of NHP utilize a wide variety of screening and preventive care measures as well as approaches to overt infections seen during the course of a study. A Workshop was held to bring together key stakeholders for a discussion of these issues and the various practices employed to address them. The Workshop was sponsored by the Immunotoxicology Technical Committee (ITC) of the Health and Environmental Sciences Institute (HESI) of the International Life Sciences Institute (ILSI).
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