Peer-reviewed veterinary case report
Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies.
- Journal:
- Veterinary clinical pathology
- Year:
- 2005
- Authors:
- Boone, L et al.
- Affiliation:
- Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology · United States
Plain-English summary
This paper discusses recommendations from a group of veterinary experts on how to assess liver damage caused by drugs in both animals and humans. They have created guidelines based on the latest research to help ensure that liver-related test results are interpreted consistently and accurately. The goal is to better identify liver injury in studies before drugs are used in people. These recommendations aim to improve safety and understanding of potential liver issues linked to medications.
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.
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Search related cases →Original publication: https://pubmed.ncbi.nlm.nih.gov/16134065/