Keratin-18 and microRNA-122 complement alanine aminotransferase as novel safety biomarkers for drug-induced liver injury in two human cohorts

Author:

Thulin Petra1,Nordahl Gunnar2,Gry Marcus2,Yimer Getnet3,Aklillu Eleni4,Makonnen Eyasu3,Aderaye Getachew5,Lindquist Lars6,Mattsson C. Mikael7,Ekblom Björn7,Antoine Daniel J.8,Park B. Kevin8,Linder Stig9,Harrill Alison H.10,Watkins Paul B.10,Glinghammar Björn11,Schuppe-Koistinen Ina1

Affiliation:

1. AstraZeneca R&D; Innovative Medicines Personalised Healthcare & Biomarkers; Science for Life Laboratory; Solna Sweden

2. Former AstraZeneca R&D; Global Safety Assessment; Molecular Toxicology; Södertälje Sweden

3. Department of Pharmacology; Faculty of Medicine; Addis Ababa University; Addis Ababa Ethiopia

4. Division of Clinical Pharmacology; Department of Laboratory Medicine; Karolinska Institutet; Karolinska University Hospital; Huddinge Sweden

5. Department of Internal Medicine; Faculty of Medicine; Addis Ababa University; Addis Ababa Ethiopia

6. Department of Medicine; Division of Infectious Diseases; Karolinska Institutet; Karolinska University Hospital; Huddinge Sweden

7. Åstrand Laboratory of Work Physiology; Swedish School of Sport and Health Sciences; Karolinska Institutet; Stockholm Sweden

8. MRC Centre for Drug Safety Science; Department of Molecular & Clinical Pharmacology; University of Liverpool; Liverpool UK

9. Department of Oncology-Pathology; Karolinska Institutet; Karolinska University Hospital; Solna Sweden

10. School of Pharmacy; University of North Carolina at Chapel Hill; Chapel Hill NC USA

11. AstraZeneca R&D; Drug Safety & Metabolism; Mölndal Sweden

Funder

European and Developing Countries Clinical Trial Partnership

Swedish Research Council

National Center for Advancing Translational Sciences

National Institutes of Health

Medical Research Council

Wellcome Trust Research Fellowship

Publisher

Wiley

Subject

Hepatology

Reference52 articles.

1. FDA Guidance for industry: drug-induced liver injury: premarketing clinical evaluation 2009 http://www.fda.gov/downloads/Drugs/.../Guidances/UCM174090.pdf

2. Review article: drug-induced liver injury in clinical practice;Bjornsson;Aliment Pharmacol Ther,2010

3. Transaminase activity in human blood;Karmen;J Clin Invest,1955

4. Concordance of the toxicity of pharmaceuticals in humans and in animals;Olson;Regul Toxicol Pharmacol,2000

5. Catalytic enzyme activity concentration in tissues of man, dog, rabbit, guinea pig, rat and mouse. Approach to a quantitative diagnostic enzymology, III. Communication;Lindena;J Clin Chem Clin Biochem,1986

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