Avigan Mark I
Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland.
Semin Liver Dis. 2014 May;34(2):215-26. doi: 10.1055/s-0034-1375961. Epub 2014 May 31.
The assessment of risk for serious, life-threatening drug-induced liver injury (DILI) associated with a suspect drug, biological agent, or herbal product depends on an iterative analysis of pre- and postmarket datastreams. Because serious cases of idiosyncratic DILI are typically rare, regulatory scientists seek strategies that accurately predict from clinical trial data which study drugs will be likely to cause these events in a large postmarket treatment population, e.g., through the identification of cases that are consistent with Hy's law. This objective is only achievable if rigorous standards in study subject monitoring, data collection and analysis of liver injury cases for causality are followed. In the future, the development of more effective predictive and analytic tools in preclinical and clinical testing will provide a framework to reliably identify new agents that have hepatotoxic profiles as well as those individuals who are susceptible to develop serious DILI.
对与可疑药物、生物制剂或草药产品相关的严重、危及生命的药物性肝损伤（DILI）风险评估，依赖于对上市前和上市后数据流的反复分析。由于特发性DILI的严重病例通常很少见，监管科学家们寻求能从临床试验数据中准确预测哪些研究药物在大量上市后治疗人群中可能导致这些事件的策略，例如，通过识别符合Hy法则的病例。只有遵循研究对象监测、肝损伤病例因果关系数据收集和分析的严格标准，这一目标才能实现。未来，在临床前和临床试验中开发更有效的预测和分析工具，将提供一个框架，以可靠地识别具有肝毒性特征的新药物，以及那些易发生严重DILI的个体。
