Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies
- 1 September 2005
- journal article
- review article
- Published by Wiley in Veterinary Clinical Pathology
- Vol. 34 (3) , 182-188
- https://doi.org/10.1111/j.1939-165x.2005.tb00041.x
Abstract
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.Keywords
This publication has 30 references indexed in Scilit:
- Alpha-Glutathione S-Transferase in the Assessment of Hepatotoxicity—Its Diagnostic Utility in Comparison with Other Recognized Markers in the Wistar Han RatToxicologic Pathology, 2002
- Use of Biomarkers and Surrogate Endpoints in Drug Development and Regulatory Decision Making: Criteria, Validation, StrategiesAnnual Review of Pharmacology and Toxicology, 2001
- Drug-Induced Liver DisordersDrug Safety, 2001
- Harmonization of Animal Clinical Pathology Testing in Toxicity and Safety Studies*Fundamental and Applied Toxicology, 1996
- Frequency and relationships of clinical chemistry and liver and kidney histopathology findings in 13-week toxicity studies in ratsToxicology, 1996
- Hematological Effects of 2',3'-Dideoxycytidine in RabbitsToxicologic Pathology, 1992
- Correlation of changes in serum analytes and hepatic histopathology in rats exposed to carbon tetrachlorideToxicology Letters, 1991
- Criteria of drug-induced liver disordersJournal of Hepatology, 1990
- The Effects of Four Types of Restraint on Serum Alanine Aminotransferase and Aspartate Aminotransferase in the Macaca fascicularisJournal of the American College of Toxicology, 1990
- Increased Serum Alanine Aminotransferase Activity Associated With Muscle Necrosis in the DogJournal of Veterinary Internal Medicine, 1990