Guidance for the clinical evaluation of traditional Chinese medicine-induced liver injury Issued by China Food and Drug Administration

• 来源期刊: 药学学报（英文版）
• 年，卷（期）: 2019,（3）
• 页码范围: 648-658
• 页数: 11页
• 语种: 英文

摘要

1.Introduction Drug-induced liver injury (DILI),defined as liver injury caused by a drug and/or its metabolites,is a common clinical adverse drug reaction1-4.This type of injury can cause acute liver failure and even death in severe cases5.DILI accounts for many drug warnings and is an important cause of failure in the clinical development of new drugs and new forms of traditional Chinese medicine (TCM).Thus,liver injury from drugs has attracted close attention from medical professionals,the pharmaceutical industry,and the general public6-8.