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 Administ...

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Bibliographic Details
Published in:Clin Pharmacol Ther
Main Authors: Longo, DM, Generaux, GT, Howell, BA, Siler, SQ, Antoine, DJ, Button, D, Caggiano, A, Eisen, A, Iaci, J, Stanulis, R, Parry, T, Mosedale, M, Watkins, PB
Format: Artigo
Language:Inglês
Published: John Wiley and Sons Inc. 2017
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Research
Online Access:https://ncbi.nlm.nih.gov/pmc/articles/PMC5697568/
https://ncbi.nlm.nih.gov/pubmed/28419467
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1002/cpt.711
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