Compilation of international regulatory guidance documents for neuropathology assessment during nonclinical general toxicity and specialized neurotoxicity studies.
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.
GEMpath Inc., 2867 Humboldt Cir., Longmont, CO 80503-2339, USA. brad@gempath.net
Brad
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Bolon
Alys
A
Bradley
Mark
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Butt
Karl
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Jensen
Georg
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Krinke
R Daniel
RD
Mellon
D005069:Evaluation Studies as Topic; D006077:Government Agencies; D017408:Guidelines as Topic; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D020407:Internet; D009422:Nervous System Diseases / Q000473:pathology*; D020258:Neurotoxicity Syndromes / Q000473:pathology*; D012958:Societies, Scientific / Q000331:legislation & jurisprudence; D018675:Toxicity Tests / Q000592:standards*; D014481:United States