美国FDA药物肝毒性监测和管理文件简析

药物是造成肝损害的重要原因之一。目前，对药物肝毒性进行科学监测和管理是制药企业和药品监管部门面临的一项具有挑战性的任务，对新药研发、临床诊断和治疗以及药品上市后监管都有重要的意义。通过介绍美国FDA、美国药物研究与制药商协会（PbRMA）、美国肝病协会（AASLD）共同制定的关于药物肝毒性监测和管理的文件，为读者提供了关于药物肝毒性的探测、评价和管理的许多有价值的信息；通过简析这些文件，以期为我国药物肝毒性的监测和管理提供重要的借鉴作用。

Analysis of drug-induced hepatotoxicity and FDA white papers

Drug-induced hepatotoxicity is the most frequent cause of liver injury. The economic burden of liver injury is substantial for our society. The risk of hepatotoxicity is a long standing problem and a major challenge for pharmaceutical industry and regulatory agency. We reviewed the FDA-PhRMA-AASLD's drug-induced hepatot- oxicity white papers and discussed the implication for drug development and regulatory policy. These white papers provided rich information about detection, evaluation and management of drug-induced hepatotoxicity. Discussions in this paper could be considered for future improvement of Chinese regulatory policy related to hepatotoxicity.