Boone L, Meyer D, Cusick P, Ennulat D, Bolliger A Provencher, Everds N, Meador V, Elliott G, Honor D, Bounous D, Jordan H
Regulatory Affairs Committee of the American Society for Veterinary Clinical Pathology, USA.
Vet Clin Pathol. 2005 Sep;34(3):182-8. doi: 10.1111/j.1939-165x.2005.tb00041.x.
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.
本立场文件阐述了美国兽医临床病理学会监管事务委员会关于在评估药物诱导动物和人类肝损伤可能性时使用临床前、临床病理终点的专家建议。这些指南的制定基于相关临床前和人类临床试验文献中的当前建议；旨在提供一种方法，以便对肝脏特异性数据进行一致且严格的解读，从而在临床前研究中识别肝损伤，并确定人类患者肝损伤的潜在风险。
