Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies

This position paper delineates the expert recommendations of the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology for the use of preclinical, clinical pathology endpoints in assessment of the potential for drug-induced hepatic injury in animals and humans. Devel...

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Bibliographic Details
Published in:Veterinary clinical pathology 2005-09, Vol.34 (3), p.182-188
Main Authors: Boone, L, Meyer, D, Cusick, P, Ennulat, D, Bolliger, A.P, Everds, N, Meador, V, Elliott, G, Honor, D, Bounous, D
Format: Article
Language:English
Subjects:
adverse effects
ALT
animal models
animal pathology
Animals
bioassays
biomarkers
clinical examination
Disease Models, Animal
dogs
drug abuse
drug toxicity
drugs
guidelines
hepatic injury
hepatotoxicity
human health
literature reviews
liver
Liver - injuries
Liver - pathology
Liver Function Tests
Pathology - education
preclinical safety assessment
Primates
rats
Safety
symptoms
Veterinary Medicine - trends
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Summary:This position paper delineates the expert recommendations of the Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology for the use of preclinical, clinical pathology endpoints in assessment of the potential for drug-induced hepatic injury in animals and humans. Development of these guidelines has been based on current recommendations in the relevant preclinical and human clinical trial literature; they are intended to provide a method for consistent and rigorous interpretation of liver-specific data for the identification of hepatic injury in preclinical studies and potential liability for hepatic injury in human patients.
ISSN:0275-6382
1939-165X
DOI:10.1111/j.1939-165X.2005.tb00041.x