Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
3463350 | Contemporary Clinical Trials | 2007 | 10 Pages |
Abstract
In conclusion, despite normal baseline values, most subjects demonstrated an increase in the ALT level even on placebo. For CE subjects, differences (âµALT and âµAST) 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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Authors
Louis R. Cantilena, Svetlana A. Cherstniakova, George Saviolakis, Roberta Kahn, Ahmed Elkashef, Lauren Rose, Frank Vocci,