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Compilation of International Regulatory Guidance Documents for Neuropathology Assessment during Nonclinical Toxicity Studies
Citation:
Bolon, B., M. Butt, K. F. JENSEN, G. Krinke, D. R. Mellon, AND A. Bradley. Compilation of International Regulatory Guidance Documents for Neuropathology Assessment during Nonclinical Toxicity Studies. TOXICOLOGIC PATHOLOGY. Society of Toxicology, RESTON, VA, 39(1):92-96, (2011).
Impact/Purpose:
EPA's neuropathology testing guidelines sets the standard for neuropathologic assessments for nonclinical toxicity studies. Neuropathology as an endpoint during nonclinical efficacy and toxicity studies is challenging and a variety of regulatory agencies have developed guidelines to facilitate this process. A comparison of such guidelines from a variety of national and international agencies demonstrates EPA's guidance has set the standard against which others are measured
Description:
Neuropathology analysis as an endpoint during nonclinical efficacy and toxicity studies is a challenging prospect that requires trained personnel and particular equipment to achieve optimal results. Accordingly, many regulatory agencies have produced explicit guidelines for designing and performing neuropathology assessments for nonclinical studies. This compilation of international regulatory guidance for the toxicologic neuropathology endpoints that are recommended for general toxicity studies and specialized neurotoxicity studies should facilitate the efforts of individuals who plan, perform, analyze, and report neuropathology evaluations in nonclinical toxicity studies.
