-
1
-
-
84901766171
-
Clinical features, diagnosis, and natural history of drug-induced liver injury
-
Hayashi PH, Fontana RJ,. Clinical features, diagnosis, and natural history of drug-induced liver injury. Semin Liver Dis 2014; 34: 134-44.
-
(2014)
Semin Liver Dis
, vol.34
, pp. 134-144
-
-
Hayashi, P.H.1
Fontana, R.J.2
-
2
-
-
84878528772
-
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
-
Lewis JH,. 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. Pharmaceut Med 2013; 27: 165-91.
-
(2013)
Pharmaceut Med
, vol.27
, pp. 165-191
-
-
Lewis, J.H.1
-
3
-
-
84876575913
-
Postmarketing safety surveillance: Where does signal detection using electronic healthcare records fit into the big picture?
-
Coloma PM, Trifiro G, Patadia V, Sturkenboom M,. Postmarketing safety surveillance: where does signal detection using electronic healthcare records fit into the big picture? Drug Saf 2013; 36: 183-97.
-
(2013)
Drug Saf
, vol.36
, pp. 183-197
-
-
Coloma, P.M.1
Trifiro, G.2
Patadia, V.3
Sturkenboom, M.4
-
4
-
-
84878260825
-
Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system
-
Harpaz R, DuMouchel W, LePendu P, Bauer-Mehren A, Ryan P, Shah NH,. Performance of pharmacovigilance signal-detection algorithms for the FDA adverse event reporting system. Clin Pharmacol Ther 2013; 93: 539-46.
-
(2013)
Clin Pharmacol Ther
, vol.93
, pp. 539-546
-
-
Harpaz, R.1
Dumouchel, W.2
Lependu, P.3
Bauer-Mehren, A.4
Ryan, P.5
Shah, N.H.6
-
5
-
-
84890419899
-
Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA adverse event reporting system (FAERS) database
-
Brinker AD, Lyndly J, Tonning J, Moeny D, Levine JG, Avigan MI,. Profiling cumulative proportional reporting ratios of drug-induced liver injury in the FDA adverse event reporting system (FAERS) database. Drug Saf 2013; 36: 1169-78.
-
(2013)
Drug Saf
, vol.36
, pp. 1169-1178
-
-
Brinker, A.D.1
Lyndly, J.2
Tonning, J.3
Moeny, D.4
Levine, J.G.5
Avigan, M.I.6
-
6
-
-
84882909945
-
Novel oral anticoagulants: Clinical pharmacology, indications and practical considerations
-
Harder S, Graff J,. Novel oral anticoagulants: clinical pharmacology, indications and practical considerations. Eur J Clin Pharmacol 2013; 69: 1617-33.
-
(2013)
Eur J Clin Pharmacol
, vol.69
, pp. 1617-1633
-
-
Harder, S.1
Graff, J.2
-
7
-
-
34548031359
-
The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects
-
Stangier J, Rathgen K, Stahle H, Gansser D, Roth W,. The pharmacokinetics, pharmacodynamics and tolerability of dabigatran etexilate, a new oral direct thrombin inhibitor, in healthy male subjects. Br J Clin Pharmacol 2007; 64: 292-303.
-
(2007)
Br J Clin Pharmacol
, vol.64
, pp. 292-303
-
-
Stangier, J.1
Rathgen, K.2
Stahle, H.3
Gansser, D.4
Roth, W.5
-
8
-
-
78649289929
-
Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor
-
Kubitza D, Becka M, Mueck W, Halabi A, Maatouk H, Klause N, Lufft V, Wand DD, Philipp T, Bruck H,. Effects of renal impairment on the pharmacokinetics, pharmacodynamics and safety of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol 2010; 70: 703-12.
-
(2010)
Br J Clin Pharmacol
, vol.70
, pp. 703-712
-
-
Kubitza, D.1
Becka, M.2
Mueck, W.3
Halabi, A.4
Maatouk, H.5
Klause, N.6
Lufft, V.7
Wand, D.D.8
Philipp, T.9
Bruck, H.10
-
9
-
-
84879486549
-
Effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of a single dose of rivaroxaban, an oral, direct Factor Xa inhibitor
-
Kubitza D, Roth A, Becka M, Alatrach A, Halabi A, Hinrichsen H, Mueck W,. Effect of hepatic impairment on the pharmacokinetics and pharmacodynamics of a single dose of rivaroxaban, an oral, direct Factor Xa inhibitor. Br J Clin Pharmacol 2013; 76: 89-98.
-
(2013)
Br J Clin Pharmacol
, vol.76
, pp. 89-98
-
-
Kubitza, D.1
Roth, A.2
Becka, M.3
Alatrach, A.4
Halabi, A.5
Hinrichsen, H.6
Mueck, W.7
-
10
-
-
84872260247
-
Apixaban, an oral, direct factor Xa inhibitor: Single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects
-
Frost C, Wang J, Nepal S, Schuster A, Barrett YC, Mosqueda-Garcia R, Reeves RA, LaCreta F,. Apixaban, an oral, direct factor Xa inhibitor: single dose safety, pharmacokinetics, pharmacodynamics and food effect in healthy subjects. Br J Clin Pharmacol 2013; 75: 476-87.
-
(2013)
Br J Clin Pharmacol
, vol.75
, pp. 476-487
-
-
Frost, C.1
Wang, J.2
Nepal, S.3
Schuster, A.4
Barrett, Y.C.5
Mosqueda-Garcia, R.6
Reeves, R.A.7
Lacreta, F.8
-
11
-
-
84878952383
-
Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects
-
Frost C, Nepal S, Wang J, Schuster A, Byon W, Boyd RA, Yu Z, Shenker A, Barrett YC, Mosqueda-Garcia R, Lacreta F,. Safety, pharmacokinetics and pharmacodynamics of multiple oral doses of apixaban, a factor Xa inhibitor, in healthy subjects. Br J Clin Pharmacol 2013; 76: 776-86.
-
(2013)
Br J Clin Pharmacol
, vol.76
, pp. 776-786
-
-
Frost, C.1
Nepal, S.2
Wang, J.3
Schuster, A.4
Byon, W.5
Boyd, R.A.6
Yu, Z.7
Shenker, A.8
Barrett, Y.C.9
Mosqueda-Garcia, R.10
Lacreta, F.11
-
12
-
-
84896544335
-
Risk of drug-induced liver injury with the new oral anticoagulants: Systematic review and meta-analysis
-
Caldeira D, Barra M, Santos AT, de Abreu D, Pinto FJ, Ferreira JJ, Costa J,. Risk of drug-induced liver injury with the new oral anticoagulants: systematic review and meta-analysis. Heart 2014; 100: 550-6.
-
(2014)
Heart
, vol.100
, pp. 550-556
-
-
Caldeira, D.1
Barra, M.2
Santos, A.T.3
De Abreu, D.4
Pinto, F.J.5
Ferreira, J.J.6
Costa, J.7
-
13
-
-
77949312944
-
Drug-induced liver injury in humans: The case of ximelagatran
-
Keisu M, Andersson TB,. Drug-induced liver injury in humans: the case of ximelagatran. Handb Exp Pharmacol 2010; 196: 407-18.
-
(2010)
Handb Exp Pharmacol
, vol.196
, pp. 407-418
-
-
Keisu, M.1
Andersson, T.B.2
-
15
-
-
0028018092
-
Mayer zum Buschenfelde KH. Drug-induced hepatitis: A rare complication of oral anticoagulants
-
Hohler T, Schnutgen M, Helmreich-Becker I, Mayet WJ, Mayer zum Buschenfelde KH. Drug-induced hepatitis: a rare complication of oral anticoagulants. J Hepatol 1994; 21: 447-9.
-
(1994)
J Hepatol
, vol.21
, pp. 447-449
-
-
Hohler, T.1
Schnutgen, M.2
Helmreich-Becker, I.3
Mayet, W.J.4
-
16
-
-
3442901630
-
Phenprocoumon-induced liver disease ranges from mild acute hepatitis to (sub-) acute liver failure
-
Schimanski CC, Burg J, Mohler M, Höhler T, Kanzler S, Otto G, Galle PR, Lohse AW,. Phenprocoumon-induced liver disease ranges from mild acute hepatitis to (sub-) acute liver failure. J Hepatol 2004; 41: 67-74.
-
(2004)
J Hepatol
, vol.41
, pp. 67-74
-
-
Schimanski, C.C.1
Burg, J.2
Mohler, M.3
Höhler, T.4
Kanzler, S.5
Otto, G.6
Galle, P.R.7
Lohse, A.W.8
-
17
-
-
14144251491
-
Coumadin-induced hepatitis
-
Leikin A, Merei M, Dahan E, Blum A,. Coumadin-induced hepatitis. Eur J Intern Med 2005; 16: 61-2.
-
(2005)
Eur J Intern Med
, vol.16
, pp. 61-62
-
-
Leikin, A.1
Merei, M.2
Dahan, E.3
Blum, A.4
-
18
-
-
84904725750
-
Rivaroxaban postmarketing risk of liver injury
-
Russmann S, Niedrig DF, Budmiger M, Schmidt C, Stieger B, Hürlimann S, Kullak-Ublick GA,. Rivaroxaban postmarketing risk of liver injury. J Hepatol 2014; 61: 293-300.
-
(2014)
J Hepatol
, vol.61
, pp. 293-300
-
-
Russmann, S.1
Niedrig, D.F.2
Budmiger, M.3
Schmidt, C.4
Stieger, B.5
Hürlimann, S.6
Kullak-Ublick, G.A.7
-
19
-
-
84904756011
-
New oral anticoagulants (NOAC) and liver injury
-
Moore N, Blin P, Gulmez SE,. New oral anticoagulants (NOAC) and liver injury. J Hepatol 2014; 61: 198-9.
-
(2014)
J Hepatol
, vol.61
, pp. 198-199
-
-
Moore, N.1
Blin, P.2
Gulmez, S.E.3
-
20
-
-
84907964271
-
Symptomatic hepatocellular liver injury with hyperbilirubinemia in two patients treated with rivaroxaban
-
Liakoni E, Ratz Bravo AE, Terracciano L, Heim M, Krahenbuhl S,. Symptomatic hepatocellular liver injury with hyperbilirubinemia in two patients treated with rivaroxaban. JAMA Intern Med 2014; 174: 1683-6.
-
(2014)
JAMA Intern Med
, vol.174
, pp. 1683-1686
-
-
Liakoni, E.1
Ratz Bravo, A.E.2
Terracciano, L.3
Heim, M.4
Krahenbuhl, S.5
-
21
-
-
84878716004
-
Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS)
-
ed Karahoca A. Croatia: InTech.
-
Poluzzi E, Raschi E, Piccinni C, De Ponti F,. Data Mining Techniques in Pharmacovigilance: Analysis of the Publicly Accessible FDA Adverse Event Reporting System (AERS). In: Data Mining Applications in Engineering and Medicine, ed, Karahoca A,. Croatia: InTech, 2012.
-
(2012)
Data Mining Applications in Engineering and Medicine
-
-
Poluzzi, E.1
Raschi, E.2
Piccinni, C.3
De Ponti, F.4
-
22
-
-
77952847965
-
Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: Unified list based on international collaborative work
-
Suzuki A, Andrade RJ, Bjornsson E, Lucena MI, Lee WM, Yuen NA, Hunt CM, Freston JW,. Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work. Drug Saf 2010; 33: 503-22.
-
(2010)
Drug Saf
, vol.33
, pp. 503-522
-
-
Suzuki, A.1
Andrade, R.J.2
Bjornsson, E.3
Lucena, M.I.4
Lee, W.M.5
Yuen, N.A.6
Hunt, C.M.7
Freston, J.W.8
-
23
-
-
84890898067
-
Acute liver failure
-
Bernal W, Wendon J,. Acute liver failure. N Engl J Med 2013; 369: 2525-34.
-
(2013)
N Engl J Med
, vol.369
, pp. 2525-2534
-
-
Bernal, W.1
Wendon, J.2
-
24
-
-
84906813396
-
Assessing liver injury associated with antimycotics: Concise literature review and clues from data mining of the FAERS database
-
Raschi E, Poluzzi E, Koci A, Caraceni P, De Ponti F,. Assessing liver injury associated with antimycotics: concise literature review and clues from data mining of the FAERS database. World J Hepatol 2014; 6: 601-12.
-
(2014)
World J Hepatol
, vol.6
, pp. 601-612
-
-
Raschi, E.1
Poluzzi, E.2
Koci, A.3
Caraceni, P.4
De Ponti, F.5
-
25
-
-
84878321559
-
CANONIC Study Investigators of the EASL-CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis
-
2013;:, 1437.
-
Moreau R, Jalan R, Gines P, Pavesi M, Angeli P, Cordoba J, Durand F, Gustot T, Saliba F, Domenicali M, Gerbes A, Wendon J, Alessandria C, Laleman W, Zeuzem S, Trebicka J, Bernardi M, Arroyo V,. CANONIC Study Investigators of the EASL-CLIF Consortium. Acute-on-chronic liver failure is a distinct syndrome that develops in patients with acute decompensation of cirrhosis. Gastroenterology 2013; 144: 1426-37, 1437.
-
Gastroenterology
, vol.144
, pp. 1426-1437
-
-
Moreau, R.1
Jalan, R.2
Gines, P.3
Pavesi, M.4
Angeli, P.5
Cordoba, J.6
Durand, F.7
Gustot, T.8
Saliba, F.9
Domenicali, M.10
Gerbes, A.11
Wendon, J.12
Alessandria, C.13
Laleman, W.14
Zeuzem, S.15
Trebicka, J.16
Bernardi, M.17
Arroyo, V.18
-
26
-
-
17244369520
-
The history of disproportionality measures (reporting odds ratio, proportional reporting rates) in spontaneous reporting of adverse drug reactions
-
Moore N, Thiessard F, Begaud B,. The history of disproportionality measures (reporting odds ratio, proportional reporting rates) in spontaneous reporting of adverse drug reactions. Pharmacoepidemiol Drug Saf 2005; 14: 285-6.
-
(2005)
Pharmacoepidemiol Drug Saf
, vol.14
, pp. 285-286
-
-
Moore, N.1
Thiessard, F.2
Begaud, B.3
-
27
-
-
4544368008
-
The reporting odds ratio and its advantages over the proportional reporting ratio
-
Rothman KJ, Lanes S, Sacks ST,. The reporting odds ratio and its advantages over the proportional reporting ratio. Pharmacoepidemiol Drug Saf 2004; 13: 519-23.
-
(2004)
Pharmacoepidemiol Drug Saf
, vol.13
, pp. 519-523
-
-
Rothman, K.J.1
Lanes, S.2
Sacks, S.T.3
-
28
-
-
80855144263
-
Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database
-
Montastruc JL, Sommet A, Bagheri H, Lapeyre-Mestre M,. Benefits and strengths of the disproportionality analysis for identification of adverse drug reactions in a pharmacovigilance database. Br J Clin Pharmacol 2011; 72: 905-8.
-
(2011)
Br J Clin Pharmacol
, vol.72
, pp. 905-908
-
-
Montastruc, J.L.1
Sommet, A.2
Bagheri, H.3
Lapeyre-Mestre, M.4
-
29
-
-
80855131685
-
When to publish measures of disproportionality derived from spontaneous reporting databases?
-
de Boer A., When to publish measures of disproportionality derived from spontaneous reporting databases? Br J Clin Pharmacol 2011; 72: 909-11.
-
(2011)
Br J Clin Pharmacol
, vol.72
, pp. 909-911
-
-
De Boer, A.1
-
30
-
-
84926500315
-
Quantitative signal detection and analysis in pharmacovigilance
-
3rd edn, eds Andrews E. Moore N. London: Wiley.
-
Bate A, Pariente A, Hauben M, Bégaud B,. Quantitative signal detection and analysis in pharmacovigilance. In: Mann's Pharmacovigilance, 3rd edn, eds, Andrews E, Moore N,. London: Wiley, 2014; 331-54.
-
(2014)
Mann's Pharmacovigilance
, pp. 331-354
-
-
Bate, A.1
Pariente, A.2
Hauben, M.3
Bégaud, B.4
-
31
-
-
84902201519
-
Evaluation of Dabigatran Bleeding Adverse Reaction Reports in the FDA Adverse Event Reporting System during the First Year of Approval
-
McConeghy KW, Bress A, Qato DM, Wing C, Nutescu EA,. Evaluation of Dabigatran Bleeding Adverse Reaction Reports in the FDA Adverse Event Reporting System during the First Year of Approval. Pharmacotherapy 2014; 34: 561-9.
-
(2014)
Pharmacotherapy
, vol.34
, pp. 561-569
-
-
McConeghy, K.W.1
Bress, A.2
Qato, D.M.3
Wing, C.4
Nutescu, E.A.5
-
32
-
-
84879896592
-
A potential event-competition bias in safety signal detection: Results from a spontaneous reporting research database in France
-
Salvo F, Leborgne F, Thiessard F, Moore N, Begaud B, Pariente A,. A potential event-competition bias in safety signal detection: results from a spontaneous reporting research database in France. Drug Saf 2013; 36: 565-72.
-
(2013)
Drug Saf
, vol.36
, pp. 565-572
-
-
Salvo, F.1
Leborgne, F.2
Thiessard, F.3
Moore, N.4
Begaud, B.5
Pariente, A.6
-
33
-
-
84866138505
-
Association Française des Centres Régionaux de Pharmacovigilance (CRPV). Effect of competition bias in safety signal generation: Analysis of a research database of spontaneous reports in France
-
Pariente A, Avillach P, Salvo F, Thiessard F, Miremont-Salamé G, Fourrier-Reglat A, Haramburu F, Bégaud B, Moore N,. Association Française des Centres Régionaux de Pharmacovigilance (CRPV). Effect of competition bias in safety signal generation: analysis of a research database of spontaneous reports in France. Drug Saf 2012; 35: 855-64.
-
(2012)
Drug Saf
, vol.35
, pp. 855-864
-
-
Pariente, A.1
Avillach, P.2
Salvo, F.3
Thiessard, F.4
Miremont-Salamé, G.5
Fourrier-Reglat, A.6
Haramburu, F.7
Bégaud, B.8
Moore, N.9
-
34
-
-
84925934946
-
An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran
-
May 20, [Epub ahead of print]
-
McDonald CJ, Kalisch Ellett LM, Barratt JD, Caughey GE,. An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran. Pharmacoepidemiol Drug Saf 2014; May 20. doi: 10.1002/pds.3648. [Epub ahead of print].
-
(2014)
Pharmacoepidemiol Drug Saf
-
-
McDonald, C.J.1
Kalisch Ellett, L.M.2
Barratt, J.D.3
Caughey, G.E.4
-
35
-
-
84937530575
-
-
ISMP - Institute for Safety and Medication Practices. Quarter Watch - Quarter 1. Available at (last accessed 28 July 2014).
-
Moore T, Furberg C, Mattison D,. ISMP-Institute for Safety and Medication Practices. Quarter Watch-2013 Quarter 1. Update on anticoagulants, rivaroxaban (XARELTO) and dabigatran (PRADAXA). Available at http://www ismp org/quarterwatch/pdfs/2013Q1 pdf 2014 (last accessed 28 July 2014).
-
(2013)
Update on Anticoagulants, Rivaroxaban (XARELTO) and Dabigatran (PRADAXA)
-
-
Moore, T.1
Furberg, C.2
Mattison, D.3
-
36
-
-
33748675101
-
-
Available at (last accessed 28 July 2014).
-
Dabigatran-Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000829/WC500041059.pdf (last accessed 28 July 2014).
-
Dabigatran - Summary of Product Characteristics
-
-
-
37
-
-
84901933566
-
-
Available at (last accessed 28 July 2014).
-
Rivaroxaban-Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product-Information/human/000944/WC500057108.pdf (last accessed 28 July 2014).
-
Rivaroxaban - Summary of Product Characteristics
-
-
-
38
-
-
84937518539
-
-
Available at (last accessed 28 July 2014).
-
Rivaroxaban-US Prescribing Information. Available at http://www.accessdata.fda.gov/drugsatfda-docs/label/2014/022406s009lbl.pdf (last accessed 28 July 2014).
-
Rivaroxaban - US Prescribing Information
-
-
-
39
-
-
84937524675
-
-
Available at (last accessed 28 July 2014).
-
Dabigatran-US Prescribing Information. Available at http://www.accessdata.fda.gov/drugsatfda-docs/label/2014/022512s018lbl.pdf (last accessed 28 July 2014).
-
Dabigatran - US Prescribing Information
-
-
-
40
-
-
79951784125
-
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
-
Watkins PB, Desai M, Berkowitz SD, Peters G, Horsmans Y, Larrey D, Maddrey W,. 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: 243-52.
-
(2011)
Drug Saf
, vol.34
, pp. 243-252
-
-
Watkins, P.B.1
Desai, M.2
Berkowitz, S.D.3
Peters, G.4
Horsmans, Y.5
Larrey, D.6
Maddrey, W.7
-
41
-
-
68149124572
-
Quantitative signal detection using spontaneous ADR reporting
-
Bate A, Evans SJ,. Quantitative signal detection using spontaneous ADR reporting. Pharmacoepidemiol Drug Saf 2009; 18: 427-36.
-
(2009)
Pharmacoepidemiol Drug Saf
, vol.18
, pp. 427-436
-
-
Bate, A.1
Evans, S.J.2
-
42
-
-
84906075665
-
Potentially inappropriate medications and adverse drug reactions in the elderly: A study in a PharmacoVigilance database
-
Montastruc F, Duguet C, Rousseau V, Bagheri H, Montastruc JL,. Potentially inappropriate medications and adverse drug reactions in the elderly: a study in a PharmacoVigilance database. Eur J Clin Pharmacol 2014; 70: 1123-7.
-
(2014)
Eur J Clin Pharmacol
, vol.70
, pp. 1123-1127
-
-
Montastruc, F.1
Duguet, C.2
Rousseau, V.3
Bagheri, H.4
Montastruc, J.L.5
-
43
-
-
84877289110
-
Co-administration of rivaroxaban with drugs that share its elimination pathways: Pharmacokinetic effects in healthy subjects
-
Mueck W, Kubitza D, Becka M,. Co-administration of rivaroxaban with drugs that share its elimination pathways: pharmacokinetic effects in healthy subjects. Br J Clin Pharmacol 2013; 76: 455-66.
-
(2013)
Br J Clin Pharmacol
, vol.76
, pp. 455-466
-
-
Mueck, W.1
Kubitza, D.2
Becka, M.3
|