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Page 1
A generic operational strategy to qualify translational safety biomarkers.
Matheis K, Laurie D, Andriamandroso C, Arber N, Badimon L, Benain X, Bendjama K, Clavier I, Colman P, Firat H, Goepfert J, Hall S, Joos T, Kraus S, Kretschmer A, Merz M, Padro T, Planatscher H, Rossi A, Schneiderhan-Marra N, Schuppe-Koistinen I, Thomann P, Vidal JM, Molac B. Matheis K, et al. Drug Discov Today. 2011 Jul;16(13-14):600-8. doi: 10.1016/j.drudis.2011.04.011. Epub 2011 May 6. Drug Discov Today. 2011. PMID: 21570476 Review.
Candidate biomarkers for the diagnosis and prognosis of drug-induced liver injury: An international collaborative effort.
Church RJ, Kullak-Ublick GA, Aubrecht J, Bonkovsky HL, Chalasani N, Fontana RJ, Goepfert JC, Hackman F, King NMP, Kirby S, Kirby P, Marcinak J, Ormarsdottir S, Schomaker SJ, Schuppe-Koistinen I, Wolenski F, Arber N, Merz M, Sauer JM, Andrade RJ, van Bömmel F, Poynard T, Watkins PB. Church RJ, et al. Hepatology. 2019 Feb;69(2):760-773. doi: 10.1002/hep.29802. Epub 2018 Jun 27. Hepatology. 2019. PMID: 29357190 Free PMC article.
Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Goodsaid FM, Amur S, Aubrecht J, Burczynski ME, Carl K, Catalano J, Charlab R, Close S, Cornu-Artis C, Essioux L, Fornace AJ Jr, Hinman L, Hong H, Hunt I, Jacobson-Kram D, Jawaid A, Laurie D, Lesko L, Li HH, Lindpaintner K, Mayne J, Morrow P, Papaluca-Amati M, Robison TW, Roth J, Schuppe-Koistinen I, Shi L, Spleiss O, Tong W, Truter SL, Vonderscher J, Westelinck A, Zhang L, Zineh I. Goodsaid FM, et al. Nat Rev Drug Discov. 2010 Jun;9(6):435-45. doi: 10.1038/nrd3116. Nat Rev Drug Discov. 2010. PMID: 20514070 Review.
Serum apolipoprotein A1 and haptoglobin, in patients with suspected drug-induced liver injury (DILI) as biomarkers of recovery.
Peta V, Tse C, Perazzo H, Munteanu M, Ngo Y, Ngo A, Ramanujam N, Verglas L, Mallet M, Ratziu V, Thabut D, Rudler M, Thibault V, Schuppe-Koistinen I, Bonnefont-Rousselot D, Hainque B, Imbert-Bismut F, Merz M, Kullak-Ublick G, Andrade R, van Boemmel F, Schott E, Poynard T; Drug Induced Liver Injury- Groupe Hospitalier Pitié-Salpêtrière; Drug Induced Liver Group of the Injury Safer and Faster Evidence-based Translation consortium. Peta V, et al. PLoS One. 2017 Dec 29;12(12):e0189436. doi: 10.1371/journal.pone.0189436. eCollection 2017. PLoS One. 2017. PMID: 29287080 Free PMC article.
Elevated levels of circulating CDH5 and FABP1 in association with human drug-induced liver injury.
Mikus M, Drobin K, Gry M, Bachmann J, Lindberg J, Yimer G, Aklillu E, Makonnen E, Aderaye G, Roach J, Fier I, Kampf C, Göpfert J, Perazzo H, Poynard T, Stephens C, Andrade RJ, Lucena MI, Arber N, Uhlén M, Watkins PB, Schwenk JM, Nilsson P, Schuppe-Koistinen I. Mikus M, et al. Liver Int. 2017 Jan;37(1):132-140. doi: 10.1111/liv.13174. Epub 2016 Jun 22. Liver Int. 2017. PMID: 27224670 Free PMC article.
Keratin-18 and microRNA-122 complement alanine aminotransferase as novel safety biomarkers for drug-induced liver injury in two human cohorts.
Thulin P, Nordahl G, Gry M, Yimer G, Aklillu E, Makonnen E, Aderaye G, Lindquist L, Mattsson CM, Ekblom B, Antoine DJ, Park BK, Linder S, Harrill AH, Watkins PB, Glinghammar B, Schuppe-Koistinen I. Thulin P, et al. Liver Int. 2014 Mar;34(3):367-78. doi: 10.1111/liv.12322. Epub 2013 Oct 14. Liver Int. 2014. PMID: 24118944
What are the best reference values for a normal serum alanine transaminase activity (ALT)? Impact on the presumed prevalence of drug induced liver injury (DILI).
M'Kada H, Munteanu M, Perazzo H, Ngo Y, Ramanujam N, Imbert-Bismut F, Ratziu V, Bonnefont-Rousselot D, Souberbielle B, Schuppe-Koistinen I, Poynard T; DILI group of the SAFE-T consortium. M'Kada H, et al. Regul Toxicol Pharmacol. 2011 Aug;60(3):290-5. doi: 10.1016/j.yrtph.2011.04.002. Epub 2011 Apr 24. Regul Toxicol Pharmacol. 2011. PMID: 21539883
Real time identification of drug-induced liver injury (DILI) through daily screening of ALT results: a prospective pilot cohort study.
M'Kada H, Perazzo H, Munteanu M, Ngo Y, Ramanujam N, Fautrel B, Imbert-Bismut F, Ratziu V, Schuppe-Koistinen I, Leblond V, Delattre JY, Samson Y, Caen OL, Bricaire F, Khayat D, Pierrot-Deseilligny C, Herson S, Amoura Z, Tilleul P, Deckmyn O, Coriat P, Delpech VN, Boulogne P, Bonnefont-Rousselot D, Poynard T; Drug Induced Liver Injury Groupe Hospitalier Pitié-Salpêtrière Group; Safer and Faster Evidence-based Translation Consortium. M'Kada H, et al. PLoS One. 2012;7(8):e42418. doi: 10.1371/journal.pone.0042418. Epub 2012 Aug 14. PLoS One. 2012. PMID: 22905129 Free PMC article.
75 results