메뉴 건너뛰기




Volumn 23, Issue 3, 2009, Pages 149-158

Evidence-based liver chemistry monitoring in drug development

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; BENOXAPROFEN; BILIRUBIN; BROMFENAC; TIENILIC ACID; TROGLITAZONE; TROVAFLOXACIN;

EID: 69249093416     PISSN: 11782595     EISSN: 11791993     Source Type: Journal    
DOI: 10.1007/bf03256763     Document Type: Article
Times cited : (4)

References (47)
  • 1
    • 0041342015 scopus 로고    scopus 로고
    • Drug-induced hepatotoxicity
    • Lee WM. Drug-induced hepatotoxicity. N Engl J Med 2003; 349 (5): 474-485
    • (2003) N Engl J Med , vol.349 , Issue.5 , pp. 474-485
    • Lee, W.M.1
  • 2
    • 0037126649 scopus 로고    scopus 로고
    • Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States
    • Acute Liver Failure Study Group
    • Ostapowicz G, Fontana RJ, Schiodt FV, et al., Acute Liver Failure Study Group. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. Ann Intern Med 2002; 137: 947-954
    • (2002) Ann Intern Med , vol.137 , pp. 947-954
    • Ostapowicz, G.1    Fontana, R.J.2    Schiodt, F.V.3
  • 3
    • 0029129057 scopus 로고
    • Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 to 1983: A regulatory perspective
    • Bakke OM, Mannochia M, de Abajo F, et al. Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 to 1983: a regulatory perspective. Clin Pharmacol Ther 1995; 58: 108-117
    • (1995) Clin Pharmacol Ther , vol.58 , pp. 108-117
    • Bakke, O.M.1    Mannochia, M.2    De Abajo, F.3
  • 4
    • 22144474788 scopus 로고    scopus 로고
    • Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002
    • Wysowski DK, Swartz L. Adverse drug event surveillance and drug withdrawals in the United States, 1969-2002. Arch Intern Med 2005; 165: 1363-1369
    • (2005) Arch Intern Med , vol.165 , pp. 1363-1369
    • Wysowski, D.K.1    Swartz, L.2
  • 5
    • 85184383540 scopus 로고    scopus 로고
    • Available from URL: [Accessed 2008 Oct 17]
    • U.S. Food and Drug Administration Center for Drug Evaluation and Research. Drug-induced liver toxicity [online]. Available from URL: http:// www.fda.gov/cder/livertox/default.htm [Accessed 2008 Oct 17]
    • Drug-induced Liver Toxicity [Online]
  • 6
    • 85184379033 scopus 로고    scopus 로고
    • Available from URL: [Accessed 2008 Oct 17]
    • U.S. Food and Drug Administration. World Health Organization graded laboratory tables [online]. Available from URL: http://www.fda.gov/cder/ cancer/toxicityframe.htm [Accessed 2008 Oct 17]
    • World Health Organization Graded Laboratory Tables [Online]
  • 7
    • 33646024613 scopus 로고    scopus 로고
    • Hy's law: Predicting serious hepatotoxicity
    • Temple R. Hy's law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf 2006; 15: 241-243
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , pp. 241-243
    • Temple, R.1
  • 8
    • 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
    • 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: 1323-1330
    • (1993) J Clin Epidemiol , vol.46 , pp. 1323-1330
    • Danan, G.1    Benichou, C.2
  • 9
    • 33646052267 scopus 로고    scopus 로고
    • Rules and laws of drug hepatotoxicity
    • Kaplowitz N. Rules and laws of drug hepatotoxicity. Pharmacoepidemiol Drug Saf 2006; 15: 231-233
    • (2006) Pharmacoepidemiol Drug Saf , vol.15 , pp. 231-233
    • Kaplowitz, N.1
  • 10
    • 0032701360 scopus 로고    scopus 로고
    • Acute Liver failure associated with prolonged use of bromfenac leading to liver transplantation
    • Fontana RJ, Timothy M, McCashland TM, et al. Acute Liver failure associated with prolonged use of bromfenac leading to liver transplantation. Liver Transpl Surg 1999; 5: 480-484
    • (1999) Liver Transpl Surg , vol.5 , pp. 480-484
    • Fontana, R.J.1    Timothy, M.2    McCashland, T.M.3
  • 11
    • 0004039221 scopus 로고    scopus 로고
    • Philadelphia (PA): Lippincott Williams & Wilkins
    • Zimmerman HJ. Hepatotoxicity. 2nd ed. Philadelphia (PA): Lippincott Williams & Wilkins, 1999
    • (1999) Hepatotoxicity. 2nd Ed
    • Zimmerman, H.J.1
  • 12
    • 0019945559 scopus 로고
    • Hepatotoxicity associated with ticrynafen: A uricosuric diuretic
    • Manier JW, Chang WW, Kirschner JP, et al. Hepatotoxicity associated with ticrynafen: a uricosuric diuretic. Am J Gastroenterol 1982; 77 (6): 401-404
    • (1982) Am J Gastroenterol , vol.77 , Issue.6 , pp. 401-404
    • Manier, J.W.1    Chang, W.W.2    Kirschner, J.P.3
  • 13
    • 0021234189 scopus 로고
    • Ticrynafen-associated hepatic injury: Analysis of 340 cases
    • Zimmerman HJ, Lewis JH, Ishak KG, et al. Ticrynafen-associated hepatic injury: analysis of 340 cases. Hepatology 1984; 4 (2) 315-323 (Pubitemid 14131442)
    • (1984) Hepatology , vol.4 , Issue.2 , pp. 315-323
    • Zimmerman, H.J.1    Lewis, J.H.2    Ishak, K.G.3    Maddrey, W.C.4
  • 14
    • 0036695061 scopus 로고    scopus 로고
    • Immune-mediated drug-induced liver disease
    • Liu ZX, Kaplowitz N. Immune-mediated drug-induced liver disease. Clin Liver Dis 2002; 6: 755-774
    • (2002) Clin Liver Dis , vol.6 , pp. 755-774
    • Liu, Z.X.1    Kaplowitz, N.2
  • 16
    • 0035169430 scopus 로고    scopus 로고
    • Hepatotoxicity with thiazolidinediones: Is it a class effect
    • Scheen AJ. Hepatotoxicity with thiazolidinediones: is it a class effect. Drug Saf 2001; 24 (12): 873-888
    • (2001) Drug Saf , vol.24 , Issue.12 , pp. 873-888
    • Scheen, A.J.1
  • 17
    • 0000188827 scopus 로고    scopus 로고
    • Liver dysfunction associated with troglitazone (Noscal)
    • [in Japanese]
    • Kuramoto K, Shimizu N, Toda G. Liver dysfunction associated with troglitazone (Noscal) [in Japanese]. Rinsho Iyaku 1998; 14: 461-466
    • (1998) Rinsho Iyaku , vol.14 , pp. 461-466
    • Kuramoto, K.1    Shimizu, N.2    Toda, G.3
  • 18
    • 26444469521 scopus 로고    scopus 로고
    • Rating the severity of the medical consequences of drug-induced liver injury
    • DOI 10.1016/j.yrtph.2005.07.002, PII S0273230005001388
    • Slavin DE, Schlinchting CL, Freston JW. Rating the severity of the medical consequences of drug-induced injury. Regul Toxicol Pharmacol 2005; 43: 134-140 (Pubitemid 41427806)
    • (2005) Regulatory Toxicology and Pharmacology , vol.43 , Issue.2 , pp. 134-140
    • Slavin, D.E.1    Schlichting, C.L.2    Freston, J.W.3
  • 19
    • 0020067465 scopus 로고
    • Benoxaprofen
    • editorial
    • Benoxaprofen [editorial]. BMJ (Clin Res Ed) 1982; 285 (6340): 459-460
    • (1982) BMJ (Clin Res Ed) , vol.285 , Issue.6340 , pp. 459-460
  • 20
    • 0025104012 scopus 로고
    • The importance of pharmacokinetic and receptor studies in drug safety evaluation
    • DOI 10.1016/0273-2300(90)90028-A
    • Eason CT, Bonner FW, Parke DV. The importance of pharmacokinetic and receptor studies in drug safety evaluation. Regul Tox Pharm 1990; 11: 288-307 (Pubitemid 20325470)
    • (1990) Regulatory Toxicology and Pharmacology , vol.11 , Issue.3 , pp. 288-307
    • Eason, C.T.1    Bonner, F.W.2    Parke, D.V.3
  • 21
    • 0023254773 scopus 로고
    • Benoxaprofen case makes legal history
    • Dyer C. Benoxaprofen case makes legal history. BMJ 1987; 295: 39-40 (Pubitemid 17089999)
    • (1987) British Medical Journal , vol.295 , Issue.6589 , pp. 39-40
    • Dyer, C.1
  • 22
    • 0022917633 scopus 로고
    • Effects of non-narcotic analgesics on the liver
    • Prescott LF. Effects of non-narcotic analgesics on the liver. Drugs 1987; 32 Suppl. 4: 129-147
    • (1987) Drugs , Issue.32 SUPPL. 4 , pp. 129-147
    • Prescott, L.F.1
  • 24
    • 0035345666 scopus 로고    scopus 로고
    • Serious liver injury: Leading reason for drug removals, restrictions
    • Meadows M. Serious liver injury: leading reason for drug removals, restrictions. FDA Consum 2001 May-Jun; 35 (3): 8-9 (Pubitemid 33707731)
    • (2001) FDA Consumer , vol.35 , Issue.3 , pp. 8
    • Meadows, M.1
  • 25
    • 85184364977 scopus 로고    scopus 로고
    • Available from URL: [Accessed 24 Jan 2009]
    • U.S. Food and Drug Administration. Trovafloxacin FDA medical review [online]. Available from URL: http://www.fda.gov/cder/foi/nda/97/020760a- medr-P7.pdf [Accessed 24 Jan 2009]
    • Trovafloxacin FDA Medical Review [Online]
  • 26
    • 0035867075 scopus 로고    scopus 로고
    • Antimicrobial safety and tolerability: Differences and dilemmas
    • DOI 10.1086/319379
    • Mandell LA, Ball P, Tillotson G. Antimicrobial safety and tolerability: differences and dilemmas. Clin Infect Dis 2001; 32 Suppl. 1: S72-9 (Pubitemid 32506749)
    • (2001) Clinical Infectious Diseases , vol.32 , Issue.SUPPL. 1
    • Mandell, L.A.1    Ball, P.2    Tillotson, G.3
  • 28
    • 23044473682 scopus 로고    scopus 로고
    • Outcome and prognostic markers in severe drug-induced liver disease
    • DOI 10.1002/hep.20800
    • Bjornsson E, Olsson R. Outcome and prognostic markers in severe druginduced liver disease. Hepatology 2005; 42 (2): 481-489 (Pubitemid 41061102)
    • (2005) Hepatology , vol.42 , Issue.2 , pp. 481-489
    • Bjornsson, E.1    Olsson, R.2
  • 29
    • 18744376412 scopus 로고    scopus 로고
    • Drug-induced liver injury: An analysis of 461 incidences submitted to the Spanish registry over a 10-year period
    • Andrade RJ, Lucena MI, Fernández 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: 512-521
    • (2005) Gastroenterology , vol.129 , pp. 512-521
    • Andrade, R.J.1    Lucena, M.I.2    Fernández, M.C.3
  • 30
    • 0033658160 scopus 로고    scopus 로고
    • Spontaneous reporting of drug-related hepatic reactions from two Italian regions (Lombardy and Veneto)
    • Conforti A, Leone R, Ghiotto E, et al. Spontaneous reporting of drug-related hepatic reactions from two Italian regions (Lombardy and Veneto). Dig Liver Dis 2000; 32: 716-723
    • (2000) Dig Liver Dis , vol.32 , pp. 716-723
    • Conforti, A.1    Leone, R.2    Ghiotto, E.3
  • 31
    • 1542357578 scopus 로고    scopus 로고
    • Liver toxicity in epidemiological cohorts
    • Becker S. Liver toxicity in epidemiological cohorts. Clin Infect Dis 2004; 38 Suppl. 2: S49-55
    • (2004) Clin Infect Dis , Issue.38 SUPPL. 2
    • Becker, S.1
  • 32
    • 85184363679 scopus 로고    scopus 로고
    • Available from URL: [Accessed 2008 Oct 17]
    • U.S. Food and Drug Administration. FDA guidance on safety testing of drug metabolites [online]. Available from URL: http://www.fda.gov/cder/livertox/ default.htm [Accessed 2008 Oct 17]
    • FDA Guidance on Safety Testing of Drug Metabolites [Online]
  • 33
    • 0029093401 scopus 로고
    • Anti-tuberculosis medication and the liver: Dangers and recommendations in management
    • Thompson NP, Caplin ME, Hamilton SH, et al. Anti-tuberculosis medication and the liver: dangers and recommendations in management. Eur Respir J 1995; 8: 1384-1388
    • (1995) Eur Respir J , vol.8 , pp. 1384-1388
    • Thompson, N.P.1    Caplin, M.E.2    Hamilton, S.H.3
  • 34
    • 33645220583 scopus 로고    scopus 로고
    • Drug-induced liver injury: Summary of a single topic clinical research conference
    • Watkins PB, Seeff LB. Drug-induced liver injury: summary of a single topic clinical research conference. Hepatology 2006; 43: 618-631
    • (2006) Hepatology , vol.43 , pp. 618-631
    • Watkins, P.B.1    Seeff, L.B.2
  • 39
    • 34047154993 scopus 로고    scopus 로고
    • Strategies to reduce late-stage drug attrition due to mitochondrial toxicity
    • DOI 10.1586/14737159.7.2.161
    • Dyken JA, Marroquin LD, Will Y. Strategies to reduce late-stage attrition due to mitochondrial toxicity. Exp Rev Mol Diagn 2007; 7 (2): 161-175 (Pubitemid 46513443)
    • (2007) Expert Review of Molecular Diagnostics , vol.7 , Issue.2 , pp. 161-175
    • Dykens, J.A.1    Marroquin, L.D.2    Will, Y.3
  • 40
    • 7444268462 scopus 로고    scopus 로고
    • Adverse hepatic drug reactions: Inflammatory episodes as consequence and contributor
    • Ganey PE, Luyendyk JP, Maddox JF, et al. Adverse hepatic drug reactions: inflammatory episodes as consequence and contributor. Chem Biol Interact 2004; 150: 35-51
    • (2004) Chem Biol Interact , vol.150 , pp. 35-51
    • Ganey, P.E.1    Luyendyk, J.P.2    Maddox, J.F.3
  • 41
    • 85184371118 scopus 로고    scopus 로고
    • [ClinicalTrials.gov identifier no. NCT00360646]. US National Institutes of Health,ClinicalTrials.gov [online]. Available fromURL: [Accessed 2008 Oct 17]
    • ClinicalTrials.gov. Drug-induced liver injury (DILN) network retrospective (ILIAD) [ClinicalTrials.gov identifier no. NCT00360646]. US National Institutes of Health,ClinicalTrials.gov [online]. Available fromURL: http://clinical trials.gov/ [Accessed 2008 Oct 17]
    • Drug-induced Liver Injury (DILN) Network Retrospective (ILIAD)
  • 42
    • 85184383426 scopus 로고    scopus 로고
    • [ClinicalTrials.gov identifier no. NCT00518440]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: [Accessed 2008 Oct 17]
    • ClinicalTrials.gov. A multi-center trial to study acute liver failure in adults (ALFSG) [ClinicalTrials.gov identifier no. NCT00518440]. US National Institutes of Health, ClinicalTrials.gov [online]. Available from URL: http:// clinicaltrials.gov/ [Accessed 2008 Oct 17]
    • A Multi-center Trial to Study Acute Liver Failure in Adults (ALFSG)
  • 43
    • 85184365942 scopus 로고    scopus 로고
    • [online]. Available from URL: [Accessed 2008 Oct 17]
    • International SAE Consortium homepage [online]. Available from URL: http://www.saeconsortium.org/index.php [Accessed 2008 Oct 17]
  • 44
    • 20844444779 scopus 로고    scopus 로고
    • Idiosyncratic drug hepatotoxicity
    • Kaplowitz N. Idiosyncratic drug hepatotoxicity. Nat Rev Drug Discov 2005; 4: 489-499
    • (2005) Nat Rev Drug Discov , vol.4 , pp. 489-499
    • Kaplowitz, N.1
  • 45
    • 19544375388 scopus 로고    scopus 로고
    • Evaluation of cases of severe statinrelated transaminitis within a large health maintenance organization
    • Charles EC, Olson KL, Sandhoff BG. Evaluation of cases of severe statinrelated transaminitis within a large health maintenance organization. Am J Med 2005; 118: 618-624
    • (2005) Am J Med , vol.118 , pp. 618-624
    • Charles, E.C.1    Olson, K.L.2    Sandhoff, B.G.3
  • 46
    • 0033045249 scopus 로고    scopus 로고
    • The natural history of histologically proved drug induced liver disease
    • Aithal PG, Day CP. The natural history of histologically proved drug induced liver disease. Gut 1999; 44: 731-735
    • (1999) Gut , vol.44 , pp. 731-735
    • Aithal, P.G.1    Day, C.P.2
  • 47
    • 55949091969 scopus 로고    scopus 로고
    • Background incidence of liver chemistry abnormalities in a clinical trial population without underlying liver disease
    • Weil JG, Bains C, Linke A, et al. Background incidence of liver chemistry abnormalities in a clinical trial population without underlying liver disease. Regul Toxicol Pharmacol 2008; 52: 85-88
    • (2008) Regul Toxicol Pharmacol , vol.52 , pp. 85-88
    • Weil, J.G.1    Bains, C.2    Linke, A.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.