【PearSOUR:))Cc】評論

（X）(A) 符合Hy's Law的定義→Hy's Law用於預估急性藥物導致之肝細胞型肝傷害（可能伴隨黃疸）

【HUSpiTLE】評論

Hy’s Law: 用來識別某藥物是否可能造成嚴重的肝細胞型肝損傷。The drug causes hepatocellular injury, generally shown by a higher incidence of 3-fold or greater elevations above the ULN of ALT or AST than the (nonhepatotoxic) control drug or placebo(ALT, AST比正常值高出3倍以上)Among trial subjects showing such AT (aminotransferase) elevations, often with ATs much greater than 3xULN, one or more also show elevation of serum TBL(total bilirubin) to >2xULN, without initial findings of cholestasis (elevated serum ALP) (Aminotransferase上升3倍以上或total bilirubin上升2倍以上，但尚未出現膽汁鬱積)No other reason can be found to explain the combination of increased AT and TBL, such as viral hepatitis A, B, or C; preexisting or acute liver disease; or another drug capable of causing the observed injury (排出其他可能的理由，例如病毒性肝炎、急性肝炎、其他可能藥物造成的損傷等)Ref: Guidance for Industry Drug-Induced Liver Injury: Premarketing Clinical Evaluation