In silico modeling to optimize interpretation of liver safety biomarkers in clinical trials
نویسندگان
چکیده
منابع مشابه
Refining Liver Safety Risk Assessment: Application of Mechanistic Modeling and Serum Biomarkers to Cimaglermin Alfa (GGF2) Clinical Trials
Cimaglermin alfa (GGF2) is a recombinant human protein growth factor in development for heart failure. Phase I trials were suspended when two cimaglermin alfa-treated subjects experienced concomitant elevations in serum aminotransferases and total bilirubin, meeting current US Food and Drug Administration criteria for a serious liver safety signal (i.e., "Hy's Law"). We assayed mechanistic biom...
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ژورنال
عنوان ژورنال: Experimental Biology and Medicine
سال: 2017
ISSN: 1535-3702,1535-3699
DOI: 10.1177/1535370217740853