Compilation of international regulatory guidance documents for neuropathology assessment during nonclinical general toxicity and specialized neurotoxicity studies

Toxicol Pathol. 2011 Jan;39(1):92-6. doi: 10.1177/0192623310385145. Epub 2010 Nov 30.

Abstract

Neuropathology analyses as end points during nonclinical efficacy and toxicity studies are challenging and require 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 toxicologic neuropathology end points represents a set of criteria recommended for general toxicity studies and specialized neurotoxicity studies that should facilitate the efforts of individuals who plan, perform, analyze, and report neuropathology evaluations in nonclinical toxicity studies.

MeSH terms

  • Evaluation Studies as Topic
  • Government Agencies
  • Guidelines as Topic
  • International Cooperation / legislation & jurisprudence*
  • Internet
  • Nervous System Diseases / pathology*
  • Neurotoxicity Syndromes / pathology*
  • Societies, Scientific / legislation & jurisprudence
  • Toxicity Tests / standards*
  • United States