Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies
Selection and interpretation of clinical pathology indicators of hepatic injury in preclinical studies
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DOI：
10.1111/j.1939-165x.2005.tb00041.x
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发表时间：
2005-09-01
影响因子：
1.2
通讯作者：
Jordan, H
中科院分区：
文献类型：
--
作者：
Boone, L;Meyer, D;Jordan, H
本意见书描述了美国兽医临床病理学学会法规事务委员会关于使用临床前、临床病理学终点评估动物和人体药物性肝损伤潜力的专家建议。这些指南的制定基于相关临床前和人体临床试验文献中的当前建议;其旨在提供一种方法，用于对肝脏特异性数据进行一致和严格的解释，以识别临床前研究中的肝损伤和人类患者中肝损伤的潜在责任。
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.