Preclinical Observations
- Evidence for cholestasis
- Increase in plasma bile salts and alk phos
- No evidence for:
- Reactive or toxic metabolites
- Immuno-allergic reaction
- Centrolobular necrosis
- Mitochondrial toxicity
- Competitive inhibition of bile salt excretion (Bsep), which can lead to accumulation of bile salts and hepatocellular lysis