Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies
Boone, L; Meyer, D; Cusick, P; Ennulat, D; Bolliger, AP; Everds, N; Meador, V; Elliott, G; Honor, D; Bounous, D; Jordan, H
HERO ID
782862
Reference Type
Journal Article
Subtype
Review
Year
2005
Language
English
PMID
| HERO ID | 782862 |
|---|---|
| Material Type | Review |
| In Press | No |
| Year | 2005 |
| Title | Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies |
| Authors | Boone, L; Meyer, D; Cusick, P; Ennulat, D; Bolliger, AP; Everds, N; Meador, V; Elliott, G; Honor, D; Bounous, D; Jordan, H |
| Journal | Veterinary Clinical Pathology |
| Volume | 34 |
| Issue | 3 |
| Page Numbers | 182-188 |
| 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. |
| Doi | 10.1111/j.1939-165X.2005.tb00041.x |
| Pmid | 16134065 |
| Wosid | WOS:000231634700006 |
| Is Certified Translation | No |
| Dupe Override | No |
| Is Public | Yes |
| Language Text | English |
| Keyword | ALT; hepatic injury; hepatotoxicity; liver; preclinical safety assessment |
| Is Peer Review | Yes |
| Relationship(s) |
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