Article ID Journal Published Year Pages File Type
3463350 Contemporary Clinical Trials 2007 10 Pages PDF
Abstract
In conclusion, despite normal baseline values, most subjects demonstrated an increase in the ALT level even on placebo. For CE subjects, differences (▵ALT and ▵AST) between baseline and the maximum observed values were significantly higher than that observed for HN subjects. The potential to obscure important signals for hepatotoxicity during Phase 1 research may be higher in the CE study population.
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