Otsuka PDC, Rockville, Maryland, USA.
US Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther. 2020 Feb;107(2):333-346. doi: 10.1002/cpt.1571. Epub 2019 Sep 14.
The diagnosis and management of drug-induced liver injury (DILI) remains a challenge in clinical trials in drug development. The qualification of emerging biomarkers capable of predicting DILI soon after the initiation of treatment, differentiating DILI from underlying liver disease, identifying the causal entity, and assigning appropriate treatment options after DILI is diagnosed are needed. Qualification efforts have been hindered by lack of properly stored and consented biospecimens that are linked to clinical data relevant to a specific context of use. Recommendations are made for biospecimen collection procedures, with the focus on clinical trials, and for specific emerging biomarkers to focus qualification efforts.
药物性肝损伤（DILI）的诊断和管理在药物开发的临床试验中仍然是一个挑战。需要有能力预测治疗开始后不久发生的 DILI、区分 DILI 与潜在肝病、识别因果实体以及在诊断出 DILI 后选择适当治疗方案的新兴生物标志物。由于缺乏与特定使用情况相关的临床数据相关联的妥善保存和同意的生物标本，因此阻碍了资格认证工作。针对生物标本采集程序提出了建议，重点是临床试验，并针对特定的新兴生物标志物集中进行资格认证工作。
