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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...
Autores principales: | 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 |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5697568/ https://www.ncbi.nlm.nih.gov/pubmed/28419467 http://dx.doi.org/10.1002/cpt.711 |
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