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Volumn 27, Issue 3, 2013, Pages 165-191

Drug-induced liver injury throughout the drug development life cycle: Where we have been, where we are now, and where we are headed. Perspectives of a clinical hepatologist

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ASPARTATE AMINOTRANSFERASE; BROMFENAC; LIVER ENZYME; TROGLITAZONE;

EID: 84878528772     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.1007/s40290-013-0015-5     Document Type: Review
Times cited : (19)

References (249)
  • 1
    • 84878619484 scopus 로고    scopus 로고
    • The drug development process. An FDA perspective
    • Friedman G, Jacobson ED, McCallum RW, editors Philadelphia: Lippincott-Raven Publishers
    • Temple R. The drug development process. An FDA perspective. In: Friedman G, Jacobson ED, McCallum RW, editors. Gastrointestinal pharmacology and therapeutics. Philadelphia: Lippincott-Raven Publishers; 1997. p. 677-92.
    • (1997) Gastrointestinal Pharmacology and Therapeutics , pp. 677-692
    • Temple, R.1
  • 2
    • 0020598444 scopus 로고
    • Investigations and reports respecting FDA regulations of new drugs (parts I and II)
    • 674-87
    • Hutt PB. Investigations and reports respecting FDA regulations of new drugs (parts I and II). Clinical Pharmacol Ther 1983;33(4):537-48, 674-87.
    • (1983) Clinical Pharmacol Ther , vol.33 , Issue.4 , pp. 537-548
    • Hutt, P.B.1
  • 3
    • 0029050027 scopus 로고
    • Studies and inquiries into the FDA regulatory process: A historical review
    • Shulman SR, Hewitt T, Manocchioa M. Studies and inquiries into the FDA regulatory process: a historical review. Drug Inf J. 1995;29:385-413.
    • (1995) Drug Inf J , vol.29 , pp. 385-413
    • Shulman, S.R.1    Hewitt, T.2    Manocchioa, M.3
  • 4
    • 58849132807 scopus 로고    scopus 로고
    • The future of drug safety testing: Expanding the view and narrowing the focus
    • 19100337
    • Stevens JL, Baker TK. The future of drug safety testing: expanding the view and narrowing the focus. Drug Discov Today. 2009;14(3-4):162-7.
    • (2009) Drug Discov Today , vol.14 , Issue.3-4 , pp. 162-167
    • Stevens, J.L.1    Baker, T.K.2
  • 5
    • 34548188788 scopus 로고    scopus 로고
    • Drug hepatotoxicity from a regulatory perspective
    • 17723917
    • Senior JR. Drug hepatotoxicity from a regulatory perspective. Clin Liver Dis. 2007;11:507-24.
    • (2007) Clin Liver Dis , vol.11 , pp. 507-524
    • Senior, J.R.1
  • 7
    • 84878581913 scopus 로고    scopus 로고
    • FDA. (Accessed 22 March 2013)
    • FDA. FDA drug development and approval process. http://www.fda.gov/drugs/ developmentapprovalprocess/default.htm. (Accessed 22 March 2013).
    • FDA Drug Development and Approval Process
  • 10
    • 0001511195 scopus 로고
    • Drug-induced liver disease: A penalty for progress
    • 1:STN:280:DyaF2M7js1Kktg%3D%3D 14331990
    • Popper H, Rubin E, Cardiol D, et al. Drug-induced liver disease: a penalty for progress. Arch Intern Med. 1965;115:128-36.
    • (1965) Arch Intern Med , vol.115 , pp. 128-136
    • Popper, H.1    Rubin, E.2    Cardiol, D.3
  • 11
    • 24944547571 scopus 로고    scopus 로고
    • Why drugs fail - A study on side effects in new chemical entities
    • 1:CAS:528:DC%2BD2MXhtVWrs7rE 16248807
    • Schuster D, Laggner C, Langer T. Why drugs fail - a study on side effects in new chemical entities. Curr Pharm Des. 2005;11(27):3545-59.
    • (2005) Curr Pharm des , vol.11 , Issue.27 , pp. 3545-3559
    • Schuster, D.1    Laggner, C.2    Langer, T.3
  • 12
    • 0033771951 scopus 로고    scopus 로고
    • Concordance of the toxicity of pharmaceuticals in humans and in animals
    • 1:CAS:528:DC%2BD3cXntF2gu7k%3D 11029269
    • Olson H. Concordance of the toxicity of pharmaceuticals in humans and in animals. Regul Toxicol Pharmacol. 2000;32(1):56-67.
    • (2000) Regul Toxicol Pharmacol , vol.32 , Issue.1 , pp. 56-67
    • Olson, H.1
  • 13
    • 84878605226 scopus 로고    scopus 로고
    • FDA (Accessed 22 March 2013)
    • FDA. Liver Toxicity Knowledge Base (LTKB) http://www.fda.gov/ ScienceResearch/BioinformaticsTools/LiverToxicityKnowledgeBase/default.htm (Accessed 22 March 2013).
    • Liver Toxicity Knowledge Base (LTKB)
  • 14
    • 0036570099 scopus 로고    scopus 로고
    • Timing of black box warnings and withdrawals for prescription medications
    • 11980521
    • Lasser KE, Allen PD, Woolhandler SJ, et al. Timing of black box warnings and withdrawals for prescription medications. JAMA. 2002;287(17):2215-20.
    • (2002) JAMA , vol.287 , Issue.17 , pp. 2215-2220
    • Lasser, K.E.1    Allen, P.D.2    Woolhandler, S.J.3
  • 15
    • 84878589001 scopus 로고    scopus 로고
    • FDA guidance exploratory studies FDA Working Group
    • November (Accessed 21 March 2013)
    • FDA guidance exploratory studies FDA Working Group. Nonclinical assessment of potential hepatotoxicity in man. November 2000. http://www.fda.gov/downloads/drugs/scienceresearch/researchareas/ucm091453.pdf (Accessed 21 March 2013).
    • (2000) Nonclinical Assessment of Potential Hepatotoxicity in Man
  • 16
    • 22144474788 scopus 로고    scopus 로고
    • Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: The importance of reporting suspected reactions
    • 15983284
    • Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002: the importance of reporting suspected reactions. Arch Intern Med. 2005;165(12):1363-9.
    • (2005) Arch Intern Med , vol.165 , Issue.12 , pp. 1363-1369
    • Wysowski, D.K.1    Swartz, L.2
  • 17
    • 0035210598 scopus 로고    scopus 로고
    • The role of databases in drug postmarketing surveillance
    • 1:STN:280:DC%2BD38%2FnsFeqtg%3D%3D 11802586
    • Rodriguez EM, Staffa JA, Graham DJ. The role of databases in drug postmarketing surveillance. Pharmacoepidemiol Drug Saf. 2001;10(5):407-10.
    • (2001) Pharmacoepidemiol Drug Saf , vol.10 , Issue.5 , pp. 407-410
    • Rodriguez, E.M.1    Staffa, J.A.2    Graham, D.J.3
  • 18
    • 0036300732 scopus 로고    scopus 로고
    • Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database
    • 1:CAS:528:DC%2BD38XlslOitrY%3D 12071774
    • Szarfman A, Machado SG, O'Neill RT. Use of screening algorithms and computer systems to efficiently signal higher-than-expected combinations of drugs and events in the US FDA's spontaneous reports database. Drug Saf. 2002;25(6):381-92.
    • (2002) Drug Saf , vol.25 , Issue.6 , pp. 381-392
    • Szarfman, A.1    MacHado, S.G.2    O'Neill, R.T.3
  • 20
    • 0037238861 scopus 로고    scopus 로고
    • Adverse drug event monitoring at the Food and Drug Administration
    • 12534765
    • Ahmad SR. Adverse drug event monitoring at the Food and Drug Administration. J Gen Intern Med. 2003;18(1):57-60.
    • (2003) J Gen Intern Med , vol.18 , Issue.1 , pp. 57-60
    • Ahmad, S.R.1
  • 22
    • 33746861906 scopus 로고    scopus 로고
    • Pharmacovigilance during the pre-approval phases: An evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines
    • 16872240
    • Hartford CG, Ptechel KS, Mickail H, et al. Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines. Drug Saf. 2006;29(8):657-73.
    • (2006) Drug Saf , vol.29 , Issue.8 , pp. 657-673
    • Hartford, C.G.1    Ptechel, K.S.2    Mickail, H.3
  • 23
    • 70349972263 scopus 로고    scopus 로고
    • Risk management policy and black-box warnings: A qualitative analysis of US FDA proceedings
    • 19810777
    • Cook DM, Gurugubelli RK, Bero LA. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings. Drug Saf. 2009;32(11):1057-66.
    • (2009) Drug Saf , vol.32 , Issue.11 , pp. 1057-1066
    • Cook, D.M.1    Gurugubelli, R.K.2    Bero, L.A.3
  • 24
    • 77954887903 scopus 로고    scopus 로고
    • The Food and Drug Administration's drug safety oversight board: An evolving paradigm for clinical input on drug safety topics
    • 1:STN:280:DC%2BC3cnos1SmtQ%3D%3D 20531466
    • Grandinetti CA, Osborne SF. The Food and Drug Administration's drug safety oversight board: an evolving paradigm for clinical input on drug safety topics. Clin Pharmacol Ther. 2010;88(2):269-74.
    • (2010) Clin Pharmacol Ther , vol.88 , Issue.2 , pp. 269-274
    • Grandinetti, C.A.1    Osborne, S.F.2
  • 25
    • 84855288564 scopus 로고    scopus 로고
    • Translating clinical findings into knowledge in drug safety evaluation - Drug-induced liver injury prediction system (DILIps)
    • Liu Z, Shi Q, Ding D, et al. Translating clinical findings into knowledge in drug safety evaluation - drug-induced liver injury prediction system (DILIps). PLoS Comput Biol. 2011;7(12):e1002310.
    • (2011) PLoS Comput Biol. , vol.7 , Issue.12
    • Liu, Z.1    Shi, Q.2    Ding, D.3
  • 26
    • 79851472033 scopus 로고    scopus 로고
    • Developing the sentinel system - A national resource for evidence development
    • 1:CAS:528:DC%2BC3MXhvVyisr4%3D 21226658
    • Behrman RE, Benner JS, Brown JS, et al. Developing the sentinel system - a national resource for evidence development. N Engl J Med. 2011;364(6):498-9.
    • (2011) N Engl J Med , vol.364 , Issue.6 , pp. 498-499
    • Behrman, R.E.1    Benner, J.S.2    Brown, J.S.3
  • 27
    • 84862932391 scopus 로고    scopus 로고
    • The US Food and Drug Administration's mini-sentinel program: Status and direction
    • 22262586
    • Platt R, Carnahan RM, Brown JS, et al. The US Food and Drug Administration's mini-sentinel program: status and direction. Pharmacoepidemiol Drug Saf. 2012;21(suppl 1):1-8.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.SUPPL. 1 , pp. 1-8
    • Platt, R.1    Carnahan, R.M.2    Brown, J.S.3
  • 29
    • 79960098048 scopus 로고    scopus 로고
    • New FDA regulation to improve safety reporting in clinical trials
    • 1:CAS:528:DC%2BC3MXovVaru7w%3D 21651388
    • Sherman RB, Woodcock J, Norden J, et al. New FDA regulation to improve safety reporting in clinical trials. N Engl J Med. 2011;365(1):3-5.
    • (2011) N Engl J Med , vol.365 , Issue.1 , pp. 3-5
    • Sherman, R.B.1    Woodcock, J.2    Norden, J.3
  • 30
    • 84867737863 scopus 로고    scopus 로고
    • The Drug Safety and Risk Management Advisory Committee: A case study of meeting frequency, content, and outcomes before and after FDAAA
    • 23047787
    • Morrato EH, Ling SB. The Drug Safety and Risk Management Advisory Committee: a case study of meeting frequency, content, and outcomes before and after FDAAA. Med Care. 2012;50(11):970-86.
    • (2012) Med Care , vol.50 , Issue.11 , pp. 970-986
    • Morrato, E.H.1    Ling, S.B.2
  • 31
    • 33646024613 scopus 로고    scopus 로고
    • Hy's law: Predicting serious hepatotoxicity
    • 16552790
    • Temple R. Hy's law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15(4):241-3.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , Issue.4 , pp. 241-243
    • Temple, R.1
  • 32
    • 0037353404 scopus 로고    scopus 로고
    • Troglitazone-induced liver failure: A case-study
    • 12681458
    • Graham DJ, Green L, Senior JR, et al. Troglitazone-induced liver failure: a case-study. Am J Med. 2003;114(4):299-306.
    • (2003) Am J Med , vol.114 , Issue.4 , pp. 299-306
    • Graham, D.J.1    Green, L.2    Senior, J.R.3
  • 33
    • 0035698519 scopus 로고    scopus 로고
    • Troglitazone (Rezulin) and hepatic injury
    • 1:CAS:528:DC%2BD38Xhtleiu7o%3D 11828837
    • Faich GA, Moseley RH. Troglitazone (Rezulin) and hepatic injury. Pharmacoepidemiol Drug Saf. 2001;10(6):537-47.
    • (2001) Pharmacoepidemiol Drug Saf , vol.10 , Issue.6 , pp. 537-547
    • Faich, G.A.1    Moseley, R.H.2
  • 34
    • 0032701360 scopus 로고    scopus 로고
    • Acute liver failure associated with prolonged use of bromfenac leading to liver transplant
    • 1:STN:280:DC%2BD3c%2FhsFaqug%3D%3D 10545534
    • Fontana RJ, McCashland TM, Brenner KG, et al. Acute liver failure associated with prolonged use of bromfenac leading to liver transplant. Liver Transpl Surg. 1999;5(6):480-4.
    • (1999) Liver Transpl Surg , vol.5 , Issue.6 , pp. 480-484
    • Fontana, R.J.1    McCashland, T.M.2    Brenner, K.G.3
  • 35
    • 33646038234 scopus 로고    scopus 로고
    • A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: Lessons learned from the bromfenac experience
    • Goldkind L, Laine L. A systematic review of NSAIDs withdrawn from the market due to hepatotoxicity: lessons learned from the bromfenac experience. Pharmacoepidemiol Drug Saf. 2006;15.
    • (2006) Pharmacoepidemiol Drug Saf. , pp. 15
    • Goldkind, L.1    Laine, L.2
  • 36
    • 0034012255 scopus 로고    scopus 로고
    • Trovafloxacin-induced acute hepatitis
    • Tancik CA, Dillaha JA. Trovafloxacin-induced acute hepatitis. Clin Infect Dis. 2000;30(2):400.
    • (2000) Clin Infect Dis , vol.30 , Issue.2 , pp. 400
    • Tancik, C.A.1    Dillaha, J.A.2
  • 38
    • 79960272194 scopus 로고    scopus 로고
    • Guidance for industry
    • Food and Drug Administration, Silver Spring (Accessed 21 March 2013)
    • Guidance for industry. Drug-induced liver injury: premarketing clinical evaluation. Food and Drug Administration, Silver Spring; 2009. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/ Guidances/UCM174090.pdf (Accessed 21 March 2013).
    • (2009) Drug-induced Liver Injury: Premarketing Clinical Evaluation
  • 39
    • 33645220583 scopus 로고    scopus 로고
    • Drug-induced liver injury: Summary of a single topic clinical research conference
    • 16496329
    • Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology. 2006;43(3):618-31.
    • (2006) Hepatology , vol.43 , Issue.3 , pp. 618-631
    • Watkins, P.B.1    Seeff, L.B.2
  • 40
    • 78649625452 scopus 로고    scopus 로고
    • Drug-induced acute liver failure: Results of a US multicenter, prospective study
    • 20949552
    • Reuben A, Koch DG, Lee WM, et al. Drug-induced acute liver failure: results of a US multicenter, prospective study. Hepatology. 2010;52(6):2065-76.
    • (2010) Hepatology , vol.52 , Issue.6 , pp. 2065-2076
    • Reuben, A.1    Koch, D.G.2    Lee, W.M.3
  • 41
    • 84874493748 scopus 로고    scopus 로고
    • Liver Tox. A web site on drug induced liver injury
    • 23456678
    • Hoofnagle JH, Serrano J, Knoben JE, et al. Liver Tox. A web site on drug induced liver injury. Hepatology. 2013;57(3):873-4.
    • (2013) Hepatology , vol.57 , Issue.3 , pp. 873-874
    • Hoofnagle, J.H.1    Serrano, J.2    Knoben, J.E.3
  • 42
    • 84882888735 scopus 로고    scopus 로고
    • Hepatic injury due to drugs, herbal compounds, chemicals and toxins
    • A.D. Burt B.C. Portmann L.D. Ferrell (eds) 6 Churchill Livingstone/Elsevier Edinburgh
    • Lewis JH, Kleiner DE. Hepatic injury due to drugs, herbal compounds, chemicals and toxins. In: Burt AD, Portmann BC, Ferrell LD, editors. MacSween's pathology of the liver. 6th ed. Edinburgh: Churchill Livingstone/Elsevier; 2012. p. 645-760.
    • (2012) MacSween's Pathology of the Liver , pp. 645-760
    • Lewis, J.H.1    Kleiner, D.E.2
  • 43
    • 33847251560 scopus 로고    scopus 로고
    • Etiology of new-onset jaundice: How often is it caused by idiosyncratic drug-induced liver injury in the United States?
    • 17156142
    • Vuppalanchi R, Liangpunsakul S, Chalasani N. Etiology of new-onset jaundice: how often is it caused by idiosyncratic drug-induced liver injury in the United States? Am J Gastroenterol. 2007;102(3):558-62.
    • (2007) Am J Gastroenterol , vol.102 , Issue.3 , pp. 558-562
    • Vuppalanchi, R.1    Liangpunsakul, S.2    Chalasani, N.3
  • 44
    • 68349141269 scopus 로고    scopus 로고
    • Outcome of liver transplantation for drug-induced acute liver failure in the United States: Analysis of the United Network for Organ Sharing database
    • 19562705
    • Mindikoglu AL, Magder LS, Regev A. Outcome of liver transplantation for drug-induced acute liver failure in the United States: analysis of the United Network for Organ Sharing database. Liver Transpl. 2009;15(7):719-29.
    • (2009) Liver Transpl , vol.15 , Issue.7 , pp. 719-729
    • Mindikoglu, A.L.1    Magder, L.S.2    Regev, A.3
  • 45
    • 0033652840 scopus 로고    scopus 로고
    • Assessing causality in drug-induced liver injury
    • 1:STN:280:DC%2BD3M7it1OhsA%3D%3D 11131436
    • Lee WM. Assessing causality in drug-induced liver injury. J Hepatol. 2000;33(6):1003-5.
    • (2000) J Hepatol , vol.33 , Issue.6 , pp. 1003-1005
    • Lee, W.M.1
  • 46
    • 0035986526 scopus 로고    scopus 로고
    • Drug hepatotoxicity
    • 12122862
    • Goodman Z. Drug hepatotoxicity. Clin Liver Dis. 2002;6(2):381-9.
    • (2002) Clin Liver Dis , vol.6 , Issue.2 , pp. 381-389
    • Goodman, Z.1
  • 47
    • 0034950046 scopus 로고    scopus 로고
    • Drug-induced liver disorders: Implications for drug development and regulation
    • 1:CAS:528:DC%2BD3MXlt1Gkt7s%3D 11444721
    • Kaplowitz N. Drug-induced liver disorders: implications for drug development and regulation. Drug Saf. 2001;24(7):483-90.
    • (2001) Drug Saf , vol.24 , Issue.7 , pp. 483-490
    • Kaplowitz, N.1
  • 48
    • 70449124654 scopus 로고    scopus 로고
    • The pathology of drug-induced liver injury
    • 19826970
    • Kleiner DE. The pathology of drug-induced liver injury. Semin Liver Dis. 2009;29(4):364-72.
    • (2009) Semin Liver Dis , vol.29 , Issue.4 , pp. 364-372
    • Kleiner, D.E.1
  • 50
    • 0025227871 scopus 로고
    • Consensus. Criteria of drug-induced liver disorders. Report of an international consensus meeting
    • 1:STN:280:DyaK3M%2Fnt12gtQ%3D%3D 2254635
    • Benichou C, Benhamou JP, Danan G. Consensus. Criteria of drug-induced liver disorders. Report of an international consensus meeting. J Hepatol. 1990;11(2):272-6.
    • (1990) J Hepatol , vol.11 , Issue.2 , pp. 272-276
    • Benichou, C.1    Benhamou, J.P.2    Danan, G.3
  • 51
    • 0025075173 scopus 로고
    • Standardization of definitions and criteria of causality assessment of adverse drug reactions. Drug-induced liver disorders: Report of an international consensus meeting
    • Benichou C. Standardization of definitions and criteria of causality assessment of adverse drug reactions. Drug-induced liver disorders: report of an international consensus meeting. Int J Clin Pharmacol Ther Toxicol. 1990;28(8):317-22.
    • (1990) Int J Clin Pharmacol Ther Toxicol , vol.28 , Issue.8 , pp. 317-322
    • Benichou, C.1
  • 52
    • 33646024905 scopus 로고    scopus 로고
    • How can "hy's law" help the clinician?
    • 16552792
    • Senior JR. How can "Hy's law" help the clinician? Pharmacoepidemiol Drug Saf. 2006;15(4):235-9.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , Issue.4 , pp. 235-239
    • Senior, J.R.1
  • 53
    • 67650980657 scopus 로고
    • Serum enzymes in disease. VII. Significance of abnormal serum enzyme levels in cardiac failure
    • 1:CAS:528:DyaF3MXhtlyktbg%3D 13784591
    • West M, Gelb D, Pilz CG, Zimmerman HJ. Serum enzymes in disease. VII. Significance of abnormal serum enzyme levels in cardiac failure. Am J Med Sci. 1961;241:350-8.
    • (1961) Am J Med Sci , vol.241 , pp. 350-358
    • West, M.1    Gelb, D.2    Pilz, C.G.3    Zimmerman, H.J.4
  • 54
    • 48049108896 scopus 로고
    • Serum enzymes in disease. III. Lactic dehydrogenase and glutamic oxaloacetic transaminase in patients with leukemia and lymphoma
    • 1:CAS:528:DyaG1MXhtVWjtr0%3D 13533433
    • West M, Heller P, Zimmerman HJ. Serum enzymes in disease. III. Lactic dehydrogenase and glutamic oxaloacetic transaminase in patients with leukemia and lymphoma. Am J Med Sci. 1958;235(6):689-701.
    • (1958) Am J Med Sci , vol.235 , Issue.6 , pp. 689-701
    • West, M.1    Heller, P.2    Zimmerman, H.J.3
  • 55
    • 70449190229 scopus 로고
    • Lactic dehydrogenase and glutamic oxaloacetic transaminase in normal pregnant women and newborn children
    • 1:CAS:528:DyaF3MXhtFejt7o%3D 13520729
    • West M, Zimmerman HJ. Lactic dehydrogenase and glutamic oxaloacetic transaminase in normal pregnant women and newborn children. Am J Med Sci. 1958;235(4):443-7.
    • (1958) Am J Med Sci , vol.235 , Issue.4 , pp. 443-447
    • West, M.1    Zimmerman, H.J.2
  • 56
    • 78651033600 scopus 로고
    • Studies of hepatic function in patients receiving promazine
    • 1:STN:280:DyaG1c%2FmtlGqtg%3D%3D 13520727
    • Korn RJ, Rock W, Zimmerman HJ. Studies of hepatic function in patients receiving promazine. Am J Med Sci. 1958;235(4):431-6.
    • (1958) Am J Med Sci , vol.235 , Issue.4 , pp. 431-436
    • Korn, R.J.1    Rock, W.2    Zimmerman, H.J.3
  • 57
    • 0014298882 scopus 로고
    • Hepatotoxicity of phenothiazines in vitro as measured by loss of aminotransferases to surrounding media
    • 1:CAS:528:DyaF1cXks1Gqtr8%3D 5663272
    • Dujovne CA, Levy R, Zimmerman HJ. Hepatotoxicity of phenothiazines in vitro as measured by loss of aminotransferases to surrounding media. Proc Soc Exp Biol Med. 1968;128(2):561-3.
    • (1968) Proc Soc Exp Biol Med , vol.128 , Issue.2 , pp. 561-563
    • Dujovne, C.A.1    Levy, R.2    Zimmerman, H.J.3
  • 58
    • 60349087845 scopus 로고    scopus 로고
    • Monitoring for hepatotoxicity: What is the predictive value of liver 'function' tests?
    • 1:CAS:528:DC%2BD1MXit1Ogtbc%3D 19129750
    • Senior JR. Monitoring for hepatotoxicity: what is the predictive value of liver 'function' tests? Clin Pharmacol Ther. 2009;85(3):331-4.
    • (2009) Clin Pharmacol Ther , vol.85 , Issue.3 , pp. 331-334
    • Senior, J.R.1
  • 59
    • 0036789250 scopus 로고    scopus 로고
    • American Gastroenterological Association position statement: Evaluation of liver chemistry tests
    • American Gastroenterological Association position statement: evaluation of liver chemistry tests. Gastroenterology. 2002;123(4):1364-6.
    • (2002) Gastroenterology , vol.123 , Issue.4 , pp. 1364-1366
  • 60
    • 0036787433 scopus 로고    scopus 로고
    • AGA Technical review on the evaluation of liver chemistry tests
    • 12360498
    • Green RM, Flamm S. AGA Technical review on the evaluation of liver chemistry tests. Gastroenterology. 2002;123(4):1367-84.
    • (2002) Gastroenterology , vol.123 , Issue.4 , pp. 1367-1384
    • Green, R.M.1    Flamm, S.2
  • 61
    • 12844268517 scopus 로고    scopus 로고
    • Serum alanine aminotransferase in skeletal muscle diseases
    • 1:CAS:528:DC%2BD2MXhsVantrs%3D 15660433
    • Nathwani RA, Pais S, Reynolds TB, et al. Serum alanine aminotransferase in skeletal muscle diseases. Hepatology. 2005;41(2):380-2.
    • (2005) Hepatology , vol.41 , Issue.2 , pp. 380-382
    • Nathwani, R.A.1    Pais, S.2    Reynolds, T.B.3
  • 62
    • 1642272235 scopus 로고    scopus 로고
    • Drug- and chemical-induced cholestasis
    • 15062196
    • Mohi-ud-din R, Lewis JH. Drug- and chemical-induced cholestasis. Clin Liver Dis. 2004;8(1):95-132.
    • (2004) Clin Liver Dis , vol.8 , Issue.1 , pp. 95-132
    • Mohi-Ud-Din, R.1    Lewis, J.H.2
  • 63
    • 84878537587 scopus 로고    scopus 로고
    • Bilirubin metabolism and jaundice
    • Schiff ER, Maddrey WC, Sorredll MF, editors 11th ed. New York: Wiley-Blackwell
    • Wolkoff AW, Berk PD. Bilirubin metabolism and jaundice. In: Schiff ER, Maddrey WC, Sorredll MF, editors. Schiff's diseases of the liver. 11th ed. New York: Wiley-Blackwell; 2012. p. 120-51.
    • (2012) Schiff's Diseases of the Liver , pp. 120-151
    • Wolkoff, A.W.1    Berk, P.D.2
  • 64
    • 84869434683 scopus 로고    scopus 로고
    • Latest advances in predicting DILI in human subjects: Focus on biomarkers
    • 1:CAS:528:DC%2BC38Xhs12jsrnJ 22998122
    • Hawkins MT, Lewis JH. Latest advances in predicting DILI in human subjects: focus on biomarkers. Expert Opin Drug Metab Toxicol. 2012;8(12):1521-30.
    • (2012) Expert Opin Drug Metab Toxicol , vol.8 , Issue.12 , pp. 1521-1530
    • Hawkins, M.T.1    Lewis, J.H.2
  • 65
    • 0034253912 scopus 로고    scopus 로고
    • Ischemic hepatitis: Clinical presentation and pathogenesis
    • 1:STN:280:DC%2BD3cvosV2hsA%3D%3D 10967151
    • Seeto RK, Fenn B, Rockey DC. Ischemic hepatitis: clinical presentation and pathogenesis. Am J Med. 2000;109(2):109-13.
    • (2000) Am J Med , vol.109 , Issue.2 , pp. 109-113
    • Seeto, R.K.1    Fenn, B.2    Rockey, D.C.3
  • 66
    • 0344497346 scopus 로고    scopus 로고
    • Hypoxic hepatitis: Clinical and hemodynamic study in 142 consecutive cases
    • Henrion J, Schapira M, Luwaert R, et al. Hypoxic hepatitis: clinical and hemodynamic study in 142 consecutive cases. Medicine (Baltimore). 2003;82(6):392-406.
    • (2003) Medicine (Baltimore) , vol.82 , Issue.6 , pp. 392-406
    • Henrion, J.1    Schapira, M.2    Luwaert, R.3
  • 67
    • 0014067313 scopus 로고
    • Steatonecrosis - Mallory body type
    • 1:STN:280:DyaF2s7ntFOgsA%3D%3D
    • Harinasuta U, Chomet B, Ishak K, et al. Steatonecrosis - Mallory body type. Medicine (Baltimore). 1967;46(2):141-62.
    • (1967) Medicine (Baltimore) , vol.46 , Issue.2 , pp. 141-162
    • Harinasuta, U.1    Chomet, B.2    Ishak, K.3
  • 68
    • 78649473610 scopus 로고    scopus 로고
    • Duloxetine hepatotoxicity: A case-series from the drug-induced liver injury network
    • 1:CAS:528:DC%2BC3cXhsVKqtLzJ 20815829
    • Vuppalanchi R, Hayashi PH, Chalasani N, et al. Duloxetine hepatotoxicity: a case-series from the drug-induced liver injury network. Aliment Pharmacol Ther. 2010;32(9):1174-83.
    • (2010) Aliment Pharmacol Ther , vol.32 , Issue.9 , pp. 1174-1183
    • Vuppalanchi, R.1    Hayashi, P.H.2    Chalasani, N.3
  • 69
    • 0035088204 scopus 로고    scopus 로고
    • Drug-induced liver injury - Mechanisms and test systems
    • 1:STN:280:DC%2BD3M3ivVOltQ%3D%3D 11283870
    • Bissell DM, Gores GJ, Laskin DL, et al. Drug-induced liver injury - mechanisms and test systems. Hepatology. 2001;33(4):1009-13.
    • (2001) Hepatology , vol.33 , Issue.4 , pp. 1009-1013
    • Bissell, D.M.1    Gores, G.J.2    Laskin, D.L.3
  • 70
    • 20844444779 scopus 로고    scopus 로고
    • Idiosyncratic drug hepatotoxicity
    • Kaplowitz M. Idiosyncratic drug hepatotoxicity. Nature Rev Drug Discov. 2005;4:489-9.
    • (2005) Nature Rev Drug Discov. , vol.4 , pp. 489-489
    • Kaplowitz, M.1
  • 71
    • 34548127553 scopus 로고    scopus 로고
    • Mechanisms of drug-induced liver disease
    • 17723915
    • Gunawan VK, Kaplowitz N. Mechanisms of drug-induced liver disease. Clin Liver Dis. 2007;11(3):459-75.
    • (2007) Clin Liver Dis , vol.11 , Issue.3 , pp. 459-475
    • Gunawan, V.K.1    Kaplowitz, N.2
  • 72
    • 0041342015 scopus 로고    scopus 로고
    • Drug-induced hepatotoxicity
    • 1:CAS:528:DC%2BD3sXms1Ogs78%3D 12890847
    • Lee WM. Drug-induced hepatotoxicity. N Engl J Med. 2003;349(5):474-85.
    • (2003) N Engl J Med , vol.349 , Issue.5 , pp. 474-485
    • Lee, W.M.1
  • 73
    • 32644469104 scopus 로고    scopus 로고
    • Drug-related hepatotoxicity
    • 1:CAS:528:DC%2BD28XhsVWrtr8%3D 16481640
    • Navarro VJ, Senior JR. Drug-related hepatotoxicity. N Engl J Med. 2006;354(7):731-9.
    • (2006) N Engl J Med , vol.354 , Issue.7 , pp. 731-739
    • Navarro, V.J.1    Senior, J.R.2
  • 74
    • 0032558588 scopus 로고    scopus 로고
    • Molecular basis of cholestasis
    • 1:CAS:528:DyaK1cXntFGiur4%3D 9780343
    • Trauner M, Meier PJ, Boyer JL. Molecular basis of cholestasis. N Engl J Med. 1998;339(17):1217-27.
    • (1998) N Engl J Med , vol.339 , Issue.17 , pp. 1217-1227
    • Trauner, M.1    Meier, P.J.2    Boyer, J.L.3
  • 75
    • 79956313436 scopus 로고    scopus 로고
    • A fresh look at the mechanism of isoniazid-induced hepatotoxicity
    • 1:CAS:528:DC%2BC3MXmtlagtbc%3D 21412230
    • Metushi IG, Cai P, Zhu X, et al. A fresh look at the mechanism of isoniazid-induced hepatotoxicity. Clin Pharmacol Ther. 2011;89(6):911-4.
    • (2011) Clin Pharmacol Ther , vol.89 , Issue.6 , pp. 911-914
    • Metushi, I.G.1    Cai, P.2    Zhu, X.3
  • 76
    • 70350228380 scopus 로고    scopus 로고
    • Diagnosis, management, and prevention of drug-induced liver injury
    • 1:CAS:528:DC%2BD1MXhs1ahs7jE 19834119
    • Verma S, Kaplowitz N. Diagnosis, management, and prevention of drug-induced liver injury. Gut. 2009;58(11):1555-64.
    • (2009) Gut , vol.58 , Issue.11 , pp. 1555-1564
    • Verma, S.1    Kaplowitz, N.2
  • 77
    • 0033825738 scopus 로고    scopus 로고
    • Drug-induced liver disease
    • 1:STN:280:DC%2BD3cvns1ymuw%3D%3D 11026929
    • Lewis JH. Drug-induced liver disease. Med Clin North Am. 2000;84(5):1275-311.
    • (2000) Med Clin North Am , vol.84 , Issue.5 , pp. 1275-1311
    • Lewis, J.H.1
  • 78
    • 68949091980 scopus 로고    scopus 로고
    • Phenotypic characterization of idiosyncratic drug-induced liver injury: The influence of age and sex
    • 19475693
    • Lucena M, Andrade R, Kaplowitz N, et al. Phenotypic characterization of idiosyncratic drug-induced liver injury: the influence of age and sex. Hepatology. 2009;49(6):2001-9.
    • (2009) Hepatology , vol.49 , Issue.6 , pp. 2001-2009
    • Lucena, M.1    Andrade, R.2    Kaplowitz, N.3
  • 79
    • 77950676999 scopus 로고    scopus 로고
    • Mechanisms of pathogenesis in drug hepatotoxicity putting the stress on mitochondria
    • 1:CAS:528:DC%2BC3cXmtVeqtrk%3D 20368370
    • Jones DP, Lemasters JJ, Han D, et al. Mechanisms of pathogenesis in drug hepatotoxicity putting the stress on mitochondria. Mol Interv. 2010;10(2):98-111.
    • (2010) Mol Interv , vol.10 , Issue.2 , pp. 98-111
    • Jones, D.P.1    Lemasters, J.J.2    Han, D.3
  • 80
    • 33947204690 scopus 로고    scopus 로고
    • Mitochondrial abnormalities - A link to idiosyncratic drug hepatotoxicity?
    • 1:CAS:528:DC%2BD2sXjsVemt7s%3D 17275868
    • Boelsterli UA, Lim PL. Mitochondrial abnormalities - a link to idiosyncratic drug hepatotoxicity? Toxicol Appl Pharmacol. 2007;220(1):92-107.
    • (2007) Toxicol Appl Pharmacol , vol.220 , Issue.1 , pp. 92-107
    • Boelsterli, U.A.1    Lim, P.L.2
  • 81
    • 17644410776 scopus 로고    scopus 로고
    • Role of drug metabolism for breaking tolerance and the localization of drug hypersensitivity
    • 1:CAS:528:DC%2BD2MXitlCisbo%3D 15767022
    • Uetrecht J. Role of drug metabolism for breaking tolerance and the localization of drug hypersensitivity. Toxicology. 2005;209(2):113-8.
    • (2005) Toxicology , vol.209 , Issue.2 , pp. 113-118
    • Uetrecht, J.1
  • 82
    • 77949328370 scopus 로고    scopus 로고
    • Signal transduction pathways involved in drug-induced liver injury
    • 1:CAS:528:DC%2BC3cXnvVynu7Y%3D 20020266
    • Han D, Shinohara M, Ybanez MD, et al. Signal transduction pathways involved in drug-induced liver injury. Handb Exp Pharmacol. 2010;196:267-310.
    • (2010) Handb Exp Pharmacol , vol.196 , pp. 267-310
    • Han, D.1    Shinohara, M.2    Ybanez, M.D.3
  • 83
    • 84857307490 scopus 로고    scopus 로고
    • The primary role of hepatic metabolism in idiosyncratic drug-induced liver injury
    • 1:CAS:528:DC%2BC38XisFWitLw%3D 22288564
    • Amacher DE. The primary role of hepatic metabolism in idiosyncratic drug-induced liver injury. Expert Opin Drug Metab Toxicol. 2012;8(3):335-47.
    • (2012) Expert Opin Drug Metab Toxicol , vol.8 , Issue.3 , pp. 335-347
    • Amacher, D.E.1
  • 84
    • 70449103049 scopus 로고    scopus 로고
    • Genetic association studies in drug-induced liver injury
    • 1:CAS:528:DC%2BD1MXhtl2ksL3F 19826974
    • Daly AK, Day CP. Genetic association studies in drug-induced liver injury. Semin Liver Dis. 2009;29(4):400-11.
    • (2009) Semin Liver Dis , vol.29 , Issue.4 , pp. 400-411
    • Daly, A.K.1    Day, C.P.2
  • 85
    • 77951553451 scopus 로고    scopus 로고
    • Drug-induced liver injury: Past, present, and future
    • Daly AK. Drug-induced liver injury: past, present, and future. Pharmacogenomics. 2010;5:607-11.
    • (2010) Pharmacogenomics , vol.5 , pp. 607-611
    • Daly, A.K.1
  • 86
    • 84855908033 scopus 로고    scopus 로고
    • Genetic association studies in drug-induced liver injury
    • 1:CAS:528:DC%2BC38XhtVGlur0%3D 21913872
    • Daly ASK, Day CP. Genetic association studies in drug-induced liver injury. Drug Metab Rev. 2012;44(1):116-26.
    • (2012) Drug Metab Rev , vol.44 , Issue.1 , pp. 116-126
    • Daly, A.S.K.1    Day, C.P.2
  • 87
    • 70449117614 scopus 로고    scopus 로고
    • Immunoallergic drug-induced liver injury in humans
    • 1:CAS:528:DC%2BD1MXhtl2ksL3K 19826972
    • Uetrecht J. Immunoallergic drug-induced liver injury in humans. Semin Liver Dis. 2009;29(4):383-92.
    • (2009) Semin Liver Dis , vol.29 , Issue.4 , pp. 383-392
    • Uetrecht, J.1
  • 88
    • 46249118651 scopus 로고    scopus 로고
    • Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: Search for signals
    • 1:CAS:528:DC%2BD1cXotVagt7w%3D 18454504
    • Lammert C, Einarsson S, Saha C, et al. Relationship between daily dose of oral medications and idiosyncratic drug-induced liver injury: search for signals. Hepatology. 2008;47(6):2003-9.
    • (2008) Hepatology , vol.47 , Issue.6 , pp. 2003-2009
    • Lammert, C.1    Einarsson, S.2    Saha, C.3
  • 89
    • 75449112589 scopus 로고    scopus 로고
    • Oral medications with significant hepatic metabolism at higher risk for hepatic adverse effects
    • 1:CAS:528:DC%2BC3cXisVGnsr8%3D 19839004
    • Lammert C, Bjornsson E, Niklasson A, et al. Oral medications with significant hepatic metabolism at higher risk for hepatic adverse effects. Hepatology. 2010;51(2):615-20.
    • (2010) Hepatology , vol.51 , Issue.2 , pp. 615-620
    • Lammert, C.1    Bjornsson, E.2    Niklasson, A.3
  • 90
    • 84863749250 scopus 로고    scopus 로고
    • Animal models of idiosyncratic drug reactions
    • 1:CAS:528:DC%2BC38XhtlersbnO 22776640
    • Ng W, Lobach AR, Zhu X, et al. Animal models of idiosyncratic drug reactions. Adv Pharmacol. 2012;63:81-135.
    • (2012) Adv Pharmacol , vol.63 , pp. 81-135
    • Ng, W.1    Lobach, A.R.2    Zhu, X.3
  • 91
    • 84868618214 scopus 로고    scopus 로고
    • Current challenges and controversies in drug-induced liver injury
    • 1:CAS:528:DC%2BC3sXhsVCitw%3D%3D 23137150
    • Corsini A, Ganey P, Ju C, et al. Current challenges and controversies in drug-induced liver injury. Drug Saf. 2012;35(12):1099-117.
    • (2012) Drug Saf , vol.35 , Issue.12 , pp. 1099-1117
    • Corsini, A.1    Ganey, P.2    Ju, C.3
  • 92
    • 84862932616 scopus 로고    scopus 로고
    • Is toxicogenomics a more reliable and sensitive biomarker than conventional indicators from rats to predict drug-induced injury in humans
    • 1:CAS:528:DC%2BC3MXhsFaktb3N 22122743
    • Zhang M, Chen M, Tong W. Is toxicogenomics a more reliable and sensitive biomarker than conventional indicators from rats to predict drug-induced injury in humans. Chem Res Toxicol. 2012;25(1):122-9.
    • (2012) Chem Res Toxicol , vol.25 , Issue.1 , pp. 122-129
    • Zhang, M.1    Chen, M.2    Tong, W.3
  • 93
    • 0025039064 scopus 로고
    • Biochemical changes and morphological alterations of the liver in guinea-pigs after administration of simvastatin (HMG CoA reductase-inhibitor)
    • 1:CAS:528:DyaK3MXpsV2mtQ%3D%3D 2077527
    • Horsmans Y, Desager JP, Harvengt C. Biochemical changes and morphological alterations of the liver in guinea-pigs after administration of simvastatin (HMG CoA reductase-inhibitor). Pharmacol Toxicol. 1990;67(4):336-9.
    • (1990) Pharmacol Toxicol , vol.67 , Issue.4 , pp. 336-339
    • Horsmans, Y.1    Desager, J.P.2    Harvengt, C.3
  • 94
    • 0024512235 scopus 로고
    • Toxicity of HMG-coenzyme A reductase inhibitor, lovastatin, to rabbits
    • 1:CAS:528:DyaL1MXhsVOmsLk%3D 2918466
    • Kornbrust DJ, MacDonald JS, Peter CP, et al. Toxicity of HMG-coenzyme A reductase inhibitor, lovastatin, to rabbits. J Pharmacol Exp Ther. 1989;248(2):498-505.
    • (1989) J Pharmacol Exp Ther , vol.248 , Issue.2 , pp. 498-505
    • Kornbrust, D.J.1    MacDonald, J.S.2    Peter, C.P.3
  • 95
    • 84864280822 scopus 로고    scopus 로고
    • Clinical perspective: Statins and the liver - Harmful or helpful?
    • 22581301
    • Lewis JH. Clinical perspective: statins and the liver - harmful or helpful? Dig Dis Sci. 2012;57(7):1754-63.
    • (2012) Dig Dis Sci , vol.57 , Issue.7 , pp. 1754-1763
    • Lewis, J.H.1
  • 96
    • 29544450979 scopus 로고    scopus 로고
    • Mode of action in relevance of rodent liver tumors to human cancer risk
    • 1:CAS:528:DC%2BD2MXhtlagtLnN 16221960
    • Holsapple MP, Pitot HC, Cohen SH, et al. Mode of action in relevance of rodent liver tumors to human cancer risk. Toxicol Sci. 2006;89(1):51-6.
    • (2006) Toxicol Sci , vol.89 , Issue.1 , pp. 51-56
    • Holsapple, M.P.1    Pitot, H.C.2    Cohen, S.H.3
  • 97
    • 33747126524 scopus 로고    scopus 로고
    • Role of animal models in the study of drug-induced hypersensitivity reactions
    • 16594644
    • Uetrecht J. Role of animal models in the study of drug-induced hypersensitivity reactions. AAPS J. 2006;7(4):E914-21.
    • (2006) AAPS J , vol.7 , Issue.4
    • Uetrecht, J.1
  • 98
    • 33947595809 scopus 로고    scopus 로고
    • Healthy animals and animal models of human disease(s) in safety assessment of human pharmaceuticals, including therapeutic antibodies
    • 1:CAS:528:DC%2BD2sXjs1Ontbw%3D 17395094
    • Dixit R, Boelsterli UA. Healthy animals and animal models of human disease(s) in safety assessment of human pharmaceuticals, including therapeutic antibodies. Drug Discov Today. 2007;12(7-8):336-42.
    • (2007) Drug Discov Today , vol.12 , Issue.7-8 , pp. 336-342
    • Dixit, R.1    Boelsterli, U.A.2
  • 99
    • 33644827201 scopus 로고    scopus 로고
    • Food and Drug Administration Accessed 21 March 2013
    • Food and Drug Administration. Guidance for Industry, Investigations and reviewers. Exploratory IND studies; 2006. http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM078933.pdf (Accessed 21 March 2013).
    • (2006) Guidance for Industry, Investigations and Reviewers. Exploratory IND Studies
  • 100
    • 0030993661 scopus 로고    scopus 로고
    • Hepatotoxicity in drug development: Detection, significance and solutions
    • 1:CAS:528:DyaK2sXkt1Ont7s%3D 9204407
    • Ballet F. Hepatotoxicity in drug development: detection, significance and solutions. J Hepatol. 1997;26(suppl 2):26-36.
    • (1997) J Hepatol , vol.26 , Issue.SUPPL. 2 , pp. 26-36
    • Ballet, F.1
  • 101
    • 79956321442 scopus 로고    scopus 로고
    • Pharmacological mechanism-based drug safety assessment and prediction
    • 1:STN:280:DC%2BC3MrjtFyjtg%3D%3D 21490594
    • Abernethy DR, Woodcock J, Lesko LJ. Pharmacological mechanism-based drug safety assessment and prediction. Clin Pharmacol Ther. 2011;89(6):793-7.
    • (2011) Clin Pharmacol Ther , vol.89 , Issue.6 , pp. 793-797
    • Abernethy, D.R.1    Woodcock, J.2    Lesko, L.J.3
  • 102
    • 79952764705 scopus 로고    scopus 로고
    • Drug-induced idiosyncratic hepatotoxicity: Prevention strategy developed after the troglitazone case
    • 1:CAS:528:DC%2BC3MXls1Ortb8%3D 21178300
    • Ikeda T. Drug-induced idiosyncratic hepatotoxicity: prevention strategy developed after the troglitazone case. Drug Metab Pharmacokinet. 2011;26(1):60-70.
    • (2011) Drug Metab Pharmacokinet , vol.26 , Issue.1 , pp. 60-70
    • Ikeda, T.1
  • 103
    • 77952552373 scopus 로고    scopus 로고
    • The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity
    • 1:CAS:528:DC%2BC3cXlsFahtrc%3D 20219512
    • Amacher DE. The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity. Toxicol Appl Pharmacol. 2010;245(1):134-42.
    • (2010) Toxicol Appl Pharmacol , vol.245 , Issue.1 , pp. 134-142
    • Amacher, D.E.1
  • 104
    • 80052827182 scopus 로고    scopus 로고
    • In vitro transcriptomic prediction of hepatotoxicity for early drug discovery
    • 1:CAS:528:DC%2BC3MXhtlKkt7zP
    • Cheng F, Theodorescu D, Shulman I, Lee J. In vitro transcriptomic prediction of hepatotoxicity for early drug discovery. J Theoret Biol. 2011;290:27-36.
    • (2011) J Theoret Biol , vol.290 , pp. 27-36
    • Cheng, F.1    Theodorescu, D.2    Shulman, I.3    Lee, J.4
  • 105
    • 77955919042 scopus 로고    scopus 로고
    • The application of metabonomics to predict drug-induced liver injury
    • 20668441
    • O'Connell TM, Watkins PB. The application of metabonomics to predict drug-induced liver injury. Clin Pharmacol Ther. 2010;88(3):394-9.
    • (2010) Clin Pharmacol Ther , vol.88 , Issue.3 , pp. 394-399
    • O'Connell, T.M.1    Watkins, P.B.2
  • 106
    • 79952346802 scopus 로고    scopus 로고
    • The role of metabonomics at the interface between drug metabolism and safety assessment
    • 1:CAS:528:DC%2BC3cXhs1artrfF 20973758
    • Waters NJ. The role of metabonomics at the interface between drug metabolism and safety assessment. Curr Drug Metab. 2010;11(8):686-92.
    • (2010) Curr Drug Metab , vol.11 , Issue.8 , pp. 686-692
    • Waters, N.J.1
  • 107
    • 79958019157 scopus 로고    scopus 로고
    • Toward preclinical predictive drug testing for metabolism and hepatotoxicity by using in vitro models derived from human embryonic stem cells and human cell lines - A report of the Vitrocellomics EU-project
    • 1:CAS:528:DC%2BC3MXnsl2nsr0%3D 21639679
    • Mandenius C, Andersson T, Alves P, et al. Toward preclinical predictive drug testing for metabolism and hepatotoxicity by using in vitro models derived from human embryonic stem cells and human cell lines - a report of the Vitrocellomics EU-project. Altern Lab Anim. 2011;39(2):147-71.
    • (2011) Altern Lab Anim , vol.39 , Issue.2 , pp. 147-171
    • Mandenius, C.1    Andersson, T.2    Alves, P.3
  • 108
    • 84857684723 scopus 로고    scopus 로고
    • Proteomics in the search for mechanisms and biomarkers of drug-induced hepatotoxicity
    • 22274661
    • Van Summeren A, Renes J, van Delft J, et al. Proteomics in the search for mechanisms and biomarkers of drug-induced hepatotoxicity. Toxicol In Vitro. 2012;26(3):373-85.
    • (2012) Toxicol in Vitro , vol.26 , Issue.3 , pp. 373-385
    • Van Summeren, A.1    Renes, J.2    Van Delft, J.3
  • 109
    • 84875081343 scopus 로고    scopus 로고
    • Stem cell-derived hepatocytes as a predictive model for drug-induced liver injury: Are we there yet?
    • 22703588
    • Kia R, Sison RL, Heslop J, et al. Stem cell-derived hepatocytes as a predictive model for drug-induced liver injury: are we there yet? Br J Clin Pharmacol. 2013;75(4):885-96.
    • (2013) Br J Clin Pharmacol , vol.75 , Issue.4 , pp. 885-896
    • Kia, R.1    Sison, R.L.2    Heslop, J.3
  • 110
    • 80051727852 scopus 로고    scopus 로고
    • Predicting drug-induced hepatotoxicity using QSAR and toxigenomics approaches
    • 1:CAS:528:DC%2BC3MXptVOjt7s%3D 21699217
    • Low Y, Uehara T, Minowa Y, et al. Predicting drug-induced hepatotoxicity using QSAR and toxigenomics approaches. Chem Res Toxicol. 2011;24(8):1251-62.
    • (2011) Chem Res Toxicol , vol.24 , Issue.8 , pp. 1251-1262
    • Low, Y.1    Uehara, T.2    Minowa, Y.3
  • 111
    • 36348960223 scopus 로고    scopus 로고
    • Prediction and classification of drug toxicity using probabilistic modeling of temporal metabolic data: The consortium on metabonomic toxicology screening approach
    • 1:CAS:528:DC%2BD2sXhtFWgu77N
    • Ebbels TM, Keun HC, Beckonert OP, et al. Prediction and classification of drug toxicity using probabilistic modeling of temporal metabolic data: the consortium on metabonomic toxicology screening approach. J Proteosome Res. 2007;6(11):4407-22.
    • (2007) J Proteosome Res , vol.6 , Issue.11 , pp. 4407-4422
    • Ebbels, T.M.1    Keun, H.C.2    Beckonert, O.P.3
  • 112
    • 84856085169 scopus 로고    scopus 로고
    • In silico models for drug-induced liver injury - Current status
    • 1:CAS:528:DC%2BC38XhtV2itLs%3D 22248266
    • Przybylak KR, Cronin MT. In silico models for drug-induced liver injury - current status. Expert Opin Drug Metab Toxicol. 2012;8(2):201-17.
    • (2012) Expert Opin Drug Metab Toxicol , vol.8 , Issue.2 , pp. 201-217
    • Przybylak, K.R.1    Cronin, M.T.2
  • 113
    • 62749161471 scopus 로고    scopus 로고
    • The liver toxicity biomarker study: Phase design and preliminary results
    • 1:CAS:528:DC%2BD1MXjtVyisLs%3D 19171931
    • McBurney RN, Hines W, Von Tungelin LS, et al. The liver toxicity biomarker study: phase design and preliminary results. Toxicol Pathol. 2009;37(1):52-64.
    • (2009) Toxicol Pathol , vol.37 , Issue.1 , pp. 52-64
    • McBurney, R.N.1    Hines, W.2    Von Tungelin, L.S.3
  • 114
    • 80053004364 scopus 로고    scopus 로고
    • Structural alert/reactive metabolite concept as applied in medicinal chemistry to mitigate the risk of idiosyncratic drug toxicity: A perspective based on the critical examination of trends in the top 200 drugs marketed in the Unites States
    • 1:CAS:528:DC%2BC3MXos1Whtbo%3D 21702456
    • Stepan A, Walker D, Bauman J, Price D, et al. Structural alert/reactive metabolite concept as applied in medicinal chemistry to mitigate the risk of idiosyncratic drug toxicity: a perspective based on the critical examination of trends in the top 200 drugs marketed in the Unites States. Chem Res Toxicol. 2011;24(9):1345-410.
    • (2011) Chem Res Toxicol , vol.24 , Issue.9 , pp. 1345-1410
    • Stepan, A.1    Walker, D.2    Bauman, J.3    Price, D.4
  • 115
    • 70350273017 scopus 로고    scopus 로고
    • Structural alerts, reactive metabolites, and protein covalent binding: How reliable are these attributes as predictors of drug toxicity?
    • 1:CAS:528:DC%2BD1MXhsFSrtL%2FL 19937848
    • Kalgutkar AS, Didiuk MT. Structural alerts, reactive metabolites, and protein covalent binding: how reliable are these attributes as predictors of drug toxicity? Chem Biodivers. 2009;6(11):2115-37.
    • (2009) Chem Biodivers , vol.6 , Issue.11 , pp. 2115-2137
    • Kalgutkar, A.S.1    Didiuk, M.T.2
  • 116
    • 79957971588 scopus 로고    scopus 로고
    • Small molecule databases and chemical descriptors useful in chemoinformatics: An overview
    • Gonzalbes R, Pineda-Lucena A. Small molecule databases and chemical descriptors useful in chemoinformatics: an overview. Comb Chem Throughput Screen. 2011;14(6):548.
    • (2011) Comb Chem Throughput Screen , vol.14 , Issue.6 , pp. 548
    • Gonzalbes, R.1    Pineda-Lucena, A.2
  • 117
    • 77950508162 scopus 로고    scopus 로고
    • Biomarkers for drug-induced liver injury
    • 1:CAS:528:DC%2BC3cXjvF2hsL8%3D 20350268
    • Shi Q, Hong H, Senior J, et al. Biomarkers for drug-induced liver injury. Expert Rev Gastroenterol Hepatol. 2010;4(2):225-34.
    • (2010) Expert Rev Gastroenterol Hepatol , vol.4 , Issue.2 , pp. 225-234
    • Shi, Q.1    Hong, H.2    Senior, J.3
  • 118
    • 84867027478 scopus 로고    scopus 로고
    • The determination and interpretation of the therapeutic index in drug development
    • 1:CAS:528:DC%2BC38Xht1ynt7vL 22935759
    • Muller PY, Milton MN. The determination and interpretation of the therapeutic index in drug development. Nat Rev Drug Discov. 2012;11(10):751-61.
    • (2012) Nat Rev Drug Discov , vol.11 , Issue.10 , pp. 751-761
    • Muller, P.Y.1    Milton, M.N.2
  • 119
    • 68749083601 scopus 로고    scopus 로고
    • A framework to assess the translation of safety pharmacology data to humans
    • 1:CAS:528:DC%2BD1MXhsVahsLbJ 19616110
    • Valentin JP, Bialecki R, Ewart L, et al. A framework to assess the translation of safety pharmacology data to humans. J Pharmacol Toxicol Methods. 2009;60(2):152-8.
    • (2009) J Pharmacol Toxicol Methods , vol.60 , Issue.2 , pp. 152-158
    • Valentin, J.P.1    Bialecki, R.2    Ewart, L.3
  • 120
    • 79956321804 scopus 로고    scopus 로고
    • Drug safety sciences and the bottleneck in drug development
    • 1:STN:280:DC%2BC3MrjtlWqtw%3D%3D 21593756
    • Watkins PB. Drug safety sciences and the bottleneck in drug development. Clin Pharmacol Ther. 2011;89(6):788-90.
    • (2011) Clin Pharmacol Ther , vol.89 , Issue.6 , pp. 788-790
    • Watkins, P.B.1
  • 121
    • 1542349815 scopus 로고    scopus 로고
    • Hy's law
    • 14768020
    • Reuben A. Hy's law. Hepatology. 2004;39(2):574-8.
    • (2004) Hepatology , vol.39 , Issue.2 , pp. 574-578
    • Reuben, A.1
  • 123
    • 33646048007 scopus 로고    scopus 로고
    • 'Hy's law', 'the Rezulin Rule' and other predictors of severe drug-induced hepatotoxicity: Putting risk-benefit into perspective
    • 1:CAS:528:DC%2BD28XkvFGms74%3D 16444771
    • Lewis JH. 'Hy's law', 'the Rezulin Rule' and other predictors of severe drug-induced hepatotoxicity: putting risk-benefit into perspective. Pharmacoepidemiol Drug Saf. 2006;15(4):221-9.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , Issue.4 , pp. 221-229
    • Lewis, J.H.1
  • 124
    • 33646052267 scopus 로고    scopus 로고
    • Rules and laws of drug hepatotoxicity
    • 1:CAS:528:DC%2BD28XkvFGms78%3D 16552791
    • Kaplowitz N. Rules and laws of drug hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15(4):231-3.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , Issue.4 , pp. 231-233
    • Kaplowitz, N.1
  • 125
    • 18744376412 scopus 로고    scopus 로고
    • Drug-induced liver injury: An analysis of 461 incidences submitted to the Spanish registry over a 10-year period
    • 16083708
    • Andrade RL, Lucena MI, Fernandez MC, et al. Drug-induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10-year period. Gastroenterology. 2005;129(2):512-21.
    • (2005) Gastroenterology , vol.129 , Issue.2 , pp. 512-521
    • Andrade, R.L.1    Lucena, M.I.2    Fernandez, M.C.3
  • 126
    • 23044473682 scopus 로고    scopus 로고
    • Outcome and prognostic markers to severe drug-induced liver disease
    • 16025496
    • Bjornsson E, Olsson R. Outcome and prognostic markers to severe drug-induced liver disease. Hepatology. 2005;42(2):481-9.
    • (2005) Hepatology , vol.42 , Issue.2 , pp. 481-489
    • Bjornsson, E.1    Olsson, R.2
  • 127
    • 57249086242 scopus 로고    scopus 로고
    • Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States
    • 18955056
    • Chalasani N, Fontana RJ, Bonjovsky HL, et al. Causes, clinical features, and outcomes from a prospective study of drug-induced liver injury in the United States. Gastroenterology. 2008;135(6):1924-34.
    • (2008) Gastroenterology , vol.135 , Issue.6 , pp. 1924-1934
    • Chalasani, N.1    Fontana, R.J.2    Bonjovsky, H.L.3
  • 128
    • 78149280101 scopus 로고    scopus 로고
    • Single-center experience with drug-induced liver injury from India: Causes, outcome, prognosis, and predictors of mortality
    • 20648003
    • Devarbhavi H, Dierkhising R, Kremers W, et al. Single-center experience with drug-induced liver injury from India: causes, outcome, prognosis, and predictors of mortality. Am J Gastroenterol. 2010;105(11):2396-404.
    • (2010) Am J Gastroenterol , vol.105 , Issue.11 , pp. 2396-2404
    • Devarbhavi, H.1    Dierkhising, R.2    Kremers, W.3
  • 129
    • 0008842794 scopus 로고    scopus 로고
    • Management of drug-induced liver disease
    • 1:STN:280:DC%2BD38%2Fgs1ylsA%3D%3D 11177693
    • Marino G, Zimmerman HJ, Lewis JH. Management of drug-induced liver disease. Curr Gastroenterol Rep. 2001;3(1):38-48.
    • (2001) Curr Gastroenterol Rep , vol.3 , Issue.1 , pp. 38-48
    • Marino, G.1    Zimmerman, H.J.2    Lewis, J.H.3
  • 131
    • 77952780806 scopus 로고    scopus 로고
    • The existence of a relationship between increased serum alanine aminotransferase levels detected in premarketing clinical trials and postmarketing published hepatotoxicity case reports
    • 1:CAS:528:DC%2BC3cXosFejtr0%3D 20331578
    • Llanos L, Moreu R, Ortin T, et al. The existence of a relationship between increased serum alanine aminotransferase levels detected in premarketing clinical trials and postmarketing published hepatotoxicity case reports. Aliment Pharmacol Ther. 2010;31(12):1337-45.
    • (2010) Aliment Pharmacol Ther , vol.31 , Issue.12 , pp. 1337-1345
    • Llanos, L.1    Moreu, R.2    Ortin, T.3
  • 132
    • 17444396697 scopus 로고    scopus 로고
    • Hepatic findings in long-term clinical trials of ximelagatran
    • 1:CAS:528:DC%2BD2MXktFymt7k%3D 15783243
    • Lee WM, Larrey D, Olsson R, et al. Hepatic findings in long-term clinical trials of ximelagatran. Drug Saf. 2005;28(4):351-70.
    • (2005) Drug Saf , vol.28 , Issue.4 , pp. 351-370
    • Lee, W.M.1    Larrey, D.2    Olsson, R.3
  • 133
    • 0032831519 scopus 로고    scopus 로고
    • Acute liver injury associated with the use of ebrotidine, a new H2-receptor antagonist
    • 1:CAS:528:DyaK1MXntlWlsL0%3D 10551387
    • Andrade RJ, Lucena MI, Martin-Vivaldi R, et al. Acute liver injury associated with the use of ebrotidine, a new H2-receptor antagonist. J Hepatol. 1999;31(4):641-6.
    • (1999) J Hepatol , vol.31 , Issue.4 , pp. 641-646
    • Andrade, R.J.1    Lucena, M.I.2    Martin-Vivaldi, R.3
  • 134
    • 77955082302 scopus 로고    scopus 로고
    • A genome-wide study identifies HLA alleles associated with lumiracoxib-related liver injury
    • 1:CAS:528:DC%2BC3cXovFCgur4%3D 20639878
    • Singer JB, Lewitzky S, Leroy E, et al. A genome-wide study identifies HLA alleles associated with lumiracoxib-related liver injury. Nat Genet. 2010;42(8):711-1471.
    • (2010) Nat Genet , vol.42 , Issue.8 , pp. 711-1471
    • Singer, J.B.1    Lewitzky, S.2    Leroy, E.3
  • 136
    • 0029101794 scopus 로고
    • Probability of adverse events that have not yet occurred: A statistical reminder
    • 1:STN:280:DyaK2Mzpt1ejsA%3D%3D 7663258
    • Eypasch E, Leferinga R, Kuma CK, et al. Probability of adverse events that have not yet occurred: a statistical reminder. BMJ. 1995;311:619.
    • (1995) BMJ , vol.311 , pp. 619
    • Eypasch, E.1    Leferinga, R.2    Kuma, C.K.3
  • 137
    • 84866132802 scopus 로고    scopus 로고
    • Validation of multivariate outlier detection analyses used to identify potential drug-induced liver injury in clinical trial populations
    • 22928730
    • Lin X, Parks D, Painter J, et al. Validation of multivariate outlier detection analyses used to identify potential drug-induced liver injury in clinical trial populations. Drug Saf. 2012;35(10):865-75.
    • (2012) Drug Saf , vol.35 , Issue.10 , pp. 865-875
    • Lin, X.1    Parks, D.2    Painter, J.3
  • 138
    • 79951784125 scopus 로고    scopus 로고
    • Evaluation of drug-induced serious hepatotoxicity (eDISH): Application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery
    • 21332248
    • Watkins PB, Desai M, Berkowitz SD, et al. Evaluation of drug-induced serious hepatotoxicity (eDISH): application of this data organization approach to phase III clinical trials of rivaroxaban after total hip or knee replacement surgery. Drug Saf. 2011;34(3):243-52.
    • (2011) Drug Saf , vol.34 , Issue.3 , pp. 243-252
    • Watkins, P.B.1    Desai, M.2    Berkowitz, S.D.3
  • 139
    • 84864416628 scopus 로고    scopus 로고
    • An integrated analysis of liver safety data from orlistat clinical trials
    • 22854341
    • Morris M, Lane P, Lee K, et al. An integrated analysis of liver safety data from orlistat clinical trials. Obes Facts. 2012;5(4):485-94.
    • (2012) Obes Facts , vol.5 , Issue.4 , pp. 485-494
    • Morris, M.1    Lane, P.2    Lee, K.3
  • 140
    • 84862506346 scopus 로고    scopus 로고
    • The adaptive response (drug tolerance) helps prevent drug-induced liver disease
    • Lewis JH. The adaptive response (drug tolerance) helps prevent drug-induced liver disease. Gastroenterol Hepatol. 2012;8(5):333-6.
    • (2012) Gastroenterol Hepatol , vol.8 , Issue.5 , pp. 333-336
    • Lewis, J.H.1
  • 141
    • 77954069495 scopus 로고    scopus 로고
    • Mechanisms of immune-mediated liver injury
    • 1:CAS:528:DC%2BC3cXmsVGnu7Y%3D 20071422
    • Adams DH, Ju C, Ramaiah SK, et al. Mechanisms of immune-mediated liver injury. Toxicol Sci. 2010;115(2):307-21.
    • (2010) Toxicol Sci , vol.115 , Issue.2 , pp. 307-321
    • Adams, D.H.1    Ju, C.2    Ramaiah, S.K.3
  • 142
    • 33947159213 scopus 로고    scopus 로고
    • Role of IL-6 in an IL-10 and IL-4 double knockout mouse model uniquely susceptible to acetaminophen-induced liver injury
    • 1:CAS:528:DC%2BD2sXitFGktQ%3D%3D 17305405
    • Bourdi M, Eiras DP, Holt MP, et al. Role of IL-6 in an IL-10 and IL-4 double knockout mouse model uniquely susceptible to acetaminophen-induced liver injury. Chem Res Toxicol. 2007;20(2):208-16.
    • (2007) Chem Res Toxicol , vol.20 , Issue.2 , pp. 208-216
    • Bourdi, M.1    Eiras, D.P.2    Holt, M.P.3
  • 143
    • 0028316959 scopus 로고
    • Hepatotoxic effects of tacrine administration in patients with Alzheimer's disease
    • 1:CAS:528:DyaK2cXlt1Gjs7c%3D 8139084
    • Watkins PB, Zimmerman HJ, Knapp MJ, et al. Hepatotoxic effects of tacrine administration in patients with Alzheimer's disease. JAMA. 1994;271(13):992-8.
    • (1994) JAMA , vol.271 , Issue.13 , pp. 992-998
    • Watkins, P.B.1    Zimmerman, H.J.2    Knapp, M.J.3
  • 144
    • 34548311561 scopus 로고    scopus 로고
    • Clinical pattern of zileuton-associated liver injury: Results of a 12-month study in patients with chronic asthma
    • 1:CAS:528:DC%2BD2sXht1amsb%2FJ 17722971
    • Watkins PB, Dube LM, Walton-Bowen K, et al. Clinical pattern of zileuton-associated liver injury: results of a 12-month study in patients with chronic asthma. Drug Saf. 2007;30(9):805-15.
    • (2007) Drug Saf , vol.30 , Issue.9 , pp. 805-815
    • Watkins, P.B.1    Dube, L.M.2    Walton-Bowen, K.3
  • 145
    • 65549123241 scopus 로고    scopus 로고
    • Compliance to recommended liver function monitoring in patients on statin therapy
    • 19426246
    • Leaver H, Keng Lim T, Thompson P, et al. Compliance to recommended liver function monitoring in patients on statin therapy. Cardiovasc Ther. 2009;27(2):96-100.
    • (2009) Cardiovasc Ther , vol.27 , Issue.2 , pp. 96-100
    • Leaver, H.1    Keng Lim, T.2    Thompson, P.3
  • 146
    • 77951944375 scopus 로고    scopus 로고
    • The myth of statin-induced hepatotoxicity
    • 20445507
    • Bader T. The myth of statin-induced hepatotoxicity. Am J Gastroenterol. 2010;105(5):978-80.
    • (2010) Am J Gastroenterol , vol.105 , Issue.5 , pp. 978-980
    • Bader, T.1
  • 148
    • 0035880320 scopus 로고    scopus 로고
    • Liver enzyme monitoring in patients treated with troglitazone
    • 1:CAS:528:DC%2BD3MXms1WjtLo%3D 11497537
    • Graham D, Drinkard C, Shatin D, Tsong Y, et al. Liver enzyme monitoring in patients treated with troglitazone. JAMA. 2001;286(7):831-3.
    • (2001) JAMA , vol.286 , Issue.7 , pp. 831-833
    • Graham, D.1    Drinkard, C.2    Shatin, D.3    Tsong, Y.4
  • 149
    • 15444380375 scopus 로고    scopus 로고
    • Safety in numbers - Monitoring risk in approved drugs
    • 1:CAS:528:DC%2BD2MXisFShs7g%3D 15788493
    • Okie S. Safety in numbers - monitoring risk in approved drugs. N Engl J Med. 2005;352(12):1173-6.
    • (2005) N Engl J Med , vol.352 , Issue.12 , pp. 1173-1176
    • Okie, S.1
  • 150
    • 64349088125 scopus 로고    scopus 로고
    • Successful translation of pharmacogenetics into the clinic: The abacavir example
    • 19351209
    • Phillips E, Mallal S. Successful translation of pharmacogenetics into the clinic: the abacavir example. Mol Diagn Ther. 2009;13(1):1-9.
    • (2009) Mol Diagn Ther , vol.13 , Issue.1 , pp. 1-9
    • Phillips, E.1    Mallal, S.2
  • 151
    • 53549099386 scopus 로고    scopus 로고
    • Review article: The use of potentially hepatotoxic drugs in patients with liver disease
    • 1:CAS:528:DC%2BD1cXhsVemsbbP 18671777
    • Gupta N, Lewis JH. Review article: The use of potentially hepatotoxic drugs in patients with liver disease. Aliment Pharmacol Ther. 2008;28(9):1021-41.
    • (2008) Aliment Pharmacol Ther , vol.28 , Issue.9 , pp. 1021-1041
    • Gupta, N.1    Lewis, J.H.2
  • 154
    • 36348987648 scopus 로고    scopus 로고
    • Safety and efficacy of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease. Results of a prospective, randomized, double-blind, placebo-controlled trial
    • 1:CAS:528:DC%2BD2sXhtlOiu7bM 17668878
    • Lewis JH, Mortensen ME, Zweig S, et al. Safety and efficacy of high-dose pravastatin in hypercholesterolemic patients with well-compensated chronic liver disease. Results of a prospective, randomized, double-blind, placebo-controlled trial. Hepatology. 2007;46(5):1453-63.
    • (2007) Hepatology , vol.46 , Issue.5 , pp. 1453-1463
    • Lewis, J.H.1    Mortensen, M.E.2    Zweig, S.3
  • 155
    • 79960149216 scopus 로고    scopus 로고
    • 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)
    • 21539883
    • M'Kada H, Munteanu M, Perazzo H, et al. 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). Regul Toxicol Pharmacol. 2011;60(3):290-5.
    • (2011) Regul Toxicol Pharmacol , vol.60 , Issue.3 , pp. 290-295
    • M'Kada, H.1    Munteanu, M.2    Perazzo, H.3
  • 156
    • 0037008087 scopus 로고    scopus 로고
    • Updated definitions of healthy ranges for serum alanine aminotransferase levels
    • 1:CAS:528:DC%2BD38Xls1entbc%3D 12093239
    • Prati D, Taioli E, Zanella A, et al. Updated definitions of healthy ranges for serum alanine aminotransferase levels. Ann Intern Med. 2002;137(1):1-10.
    • (2002) Ann Intern Med , vol.137 , Issue.1 , pp. 1-10
    • Prati, D.1    Taioli, E.2    Zanella, A.3
  • 157
    • 84866038356 scopus 로고    scopus 로고
    • Upper limits of normal for serum alanine aminotransferase levels in Chinese Han population
    • 1:CAS:528:DC%2BC38XhtlahtLbI 22962588
    • Zheng MH, Shi KQ, Fan YC, et al. Upper limits of normal for serum alanine aminotransferase levels in Chinese Han population. PLoS One. 2012;7(9):e43736.
    • (2012) PLoS One , vol.7 , Issue.9 , pp. 43736
    • Zheng, M.H.1    Shi, K.Q.2    Fan, Y.C.3
  • 158
    • 27744544502 scopus 로고    scopus 로고
    • Correlation between serum alanine aminotransferase activity and age: An inverted U curve pattern
    • 16181369
    • Elinav E, Ben-Dov IZ, Ackerman E, et al. Correlation between serum alanine aminotransferase activity and age: an inverted U curve pattern. Am J Gastroenterol. 2005;100(10):2201-4.
    • (2005) Am J Gastroenterol , vol.100 , Issue.10 , pp. 2201-2204
    • Elinav, E.1    Ben-Dov, I.Z.2    Ackerman, E.3
  • 159
    • 84857189403 scopus 로고    scopus 로고
    • Serum levels of alanine aminotransferase decrease with age in longitudinal analysis
    • 1:CAS:528:DC%2BC38XislSqtbw%3D 22020064
    • Dong MH, Bettencourt R, Brenner DA, et al. Serum levels of alanine aminotransferase decrease with age in longitudinal analysis. Clin Gastroenterol Hepatol. 2012;10(3):285-90.
    • (2012) Clin Gastroenterol Hepatol , vol.10 , Issue.3 , pp. 285-290
    • Dong, M.H.1    Bettencourt, R.2    Brenner, D.A.3
  • 161
    • 13444273562 scopus 로고    scopus 로고
    • Recognizing drug-induced liver injury: Current problems, possible solutions
    • 1:CAS:528:DC%2BD2MXhtFaqu7k%3D 15805067
    • Lee WM, Senior JR. Recognizing drug-induced liver injury: current problems, possible solutions. Toxicol Pathol. 2005;33(1):155-64.
    • (2005) Toxicol Pathol , vol.33 , Issue.1 , pp. 155-164
    • Lee, W.M.1    Senior, J.R.2
  • 162
    • 0033547542 scopus 로고    scopus 로고
    • Accuracy of hepatic adverse drug reaction reporting in one English health region
    • Aithal GP, Rawlins MD, Day CP. Accuracy of hepatic adverse drug reaction reporting in one English health region. BMJ. 1999;319(11):1541.
    • (1999) BMJ , vol.319 , Issue.11 , pp. 1541
    • Aithal, G.P.1    Rawlins, M.D.2    Day, C.P.3
  • 163
    • 0035192830 scopus 로고    scopus 로고
    • Causality assessment versus guilt-by-association in drug hepatotoxicity
    • 1:STN:280:DC%2BD3M%2FpvFSitw%3D%3D 11124850
    • Kaplowitz N. Causality assessment versus guilt-by-association in drug hepatotoxicity. Hepatology. 2001;33(1):308-10.
    • (2001) Hepatology , vol.33 , Issue.1 , pp. 308-310
    • Kaplowitz, N.1
  • 164
    • 0027362542 scopus 로고
    • Causality assessment of adverse reactions to drugs - I. A novel method based on the conclusions of international consensus meetings: Application to drug-induced liver injuries
    • 1:STN:280:DyaK2c%2FksFOquw%3D%3D 8229110
    • Danan G, Benichou C. Causality assessment of adverse reactions to drugs - I. A novel method based on the conclusions of international consensus meetings: application to drug-induced liver injuries. J Clin Epidemiol. 1993;46(11):1323-30.
    • (1993) J Clin Epidemiol , vol.46 , Issue.11 , pp. 1323-1330
    • Danan, G.1    Benichou, C.2
  • 165
    • 0027448634 scopus 로고
    • Causality assessment of adverse reactions to drugs - II. An original model for validation of drug causality assessment methods: Case reports with positive rechallenge
    • 1:STN:280:DyaK2c%2FksFyjsg%3D%3D 8229111
    • Benichou C, Danan G, Flahault A. Causality assessment of adverse reactions to drugs - II. An original model for validation of drug causality assessment methods: case reports with positive rechallenge. J Clin Epidemiol. 1993;46(11):1331-6.
    • (1993) J Clin Epidemiol , vol.46 , Issue.11 , pp. 1331-1336
    • Benichou, C.1    Danan, G.2    Flahault, A.3
  • 166
    • 0033661511 scopus 로고    scopus 로고
    • Clinical diagnostic scale: A useful tool in the evaluation of suspected hepatotoxic adverse drug reactions
    • 1:CAS:528:DC%2BD3cXovVKjsbw%3D 11131457
    • Aithal GP, Rawlins MD, Day CP. Clinical diagnostic scale: a useful tool in the evaluation of suspected hepatotoxic adverse drug reactions. J Hepatol. 2000;33(6):949-52.
    • (2000) J Hepatol , vol.33 , Issue.6 , pp. 949-952
    • Aithal, G.P.1    Rawlins, M.D.2    Day, C.P.3
  • 167
    • 0030865914 scopus 로고    scopus 로고
    • Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis
    • 1:STN:280:DyaK2svkslOmtQ%3D%3D 9303497
    • Maria VAJ, Victorino RMM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology. 1997;26(3):664-9.
    • (1997) Hepatology , vol.26 , Issue.3 , pp. 664-669
    • Maria, V.A.J.1    Victorino, R.M.M.2
  • 168
    • 0035200244 scopus 로고    scopus 로고
    • Comparison of two clinical scales for causality assessment in hepatotoxicity
    • 1:CAS:528:DC%2BD3MXktFWqsQ%3D%3D 11124828
    • Lucena M, Camargo R, Andrade R, et al. Comparison of two clinical scales for causality assessment in hepatotoxicity. Hepatology. 2001;33(1):123-30.
    • (2001) Hepatology , vol.33 , Issue.1 , pp. 123-130
    • Lucena, M.1    Camargo, R.2    Andrade, R.3
  • 169
    • 34548124521 scopus 로고    scopus 로고
    • Causality assessment of drug-induced liver disease. Promises and pitfalls
    • 17723916
    • Shapiro M, Lewis JH. Causality assessment of drug-induced liver disease. Promises and pitfalls. Clin Liver Dis. 2007;11(3):477-505.
    • (2007) Clin Liver Dis , vol.11 , Issue.3 , pp. 477-505
    • Shapiro, M.1    Lewis, J.H.2
  • 170
    • 79956295350 scopus 로고    scopus 로고
    • Case definition and phenotype standardization in drug-induced liver injury
    • 1:CAS:528:DC%2BC3MXmtlagtrg%3D 21544079
    • Aithal GP, Watkins PB, Andrade RJ, et al. Case definition and phenotype standardization in drug-induced liver injury. Clin Pharmacol Ther. 2011;89(6):806-15.
    • (2011) Clin Pharmacol Ther , vol.89 , Issue.6 , pp. 806-815
    • Aithal, G.P.1    Watkins, P.B.2    Andrade, R.J.3
  • 171
    • 0018423801 scopus 로고
    • Judgments of trained observers on adverse drug reactions
    • 1:STN:280:DyaE1M7mvVWnsQ%3D%3D 436353
    • Blanc S, Leuenberger P, Berger J-P, et al. Judgments of trained observers on adverse drug reactions. Clin Pharmacol Ther. 1979;25(5):493-8.
    • (1979) Clin Pharmacol Ther , vol.25 , Issue.5 , pp. 493-498
    • Blanc, S.1    Leuenberger, P.2    Berger, J.-P.3
  • 172
    • 84862015812 scopus 로고    scopus 로고
    • Suspected herbal hepatotoxicity: Requirements for appropriate causality assessment by the US Pharmacopeia
    • 22897137
    • Teschke R, Schulze J. Suspected herbal hepatotoxicity: requirements for appropriate causality assessment by the US Pharmacopeia. Drug Saf. 2012;35(12):1091-7.
    • (2012) Drug Saf , vol.35 , Issue.12 , pp. 1091-1097
    • Teschke, R.1    Schulze, J.2
  • 173
    • 47549098648 scopus 로고    scopus 로고
    • Utility of the Roussel Uclaf Causality Assessment Method (RUCAM) to analyze the hepatic findings in a clinical trial program: Evaluation of the direct thrombin inhibitor ximelagatran
    • 1:CAS:528:DC%2BD1cXhtVynu7fK 18793587
    • Lewis JH, Larrey D, Olsson R, et al. Utility of the Roussel Uclaf Causality Assessment Method (RUCAM) to analyze the hepatic findings in a clinical trial program: evaluation of the direct thrombin inhibitor ximelagatran. Int J Clin Pharmacol Ther. 2008;46(7):327-39.
    • (2008) Int J Clin Pharmacol Ther , vol.46 , Issue.7 , pp. 327-339
    • Lewis, J.H.1    Larrey, D.2    Olsson, R.3
  • 174
    • 77952702755 scopus 로고    scopus 로고
    • Causality assessment in drug-induced liver injury using a structured expert opinion process: Comparison to the Roussel-Uclaf Causality Assessment Method
    • 20512999
    • Rockey DC, Seeff LB, Rochon J, et al. Causality assessment in drug-induced liver injury using a structured expert opinion process: comparison to the Roussel-Uclaf Causality Assessment Method. Hepatology. 2010;51(6):2117-26.
    • (2010) Hepatology , vol.51 , Issue.6 , pp. 2117-2126
    • Rockey, D.C.1    Seeff, L.B.2    Rochon, J.3
  • 175
    • 77955670653 scopus 로고    scopus 로고
    • Standardization of nomenclature and causality assessment in drug-induced liver injury: Summary of a clinical research workshop
    • Fontana RJ, Seeff LB, Andrade RJ, et al. Standardization of nomenclature and causality assessment in drug-induced liver injury: summary of a clinical research workshop. Hepatology. 2010;52(2):737-42.
    • (2010) Hepatology , vol.52 , Issue.2 , pp. 737-742
    • Fontana, R.J.1    Seeff, L.B.2    Andrade, R.J.3
  • 176
    • 13944261620 scopus 로고    scopus 로고
    • Marked elevation in serum transaminases: An atypical presentation of choledocholithiasis
    • 1:CAS:528:DC%2BD2MXisVeit7c%3D 15667485
    • Nathwani RA, Kumar SR, Reynolds TB, et al. Marked elevation in serum transaminases: an atypical presentation of choledocholithiasis. Am J Gastroenterol. 2005;100(2):295-8.
    • (2005) Am J Gastroenterol , vol.100 , Issue.2 , pp. 295-298
    • Nathwani, R.A.1    Kumar, S.R.2    Reynolds, T.B.3
  • 177
    • 77953686686 scopus 로고    scopus 로고
    • Detective work in drug-induced liver injury: Sometimes it is all about interviewing the right witness
    • 20363371
    • Barritt AS 4th, Lee J, Hayashi PH. Detective work in drug-induced liver injury: sometimes it is all about interviewing the right witness. Clin Gastroenterol Hepatol. 2010;8(7):635-7.
    • (2010) Clin Gastroenterol Hepatol , vol.8 , Issue.7 , pp. 635-637
    • Barritt IV, A.S.1    Lee, J.2    Hayashi, P.H.3
  • 179
    • 35748961968 scopus 로고    scopus 로고
    • The role of hepatitis e virus testing in drug-induced liver injury
    • 1:STN:280:DC%2BD2snlvVSrsw%3D%3D 17850420
    • Dalton HR, Fellows HJ, Stableforth W, et al. The role of hepatitis E virus testing in drug-induced liver injury. Aliment Pharmacol Ther. 2007;26(10):1429-35.
    • (2007) Aliment Pharmacol Ther , vol.26 , Issue.10 , pp. 1429-1435
    • Dalton, H.R.1    Fellows, H.J.2    Stableforth, W.3
  • 180
    • 80054848088 scopus 로고    scopus 로고
    • Acute hepatitis e infection accounts for some cases of suspected drug-induced liver injury
    • 21855518
    • Davern TJ, Chalasani N, Fontana RJ, et al. Acute hepatitis E infection accounts for some cases of suspected drug-induced liver injury. Gastroenterology. 2011;141(5):1665-72.
    • (2011) Gastroenterology , vol.141 , Issue.5 , pp. 1665-1672
    • Davern, T.J.1    Chalasani, N.2    Fontana, R.J.3
  • 181
    • 84870513832 scopus 로고    scopus 로고
    • Hepatitis e masquerading as drug-induced liver injury
    • 23175167
    • Chen EY, Baum K, Collins W, et al. Hepatitis E masquerading as drug-induced liver injury. Hepatology. 2012;56(6):2420-3.
    • (2012) Hepatology , vol.56 , Issue.6 , pp. 2420-2423
    • Chen, E.Y.1    Baum, K.2    Collins, W.3
  • 182
    • 56149105113 scopus 로고    scopus 로고
    • Using controlled clinical trials to learn more about acute drug-induced liver injury
    • 18853438
    • Watkins PB, Seligman PJ, Pears JS, et al. Using controlled clinical trials to learn more about acute drug-induced liver injury. Hepatology. 2008;48(5):1680-9.
    • (2008) Hepatology , vol.48 , Issue.5 , pp. 1680-1689
    • Watkins, P.B.1    Seligman, P.J.2    Pears, J.S.3
  • 183
    • 84867183673 scopus 로고    scopus 로고
    • The prevention and treatment of missing clinical data in clinical trials
    • 1:CAS:528:DC%2BC38XhsFWksLjI 23034025
    • Little RJ, D'Agostino R, Cohen ML, et al. The prevention and treatment of missing clinical data in clinical trials. N Engl J Med. 2012;367(14):1355-60.
    • (2012) N Engl J Med , vol.367 , Issue.14 , pp. 1355-1360
    • Little, R.J.1    D'Agostino, R.2    Cohen, M.L.3
  • 184
    • 77950864495 scopus 로고    scopus 로고
    • Important elements for the diagnosis of drug-induced liver injury
    • for the Drug-induced Liver Injury Network 20170750
    • Agarwal VK, McHutchison JG, Hoofnagle JH, for the Drug-induced Liver Injury Network. Important elements for the diagnosis of drug-induced liver injury. Clin Gastroenterol Hepatol. 2010;8(5):463-70.
    • (2010) Clin Gastroenterol Hepatol , vol.8 , Issue.5 , pp. 463-470
    • Agarwal, V.K.1    McHutchison, J.G.2    Hoofnagle, J.H.3
  • 185
    • 79956298384 scopus 로고    scopus 로고
    • Adverse drug reactions: Moving from chance to science
    • 1:STN:280:DC%2BC3MrjtlWrtA%3D%3D 21593747
    • Haller C, James LP. Adverse drug reactions: moving from chance to science. Clin Pharmacol Ther. 2011;89(6):761-4.
    • (2011) Clin Pharmacol Ther , vol.89 , Issue.6 , pp. 761-764
    • Haller, C.1    James, L.P.2
  • 186
    • 3042609851 scopus 로고    scopus 로고
    • Using MedDRA: Implications for risk management
    • 15154830
    • Brown EG. Using MedDRA: implications for risk management. Drug Saf. 2004;27(8):591-602.
    • (2004) Drug Saf , vol.27 , Issue.8 , pp. 591-602
    • Brown, E.G.1
  • 187
    • 84862778004 scopus 로고    scopus 로고
    • Acute liver failure
    • 22447259
    • Lee WM. Acute liver failure. Semin Respir Crit Care Med. 2012;33(1):36-45.
    • (2012) Semin Respir Crit Care Med , vol.33 , Issue.1 , pp. 36-45
    • Lee, W.M.1
  • 188
    • 0026564162 scopus 로고
    • A primer of drug safety surveillance: An industry perspective. Part III: Managing adverse-event data
    • 1:STN:280:DyaK3s%2FpvVyktA%3D%3D 10122649
    • Allan MC. A primer of drug safety surveillance: an industry perspective. Part III: managing adverse-event data. J Pharm Technol. 1992;8(6):259-73.
    • (1992) J Pharm Technol , vol.8 , Issue.6 , pp. 259-273
    • Allan, M.C.1
  • 189
    • 3042653098 scopus 로고    scopus 로고
    • CIOMS and ICH initiatives in pharmacovigilance and risk management: Overview and implications
    • 15154824
    • Tsintis P, La Mache E. CIOMS and ICH initiatives in pharmacovigilance and risk management: overview and implications. Drug Saf. 2004;27(8):509-17.
    • (2004) Drug Saf , vol.27 , Issue.8 , pp. 509-517
    • Tsintis, P.1    La MacHe, E.2
  • 190
    • 38449122703 scopus 로고    scopus 로고
    • Database size and power to detect safety signals in pharmacovigilance
    • 1:CAS:528:DC%2BD2sXht1anu7%2FK 17967160
    • Hammond IW, Gibbs TG, Seifert HA, et al. Database size and power to detect safety signals in pharmacovigilance. Expert Opin Drug Saf. 2007;6(6):713-21.
    • (2007) Expert Opin Drug Saf , vol.6 , Issue.6 , pp. 713-721
    • Hammond, I.W.1    Gibbs, T.G.2    Seifert, H.A.3
  • 191
    • 40849119956 scopus 로고    scopus 로고
    • The application of knowledge discovery in databases to post-marketing drug safety: Example of the WHO database
    • 1:CAS:528:DC%2BD1cXks1ansrY%3D 18248442
    • Bate A, Lindquist M, Edwards IR. The application of knowledge discovery in databases to post-marketing drug safety: example of the WHO database. Fundam Clin Pharmacol. 2008;22(2):127-40.
    • (2008) Fundam Clin Pharmacol , vol.22 , Issue.2 , pp. 127-140
    • Bate, A.1    Lindquist, M.2    Edwards, I.R.3
  • 192
    • 69849112772 scopus 로고    scopus 로고
    • Pharmacovigilance of biopharmaceuticals: Challenges remain
    • 19722725
    • Giezen TJ, Mantel-Teeuwisse AK, Leufkens HG. Pharmacovigilance of biopharmaceuticals: challenges remain. Drug Saf. 2009;32(10):811-7.
    • (2009) Drug Saf , vol.32 , Issue.10 , pp. 811-817
    • Giezen, T.J.1    Mantel-Teeuwisse, A.K.2    Leufkens, H.G.3
  • 193
    • 80051665573 scopus 로고    scopus 로고
    • FDA-approved drug labeling for the study of drug-induced liver injury
    • 21624500
    • Chen M, Vijay V, Shi Q, et al. FDA-approved drug labeling for the study of drug-induced liver injury. Drug Discov Today. 2011;16(15-16):697-703.
    • (2011) Drug Discov Today , vol.16 , Issue.15-16 , pp. 697-703
    • Chen, M.1    Vijay, V.2    Shi, Q.3
  • 194
    • 59049100725 scopus 로고    scopus 로고
    • Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: An overview of reports, 2003-2007
    • 19009550
    • Johann-Liang R, Wyeth J, Chen M, et al. Pediatric drug surveillance and the Food and Drug Administration's adverse event reporting system: an overview of reports, 2003-2007. Pharmacoepidemiol Drug Saf. 2009;18(1):24-7.
    • (2009) Pharmacoepidemiol Drug Saf , vol.18 , Issue.1 , pp. 24-27
    • Johann-Liang, R.1    Wyeth, J.2    Chen, M.3
  • 195
    • 33846665203 scopus 로고    scopus 로고
    • Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions
    • 17253879
    • Hauben M, Horn S, Reich L. Potential use of data-mining algorithms for the detection of 'surprise' adverse drug reactions. Drug Saf. 2007;30(2):143-55.
    • (2007) Drug Saf , vol.30 , Issue.2 , pp. 143-155
    • Hauben, M.1    Horn, S.2    Reich, L.3
  • 196
    • 70249139508 scopus 로고    scopus 로고
    • Using electronic health information for pharmacovigilance: The promise and the pitfalls
    • Rosati K. Using electronic health information for pharmacovigilance: the promise and the pitfalls. J Health Life Sci Law. 2009;2:173-239.
    • (2009) J Health Life Sci Law , vol.2 , pp. 173-239
    • Rosati, K.1
  • 197
    • 84864005479 scopus 로고    scopus 로고
    • Two centuries of assessing drug risks
    • 1:CAS:528:DC%2BC38XhtFSgurrF 22808954
    • Avorn J. Two centuries of assessing drug risks. N Engl J Med. 2012;367(3):193-7.
    • (2012) N Engl J Med , vol.367 , Issue.3 , pp. 193-197
    • Avorn, J.1
  • 198
    • 34447130462 scopus 로고    scopus 로고
    • Evolving paradigms in pharmacovigilance
    • 18690923
    • Brewster W, Gibbs T, Lacroix K, et al. Evolving paradigms in pharmacovigilance. Curr Drug Saf. 2006;1(2):127-34.
    • (2006) Curr Drug Saf , vol.1 , Issue.2 , pp. 127-134
    • Brewster, W.1    Gibbs, T.2    Lacroix, K.3
  • 199
    • 34447520376 scopus 로고    scopus 로고
    • Novel statistical tools for monitoring the safety of marketed drugs
    • 1:CAS:528:DC%2BD2sXptVyku7c%3D 17538548
    • Almenoff JS, Pattishall EN, Gibbs TG, et al. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther. 2007;82(2):157-66.
    • (2007) Clin Pharmacol Ther , vol.82 , Issue.2 , pp. 157-166
    • Almenoff, J.S.1    Pattishall, E.N.2    Gibbs, T.G.3
  • 200
    • 1242329171 scopus 로고    scopus 로고
    • Application of data mining techniques in pharmacovigilance
    • 14748811
    • Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol. 2004;57(2):127-34.
    • (2004) Br J Clin Pharmacol , vol.57 , Issue.2 , pp. 127-134
    • Wilson, A.M.1    Thabane, L.2    Holbrook, A.3
  • 201
    • 78549253881 scopus 로고    scopus 로고
    • An experimental investigation of masking in the US FDA adverse event reporting system database
    • 21077702
    • Wang HW, Hochberg AM, Pearson RK, et al. An experimental investigation of masking in the US FDA adverse event reporting system database. Drug Saf. 2010;33(12):1117-33.
    • (2010) Drug Saf , vol.33 , Issue.12 , pp. 1117-1133
    • Wang, H.W.1    Hochberg, A.M.2    Pearson, R.K.3
  • 202
    • 4344689776 scopus 로고    scopus 로고
    • Safety related drug-labelling changes: Findings from two data mining algorithms
    • 15350157
    • Hauben M, Reich L. Safety related drug-labelling changes: findings from two data mining algorithms. Drug Saf. 2004;27(10):735-44.
    • (2004) Drug Saf , vol.27 , Issue.10 , pp. 735-744
    • Hauben, M.1    Reich, L.2
  • 203
    • 33646071805 scopus 로고    scopus 로고
    • Spontaneous reporting of hepatotoxicity associated with antiandrogens: Data from the Spanish pharmacovigilance system
    • 1:CAS:528:DC%2BD28XkvFGms7w%3D 16294367
    • Manso G, Thole Z, Salgueiro E, et al. Spontaneous reporting of hepatotoxicity associated with antiandrogens: data from the Spanish pharmacovigilance system. Pharmacoepidemiol Drug Saf. 2006;15(4):253-9.
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , Issue.4 , pp. 253-259
    • Manso, G.1    Thole, Z.2    Salgueiro, E.3
  • 204
    • 34548060926 scopus 로고    scopus 로고
    • Telithromycin use and spontaneous reports of hepatotoxicity
    • 17696582
    • Dore DD, DiBello JR, Lapane KL. Telithromycin use and spontaneous reports of hepatotoxicity. Drug Saf. 2007;30(8):697-703.
    • (2007) Drug Saf , vol.30 , Issue.8 , pp. 697-703
    • Dore, D.D.1    Dibello, J.R.2    Lapane, K.L.3
  • 205
    • 57449117697 scopus 로고    scopus 로고
    • Risk of hepatotoxicity associated with the use of telithromycin: A signal detection using data mining algorithms
    • 1:CAS:528:DC%2BD1MXmtVersA%3D%3D 19033479
    • Chen Y, Guo JJ, Healy DP, et al. Risk of hepatotoxicity associated with the use of telithromycin: a signal detection using data mining algorithms. Ann Pharmacother. 2008;42(12):1791-6.
    • (2008) Ann Pharmacother , vol.42 , Issue.12 , pp. 1791-1796
    • Chen, Y.1    Guo, J.J.2    Healy, D.P.3
  • 206
    • 58949090373 scopus 로고    scopus 로고
    • Telithromycin-associated hepatotoxicity: Clinical spectrum and causality assessment of 42 cases
    • 19085949
    • Brinker AD, Wassel RT, Lyndly J, et al. Telithromycin-associated hepatotoxicity: clinical spectrum and causality assessment of 42 cases. Hepatology. 2009;49(1):250-7.
    • (2009) Hepatology , vol.49 , Issue.1 , pp. 250-257
    • Brinker, A.D.1    Wassel, R.T.2    Lyndly, J.3
  • 207
    • 0033790481 scopus 로고    scopus 로고
    • Liver damage associated with minocycline use in acne: A systematic review of the published literature and pharmacovigilance data
    • 1:CAS:528:DC%2BD3cXnvV2ltLk%3D 11051220
    • Lawrenson RA, Seaman HE, Sundstrom A, et al. Liver damage associated with minocycline use in acne: a systematic review of the published literature and pharmacovigilance data. Drug Saf. 2000;23(4):333-49.
    • (2000) Drug Saf , vol.23 , Issue.4 , pp. 333-349
    • Lawrenson, R.A.1    Seaman, H.E.2    Sundstrom, A.3
  • 208
    • 0035018869 scopus 로고    scopus 로고
    • Pemoline hepatotoxicity and postmarketing surveillance
    • 1:STN:280:DC%2BD3MzhslymtQ%3D%3D 11392339
    • Safer DJ, Zito JM, Gardner JE. Pemoline hepatotoxicity and postmarketing surveillance. J Am Acad Child Adolesc Psychiatry. 2001;40(6):622-9.
    • (2001) J Am Acad Child Adolesc Psychiatry , vol.40 , Issue.6 , pp. 622-629
    • Safer, D.J.1    Zito, J.M.2    Gardner, J.E.3
  • 209
    • 38549157094 scopus 로고    scopus 로고
    • A surveillance method for the early identification of idiosyncratic adverse drug reactions
    • 1:CAS:528:DC%2BD1cXjslWlurc%3D 18217792
    • Etwel FA, Rieder MJ, Bend JR, et al. A surveillance method for the early identification of idiosyncratic adverse drug reactions. Drug Saf. 2008;31(2):169-80.
    • (2008) Drug Saf , vol.31 , Issue.2 , pp. 169-180
    • Etwel, F.A.1    Rieder, M.J.2    Bend, J.R.3
  • 210
    • 33845383157 scopus 로고    scopus 로고
    • Fluvastatin and hepatic reactions: A signal from spontaneous reporting in Italy
    • 1:CAS:528:DC%2BD2sXhtVCms78%3D 17147462
    • Conforti A, Magro L, Moretti U, et al. Fluvastatin and hepatic reactions: a signal from spontaneous reporting in Italy. Drug Saf. 2006;29(12):1163-72.
    • (2006) Drug Saf , vol.29 , Issue.12 , pp. 1163-1172
    • Conforti, A.1    Magro, L.2    Moretti, U.3
  • 211
    • 77950583142 scopus 로고    scopus 로고
    • Clinically significant liver injury in patients treated with natalizumab
    • 1:CAS:528:DC%2BC3cXmtFOgsb8%3D 20163378
    • Bezabeh S, Flowers CM, Kortepeter C, et al. Clinically significant liver injury in patients treated with natalizumab. Aliment Pharmacol Ther. 2010;31(9):1028-35.
    • (2010) Aliment Pharmacol Ther , vol.31 , Issue.9 , pp. 1028-1035
    • Bezabeh, S.1    Flowers, C.M.2    Kortepeter, C.3
  • 212
    • 37349006881 scopus 로고    scopus 로고
    • Postmarketing hepatic adverse event experience with PEGylated/non- PEGylated drugs: A disproportionality analysis
    • 18049161
    • Hauben M, Vegni F, Reich L, et al. Postmarketing hepatic adverse event experience with PEGylated/non-PEGylated drugs: a disproportionality analysis. Eur J Gastroenterol Hepatol. 2007;19(11):934-41.
    • (2007) Eur J Gastroenterol Hepatol , vol.19 , Issue.11 , pp. 934-941
    • Hauben, M.1    Vegni, F.2    Reich, L.3
  • 213
    • 66749083239 scopus 로고    scopus 로고
    • Hepatic effects of duloxetine - III: Analysis of hepatic events using external data sources
    • Stromborn I, Wernicke JF, Seeger J, et al. Hepatic effects of duloxetine - III: analysis of hepatic events using external data sources. Curr Drug Saf. 2008;3(2):154-62.
    • (2008) Curr Drug Saf , vol.3 , Issue.2 , pp. 154-162
    • Stromborn, I.1    Wernicke, J.F.2    Seeger, J.3
  • 214
    • 33846508107 scopus 로고    scopus 로고
    • Safety of lovastatin/extended release niacin compared with lovastatin alone, atorvastatin alone, pravastatin alone, and simvastatin alone (from the United States Food and Drug Administration adverse event reporting system)
    • 1:CAS:528:DC%2BD2sXhtVKgtb8%3D 17261402
    • Alsheikh-Ali AA, Karas RH. Safety of lovastatin/extended release niacin compared with lovastatin alone, atorvastatin alone, pravastatin alone, and simvastatin alone (from the United States Food and Drug Administration adverse event reporting system). Am J Cardiol. 2007;99(3):379-81.
    • (2007) Am J Cardiol , vol.99 , Issue.3 , pp. 379-381
    • Alsheikh-Ali, A.A.1    Karas, R.H.2
  • 215
    • 23644450583 scopus 로고    scopus 로고
    • Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001)
    • 16048358
    • Thiessard F, Roux E, Miremont-Salame G, et al. Trends in spontaneous adverse drug reaction reports to the French pharmacovigilance system (1986-2001). Drug Saf. 2005;28(8):731-40.
    • (2005) Drug Saf , vol.28 , Issue.8 , pp. 731-740
    • Thiessard, F.1    Roux, E.2    Miremont-Salame, G.3
  • 216
    • 34548602369 scopus 로고    scopus 로고
    • Serious adverse drug events reported to the Food and Drug Administration, 1998-2005
    • 17846394
    • Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998-2005. Arch Intern Med. 2007;167(16):1752-9.
    • (2007) Arch Intern Med , vol.167 , Issue.16 , pp. 1752-1759
    • Moore, T.J.1    Cohen, M.R.2    Furberg, C.D.3
  • 217
    • 58149394706 scopus 로고    scopus 로고
    • Determinants of under-reporting of adverse drug reactions: A systematic review
    • 1:CAS:528:DC%2BD1MXjslaltLY%3D 19132802
    • Lopez-Gonzalez E, Herdeiro MT, Figueiras A. Determinants of under-reporting of adverse drug reactions: a systematic review. Drug Saf. 2009;32(1):19-31.
    • (2009) Drug Saf , vol.32 , Issue.1 , pp. 19-31
    • Lopez-Gonzalez, E.1    Herdeiro, M.T.2    Figueiras, A.3
  • 218
    • 80053254385 scopus 로고    scopus 로고
    • Using information mining of the medical literature to improve drug safety
    • Shetty KD, Dalal SR. Using information mining of the medical literature to improve drug safety. J Am Med Inf Assoc. 2011;18(5):668-74.
    • (2011) J Am Med Inf Assoc. , vol.18 , Issue.5 , pp. 668-674
    • Shetty, K.D.1    Dalal, S.R.2
  • 219
    • 84855344908 scopus 로고    scopus 로고
    • Data sources on drug safety evaluation: A review of recent published meta-analyses
    • 22025370
    • Alves C, Batel-Marques F, Macedo AF. Data sources on drug safety evaluation: a review of recent published meta-analyses. Pharmacoepidemiol Drug Saf. 2012;21(1):21-33.
    • (2012) Pharmacoepidemiol Drug Saf , vol.21 , Issue.1 , pp. 21-33
    • Alves, C.1    Batel-Marques, F.2    MacEdo, A.F.3
  • 220
    • 35448931891 scopus 로고    scopus 로고
    • Searching for a needle in a hatstack: Use of ICD-9-CM codes in drug-induced liver injury
    • 17662100
    • Jinjuvadia K, Kwan W, Fontana RJ. Searching for a needle in a hatstack: use of ICD-9-CM codes in drug-induced liver injury. Am J Gastroenterol. 2007;102(11):2437-43.
    • (2007) Am J Gastroenterol , vol.102 , Issue.11 , pp. 2437-2443
    • Jinjuvadia, K.1    Kwan, W.2    Fontana, R.J.3
  • 221
    • 0036323793 scopus 로고    scopus 로고
    • Incidence of drug-induced hepatic injuries: A French population-based study
    • 12143055
    • Sgro C, Clinard F, Quazir K, et al. Incidence of drug-induced hepatic injuries: a French population-based study. Hepatology. 2002;36(2):451-5.
    • (2002) Hepatology , vol.36 , Issue.2 , pp. 451-455
    • Sgro, C.1    Clinard, F.2    Quazir, K.3
  • 222
    • 38449085273 scopus 로고    scopus 로고
    • Effect of consumer reporting on signal detection: Using disproportionality analysis
    • 17967159
    • Hammond IW, Rich DS, Gibbs TG. Effect of consumer reporting on signal detection: using disproportionality analysis. Expert Opin Drug Saf. 2007;6(6):705-12.
    • (2007) Expert Opin Drug Saf , vol.6 , Issue.6 , pp. 705-712
    • Hammond, I.W.1    Rich, D.S.2    Gibbs, T.G.3
  • 223
    • 71549140399 scopus 로고    scopus 로고
    • Adverse symptom reporting by patients versus clinicians: Relationships with clinical outcomes
    • 19920223
    • Basch E, Jia X, Heller G, et al. Adverse symptom reporting by patients versus clinicians: relationships with clinical outcomes. J Natl Cancer Inst. 2009;101(23):1624-32.
    • (2009) J Natl Cancer Inst , vol.101 , Issue.23 , pp. 1624-1632
    • Basch, E.1    Jia, X.2    Heller, G.3
  • 224
    • 77949407113 scopus 로고    scopus 로고
    • The missing voice of patients in drug-safety reporting
    • 1:CAS:528:DC%2BC3cXjt1yls7o%3D 20220181
    • Basch E. The missing voice of patients in drug-safety reporting. N Engl J Med. 2010;362(10):865-9.
    • (2010) N Engl J Med , vol.362 , Issue.10 , pp. 865-869
    • Basch, E.1
  • 225
    • 80053917697 scopus 로고    scopus 로고
    • The importance of direct patient reporting of suspected adverse drug reactions: A patient perspective
    • 21496066
    • Anderson C, Krska J, Murphy E, et al. The importance of direct patient reporting of suspected adverse drug reactions: a patient perspective. Br J Clin Pharmacol. 2011;72(5):806-22.
    • (2011) Br J Clin Pharmacol , vol.72 , Issue.5 , pp. 806-822
    • Anderson, C.1    Krska, J.2    Murphy, E.3
  • 226
    • 79960770497 scopus 로고    scopus 로고
    • Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': Literature review, descriptive and qualitative analyses, and questionnaire surveys
    • 1:STN:280:DC%2BC3MvovVChtQ%3D%3D 21545758
    • Avery AJ, Anderson C, Bond CM, et al. Evaluation of patient reporting of adverse drug reactions to the UK 'Yellow Card Scheme': literature review, descriptive and qualitative analyses, and questionnaire surveys. Health Technol Assess. 2011;15:1-234.
    • (2011) Health Technol Assess , vol.15 , pp. 1-234
    • Avery, A.J.1    Anderson, C.2    Bond, C.M.3
  • 227
    • 79952202184 scopus 로고    scopus 로고
    • Improving the reporting of adverse drug reactions in the hospital setting
    • 21084792
    • Pushkin R, Frassetto L, Tsourounis C, et al. Improving the reporting of adverse drug reactions in the hospital setting. Postgrad Med. 2010;122(6):154-64.
    • (2010) Postgrad Med , vol.122 , Issue.6 , pp. 154-164
    • Pushkin, R.1    Frassetto, L.2    Tsourounis, C.3
  • 228
    • 79958696382 scopus 로고    scopus 로고
    • Influence of attitudes on pharmacists' intention to report serious adverse drug events to the Food and Drug Administration
    • 21332572
    • Gavaza P, Brown CM, Lawson KA, et al. Influence of attitudes on pharmacists' intention to report serious adverse drug events to the Food and Drug Administration. Br J Clin Pharmacol. 2011;72(1):143-52.
    • (2011) Br J Clin Pharmacol , vol.72 , Issue.1 , pp. 143-152
    • Gavaza, P.1    Brown, C.M.2    Lawson, K.A.3
  • 229
    • 0036710650 scopus 로고    scopus 로고
    • Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions
    • 1:STN:280:DC%2BD38njsFejtw%3D%3D 12393084
    • Hasford J, Goettler M, Munter KH, et al. Physicians' knowledge and attitudes regarding the spontaneous reporting system for adverse drug reactions. J Clin Epidemiol. 2002;55(9):945-50.
    • (2002) J Clin Epidemiol , vol.55 , Issue.9 , pp. 945-950
    • Hasford, J.1    Goettler, M.2    Munter, K.H.3
  • 230
    • 0027980328 scopus 로고
    • Physicians' liability for adverse drug reactions
    • 1:STN:280:DyaK2czivFygug%3D%3D 8052883
    • Kaufman MB, Stoukides CA, Campbell NA. Physicians' liability for adverse drug reactions. South Med J. 1994;87(8):780-4.
    • (1994) South Med J , vol.87 , Issue.8 , pp. 780-784
    • Kaufman, M.B.1    Stoukides, C.A.2    Campbell, N.A.3
  • 231
    • 33846413998 scopus 로고    scopus 로고
    • The role of litigation in defining drug risks
    • 1:CAS:528:DC%2BD2sXnvVeqtQ%3D%3D 17227983
    • Kesselheim AS, Avorn J. The role of litigation in defining drug risks. JAMA. 2007;297(3):308-11.
    • (2007) JAMA , vol.297 , Issue.3 , pp. 308-311
    • Kesselheim, A.S.1    Avorn, J.2
  • 232
    • 84859699141 scopus 로고    scopus 로고
    • Mechanistic biomarkers in acute liver injury: Are we there yet?
    • 22322232
    • Adebayo D, Mookerjee RP, Jalan R. Mechanistic biomarkers in acute liver injury: are we there yet? J Hepatol. 2012;56(5):1003-5.
    • (2012) J Hepatol , vol.56 , Issue.5 , pp. 1003-1005
    • Adebayo, D.1    Mookerjee, R.P.2    Jalan, R.3
  • 233
    • 70449109529 scopus 로고    scopus 로고
    • Biomarkers for the diagnosis and management of drug-induced liver injury
    • 1:CAS:528:DC%2BD1MXhtl2ksL3E 19826973
    • Watkins PB. Biomarkers for the diagnosis and management of drug-induced liver injury. Semin Liver Dis. 2009;29(4):393-9.
    • (2009) Semin Liver Dis , vol.29 , Issue.4 , pp. 393-399
    • Watkins, P.B.1
  • 234
    • 84864810275 scopus 로고    scopus 로고
    • Development of a pharmaceutical hepatotoxicity biomarker panel using a discovery to targeted proteomics approach
    • 22527513
    • Collins BC, Miller CA, Sposny A, et al. Development of a pharmaceutical hepatotoxicity biomarker panel using a discovery to targeted proteomics approach. Mol Cell Proteomics. 2012;11(8):394-410.
    • (2012) Mol Cell Proteomics , vol.11 , Issue.8 , pp. 394-410
    • Collins, B.C.1    Miller, C.A.2    Sposny, A.3
  • 235
    • 39649094514 scopus 로고    scopus 로고
    • The current state of serum biomarkers of hepatotoxicity
    • 1:CAS:528:DC%2BD1cXislSltrY%3D 18291570
    • Ozer J, Ratner M, Shaw M, et al. The current state of serum biomarkers of hepatotoxicity. Toxicology. 2008;245(3):194-205.
    • (2008) Toxicology , vol.245 , Issue.3 , pp. 194-205
    • Ozer, J.1    Ratner, M.2    Shaw, M.3
  • 236
    • 77953798674 scopus 로고    scopus 로고
    • Recommendations to qualify biomarker candidates of drug-induced liver injury
    • 1:CAS:528:DC%2BC3cXnsFSru7c%3D 20550481
    • Ozer JS, Chetty R, Kenna G, et al. Recommendations to qualify biomarker candidates of drug-induced liver injury. Biomark Med. 2010;4(3):475-83.
    • (2010) Biomark Med , vol.4 , Issue.3 , pp. 475-483
    • Ozer, J.S.1    Chetty, R.2    Kenna, G.3
  • 237
    • 84862777266 scopus 로고    scopus 로고
    • Serum proteomic profiling in patients with drug-induced liver injury
    • 1:CAS:528:DC%2BC38XksFams7Y%3D 22403816
    • Bell LN, Vuppalanchi R, Watkins PB, et al. Serum proteomic profiling in patients with drug-induced liver injury. Aliment Pharmacol Ther. 2012;35(5):600-12.
    • (2012) Aliment Pharmacol Ther , vol.35 , Issue.5 , pp. 600-612
    • Bell, L.N.1    Vuppalanchi, R.2    Watkins, P.B.3
  • 238
    • 84878618951 scopus 로고    scopus 로고
    • Abacavir. (Accessed 22 March 2013)
    • Abacavir. LiverTox Drug record. http://livertox.nih.gov/Abacavir.htm (Accessed 22 March 2013).
    • LiverTox Drug Record
  • 239
    • 3042634326 scopus 로고    scopus 로고
    • Cost-effectiveness analysis of HLA B*5701 genotyping in preventing abacavir hypersensitivity
    • 15247625
    • Hughes DA, Vilar FJ, Ward CC, et al. Cost-effectiveness analysis of HLA B*5701 genotyping in preventing abacavir hypersensitivity. Pharmacogenetics. 2004;14(6):335-42.
    • (2004) Pharmacogenetics , vol.14 , Issue.6 , pp. 335-342
    • Hughes, D.A.1    Vilar, F.J.2    Ward, C.C.3
  • 240
    • 38949196447 scopus 로고    scopus 로고
    • HLA-B*5701 screening for hypersensitivity to abacavir
    • 18256392
    • Mallal S, Phillips E, Carosi G, et al. HLA-B*5701 screening for hypersensitivity to abacavir. N Engl J Med. 2008;358(6):568-79.
    • (2008) N Engl J Med , vol.358 , Issue.6 , pp. 568-579
    • Mallal, S.1    Phillips, E.2    Carosi, G.3
  • 241
    • 79957523368 scopus 로고    scopus 로고
    • Susceptibility to amoxicillin-clavulanate-induced liver injury is influenced by multiple HLA class i and II alleles
    • 1:CAS:528:DC%2BC3MXosVGnsLg%3D 21570397
    • Lucena M, Molokhia M, Shen Y. Susceptibility to amoxicillin-clavulanate- induced liver injury is influenced by multiple HLA class I and II alleles. Gastroenterology. 2011;141(1):338-47.
    • (2011) Gastroenterology , vol.141 , Issue.1 , pp. 338-347
    • Lucena, M.1    Molokhia, M.2    Shen, Y.3
  • 242
    • 78649903976 scopus 로고    scopus 로고
    • Genome-wide association studies and genetic risk assessment of liver diseases
    • 21045792
    • Krawczyk M, Mullenbach R, Weber S, et al. Genome-wide association studies and genetic risk assessment of liver diseases. Nat Rev Gastroenterol Hepatol. 2010;7:669-80.
    • (2010) Nat Rev Gastroenterol Hepatol , vol.7 , pp. 669-680
    • Krawczyk, M.1    Mullenbach, R.2    Weber, S.3
  • 243
    • 77955780844 scopus 로고    scopus 로고
    • Predicting and preventing acute drug-induced liver injury: What's new in 2010
    • Liss G, Rattan S, Lewis JH. Predicting and preventing acute drug-induced liver injury: what's new in 2010. Expert Opin Drug Metab Toxicol. 2010;6(9):1-15.
    • (2010) Expert Opin Drug Metab Toxicol , vol.6 , Issue.9 , pp. 1-15
    • Liss, G.1    Rattan, S.2    Lewis, J.H.3
  • 244
    • 79959213923 scopus 로고    scopus 로고
    • Drug-induced liver injury: A summary of recent advances
    • 21510822
    • Stine JG, Lewis JH. Drug-induced liver injury: a summary of recent advances. Expert Opin Drug metab Toxicol. 2011;7(7):875-90.
    • (2011) Expert Opin Drug Metab Toxicol , vol.7 , Issue.7 , pp. 875-890
    • Stine, J.G.1    Lewis, J.H.2
  • 245
    • 79956333428 scopus 로고    scopus 로고
    • The phenotype standardization project: Improving pharmacogenetic studies of serious adverse drug reactions
    • 1:STN:280:DC%2BC3MrjtlWqsQ%3D%3D 21593754
    • Pirmohamed M, Aithal GP, Behr E, et al. The phenotype standardization project: improving pharmacogenetic studies of serious adverse drug reactions. Clin Pharmacol Ther. 2011;89(6):784-8.
    • (2011) Clin Pharmacol Ther , vol.89 , Issue.6 , pp. 784-788
    • Pirmohamed, M.1    Aithal, G.P.2    Behr, E.3
  • 246
    • 1542316128 scopus 로고    scopus 로고
    • Data safety monitoring boards
    • 1:CAS:528:DC%2BD2cXitV2qu78%3D 15014189
    • Slutsky AS, Lavery JV. Data safety monitoring boards. N Engl J Med. 2004;350(11):1143-6.
    • (2004) N Engl J Med , vol.350 , Issue.11 , pp. 1143-1146
    • Slutsky, A.S.1    Lavery, J.V.2
  • 247
    • 84939548791 scopus 로고    scopus 로고
    • An opinion and practice survey on the structure and management of data and safety monitoring boards
    • Tereskerz PM, Guterbock TM, Kermer DA, et al. An opinion and practice survey on the structure and management of data and safety monitoring boards. Acc Res. 2011;18(1):1-30.
    • (2011) Acc Res , vol.18 , Issue.1 , pp. 1-30
    • Tereskerz, P.M.1    Guterbock, T.M.2    Kermer, D.A.3
  • 248
    • 0027443470 scopus 로고
    • Risk-benefit assessment of new drugs: Perspectives of a former FDA Advisory Committee member
    • Lewis JH. Risk-benefit assessment of new drugs: perspectives of a former FDA Advisory Committee member. Drug Inf J. 1993;27:1037-49.
    • (1993) Drug Inf J , vol.27 , pp. 1037-1049
    • Lewis, J.H.1
  • 249
    • 84855823712 scopus 로고    scopus 로고
    • Risk evaluation and mitigation strategies (REMS): Educating the prescriber
    • 1:CAS:528:DC%2BC38XnsVKjt7g%3D 22171604
    • Nicholson SC, Peterson J, Yektashenas B. Risk evaluation and mitigation strategies (REMS): educating the prescriber. Drug Saf. 2012;35(1):91-104.
    • (2012) Drug Saf , vol.35 , Issue.1 , pp. 91-104
    • Nicholson, S.C.1    Peterson, J.2    Yektashenas, B.3


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