-
1
-
-
1542333321
-
-
U.S. Food and Drug Administration March accessed 4 March 2013
-
U.S. Food and Drug Administration. Guidance for Industry: Pharmacogenomic Data Submissions. March 2005. Available at: http://www.fda.gov/downloads/ Regula-toryInformation/Guidances/ucm126957.pdf (accessed 4 March 2013).
-
(2005)
Guidance for Industry: Pharmacogenomic Data Submissions
-
-
-
2
-
-
84886948717
-
-
U.S. Food and Drug Administration accessed 4 March 2013
-
U.S. Food and Drug Administration. Genomics. Available at: http://www.fda.gov/Drugs/ScienceResearch/ResearchAreas/Pharmacogenetics/default. htm (accessed 4 March 2013).
-
Genomics
-
-
-
3
-
-
79952254324
-
-
U.S. Food and Drug Administration accessed 4 March 2013
-
U.S. Food and Drug Administration. Table of Pharmacogenomic Biomarkers in Drug Labels. Available at: http://www.fda.gov/Drugs/ScienceResearch/ ResearchAreas/Pharmacogenetics/ucm083378.htm (accessed 4 March 2013).
-
Table of Pharmacogenomic Biomarkers in Drug Labels
-
-
-
4
-
-
84886948704
-
-
European Medicines Agency accessed 4 March 2013
-
European Medicines Agency. Multidisciplinary: Pharmacogenomics. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/ general-content-000411.jsp&mid=WC0b01ac058002958e&jsen-abled=true (accessed 4 March 2013).
-
Multidisciplinary: Pharmacogenomics
-
-
-
5
-
-
48249123433
-
Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: Prevalence of related drug use
-
Frueh FW, Amur S, Mummaneni P, et al,. Pharmacogenomic biomarker information in drug labels approved by the United States Food and Drug Administration: prevalence of related drug use. Pharmacotherapy, 2008; 28: 992-998.
-
(2008)
Pharmacotherapy
, vol.28
, pp. 992-998
-
-
Frueh, F.W.1
Amur, S.2
Mummaneni, P.3
-
6
-
-
10044251042
-
Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs
-
Zineh I, Gerhard T, Aquilante CL, Beitelshees AL, Beasley BN, Hartzema AG,. Availability of pharmacogenomics-based prescribing information in drug package inserts for currently approved drugs. Pharmacogenomics J, 2004; 4: 354-358.
-
(2004)
Pharmacogenomics J
, vol.4
, pp. 354-358
-
-
Zineh, I.1
Gerhard, T.2
Aquilante, C.L.3
Beitelshees, A.L.4
Beasley, B.N.5
Hartzema, A.G.6
-
7
-
-
33646232022
-
Discordance between availability of pharmacogenetics studies and pharmacogenetics-based prescribing information for the top 200 drugs
-
Zineh I, Pebanco GD, Aquilante CL, Gerhard T, Beitelshees AL,. Discordance between availability of pharmacogenetics studies and pharmacogenetics-based prescribing information for the top 200 drugs. Ann Pharmacother, 2006; 40: 639-644.
-
(2006)
Ann Pharmacother
, vol.40
, pp. 639-644
-
-
Zineh, I.1
Pebanco, G.D.2
Aquilante, C.L.3
Gerhard, T.4
Beitelshees, A.L.5
-
8
-
-
49549109198
-
Current Japanese regulatory situations of pharmacogenomics in drug administration
-
Ishiguro A, Toyoshima S, Uyama Y,. Current Japanese regulatory situations of pharmacogenomics in drug administration. Expert Rev Clin Pharmacol, 2008; 1: 505-514.
-
(2008)
Expert Rev Clin Pharmacol
, vol.1
, pp. 505-514
-
-
Ishiguro, A.1
Toyoshima, S.2
Uyama, Y.3
-
9
-
-
84857758926
-
Similarities and differences between US and Japan as to pharmacogenomic biomarker information in drug labels
-
Otsubo Y, Asahina Y, Noguchi A, Sato Y, Ando Y, Uyama Y,. Similarities and differences between US and Japan as to pharmacogenomic biomarker information in drug labels. Drug Metab Pharmacokinet, 2012; 27: 142-149.
-
(2012)
Drug Metab Pharmacokinet
, vol.27
, pp. 142-149
-
-
Otsubo, Y.1
Asahina, Y.2
Noguchi, A.3
Sato, Y.4
Ando, Y.5
Uyama, Y.6
-
11
-
-
77953643213
-
Comparing health care systems. Can the United States learn from other countries?
-
Weaver L, Donohue E, Hedtke B, et al,. Comparing health care systems. Can the United States learn from other countries? Minn Med, 2010; 93: 6-7.
-
(2010)
Minn Med
, vol.93
, pp. 6-7
-
-
Weaver, L.1
Donohue, E.2
Hedtke, B.3
-
12
-
-
77951700065
-
-
U.S. Food and Drug Administration accessed 4 March 2013
-
U.S. Food and Drug Administration. Drugs@FDA: FDA Approved Drug Products. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/ (accessed 4 March 2013).
-
Drugs@FDA: FDA Approved Drug Products
-
-
-
13
-
-
84869638704
-
-
accessed 4 March 2013
-
National Library of Medicine. Daily Med. Available at: http://dailymed.nlm.nih.gov/dailymed/about.cfm (accessed 4 March 2013).
-
National Library of Medicine. Daily Med
-
-
-
15
-
-
84886947071
-
-
Pharmaceutical Medical Device Agency accessed 4 March 2013
-
Pharmaceutical Medical Device Agency. Information of Ethical Drug Package Inserts. Available at: http://www.info.pmda.go.jp/psearch/html/menu-tenpu-base. html (accessed 4 March 2013).
-
Information of Ethical Drug Package Inserts
-
-
-
16
-
-
33644872081
-
Requirements on content and format of labeling for human prescription drug and biological products
-
U. S. Department of Health and Human Services.:. Available at: http://edocket.access.gpo.gov/2006/pdf/06-545.pdf (accessed 4 March 2013).
-
U. S. Department of Health and Human Services. Requirements on content and format of labeling for human prescription drug and biological products. Fed Reg, 2006; 71: 3922-3997. Available at: http://edocket.access.gpo.gov/2006/pdf/ 06-545.pdf (accessed 4 March 2013).
-
(2006)
Fed Reg
, vol.71
, pp. 3922-3997
-
-
-
17
-
-
33748675101
-
-
European Commission September accessed 4 March 2013
-
European Commission. A Guideline on Summary of Product Characteristics. September 2009. Available at: http://ec.europa.eu/health/files/eudralex/vol-2/c/ smpc-guide-line-rev2-en.pdf (accessed 4 March 2013).
-
(2009)
A Guideline on Summary of Product Characteristics
-
-
-
18
-
-
77949304161
-
-
Ministry of Health & Welfare. Notification No. 606 (in Japanese). Dated 25 April
-
Pharmaceutical Affairs Bureau, Ministry of Health & Welfare. Notification No. 606 (in Japanese). Dated 25 April 1997.
-
(1997)
Pharmaceutical Affairs Bureau
-
-
-
21
-
-
77952189195
-
Approval of new drugs 1999-2007: Comparison of the US, the EU and Japan situations
-
Tsuji K, Tsutani K,. Approval of new drugs 1999-2007: comparison of the US, the EU and Japan situations. J Clin Pharm Ther, 2010; 35: 289-301.
-
(2010)
J Clin Pharm Ther
, vol.35
, pp. 289-301
-
-
Tsuji, K.1
Tsutani, K.2
-
22
-
-
0030955080
-
Ethnic distribution of factor v Leiden in 4047 men and women. Implications for venous thromboembolism screening
-
Ridker PM, Miletich JP, Hennekens CH, Buring JE,. Ethnic distribution of factor V Leiden in 4047 men and women. Implications for venous thromboembolism screening. JAMA, 1997; 277: 1305-1307.
-
(1997)
JAMA
, vol.277
, pp. 1305-1307
-
-
Ridker, P.M.1
Miletich, J.P.2
Hennekens, C.H.3
Buring, J.E.4
-
23
-
-
85006639536
-
Bioinformatics research on inter-racial difference in drug metabolism I. Analysis on frequencies of mutant alleles and poor metabolizers on CYP2D6 and CYP2C19
-
Shimizu T, Ochiai H, Asell F, et al,. Bioinformatics research on inter-racial difference in drug metabolism I. Analysis on frequencies of mutant alleles and poor metabolizers on CYP2D6 and CYP2C19. Drug Metab Pharmacokinet, 2003; 18: 48-70.
-
(2003)
Drug Metab Pharmacokinet
, vol.18
, pp. 48-70
-
-
Shimizu, T.1
Ochiai, H.2
Asell, F.3
-
29
-
-
77955638355
-
ACCF/AHA clopidogrel clinical alert: Approaches to the FDA 'boxed warning': A report of the American College of Cardiology Foundation Task Force on clinical expert consensus documents and the American Heart Association endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons
-
Holmes DR Jr, Dehmer GJ, Kaul S, Leifer D, O'Gara PT, Stein CM,. ACCF/AHA clopidogrel clinical alert: approaches to the FDA 'boxed warning': a report of the American College of Cardiology Foundation Task Force on clinical expert consensus documents and the American Heart Association endorsed by the Society for Cardiovascular Angiography and Interventions and the Society of Thoracic Surgeons. J Am Coll Cardiol, 2010; 56: 321-341.
-
(2010)
J Am Coll Cardiol
, vol.56
, pp. 321-341
-
-
Holmes Jr., D.R.1
Dehmer, G.J.2
Kaul, S.3
Leifer, D.4
O'Gara, P.T.5
Stein, C.M.6
-
30
-
-
84858999257
-
Impact of CYP2C19 variant genotypes on clinical efficacy of antiplatelet treatment with clopidogrel: Systematic review and meta-analysis
-
Bauer T, Bouman HJ, van Werkum JW, Ford NF, ten Berg JM, Taubert D,. Impact of CYP2C19 variant genotypes on clinical efficacy of antiplatelet treatment with clopidogrel: systematic review and meta-analysis. BMJ, 2011; 343: d4588.
-
(2011)
BMJ
, vol.343
-
-
Bauer, T.1
Bouman, H.J.2
Van Werkum, J.W.3
Ford, N.F.4
Ten Berg, J.M.5
Taubert, D.6
-
31
-
-
33847034287
-
The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen
-
Goetz MP, Knox SK, Suman VJ, et al,. The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat, 2007; 101: 113-121.
-
(2007)
Breast Cancer Res Treat
, vol.101
, pp. 113-121
-
-
Goetz, M.P.1
Knox, S.K.2
Suman, V.J.3
-
32
-
-
33747045564
-
Polymorphism in the CYP2D6 tamoxifen-metabolizing gene influences clinical effect but not hot flashes: Data from the Italian Tamoxifen Trial
-
Bonanni B, Macis D, Maisonneuve P, et al,. Polymorphism in the CYP2D6 tamoxifen-metabolizing gene influences clinical effect but not hot flashes: data from the Italian Tamoxifen Trial. J Clin Oncol, 2006; 24: 3708-3709.
-
(2006)
J Clin Oncol
, vol.24
, pp. 3708-3709
-
-
Bonanni, B.1
Macis, D.2
Maisonneuve, P.3
-
33
-
-
21344467511
-
Association of genetic variation in tamoxifen-metabolizing enzymes with overall survival and recurrence of disease in breast cancer patients
-
Nowell SA, Ahn J, Rae JM, et al,. Association of genetic variation in tamoxifen-metabolizing enzymes with overall survival and recurrence of disease in breast cancer patients. Breast Cancer Res Treat, 2005; 91: 249-258.
-
(2005)
Breast Cancer Res Treat
, vol.91
, pp. 249-258
-
-
Nowell, S.A.1
Ahn, J.2
Rae, J.M.3
-
34
-
-
34248208754
-
Genetic variants of CYP3A5, CYP2D6, SULT1A1, UGT2B15 and tamoxifen response in postmenopausal patients with breast cancer
-
Wegman P, Elingarami S, Carstensen J, Stål O, Nordenskjöld B, Wingren S,. Genetic variants of CYP3A5, CYP2D6, SULT1A1, UGT2B15 and tamoxifen response in postmenopausal patients with breast cancer. Breast Cancer Res, 2007; 9: R7.
-
(2007)
Breast Cancer Res
, vol.9
-
-
Wegman, P.1
Elingarami, S.2
Carstensen, J.3
Stål, O.4
Nordenskjöld, B.5
Wingren, S.6
-
35
-
-
29144491089
-
Genotype of metabolic enzymes and the benefit of tamoxifen in postmenopausal breast cancer patients
-
Wegman P, Vainikka L, Stål O, et al,. Genotype of metabolic enzymes and the benefit of tamoxifen in postmenopausal breast cancer patients. Breast Cancer Res, 2005; 7: R284-R290.
-
(2005)
Breast Cancer Res
, vol.7
-
-
Wegman, P.1
Vainikka, L.2
Stål, O.3
-
36
-
-
36349024762
-
Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes
-
Schroth W, Antoniadou L, Fritz P, et al,. Breast cancer treatment outcome with adjuvant tamoxifen relative to patient CYP2D6 and CYP2C19 genotypes. J Clin Oncol, 2007; 25: 5187-5193.
-
(2007)
J Clin Oncol
, vol.25
, pp. 5187-5193
-
-
Schroth, W.1
Antoniadou, L.2
Fritz, P.3
-
37
-
-
43649090742
-
Impact of CYP2D6*10 on recurrence-free survival in breast cancer patients receiving adjuvant tamoxifen therapy
-
Kiyotani K, Mushiroda T, Sasa M, et al,. Impact of CYP2D6*10 on recurrence-free survival in breast cancer patients receiving adjuvant tamoxifen therapy. Cancer Sci, 2008; 99: 995-999.
-
(2008)
Cancer Sci
, vol.99
, pp. 995-999
-
-
Kiyotani, K.1
Mushiroda, T.2
Sasa, M.3
-
38
-
-
34548532227
-
Clinical implications of CYP2D6 genotypes predictive of tamoxifen pharmacokinetics in metastatic breast cancer
-
Lim HS, Ju Lee H, Seok Lee K, Sook Lee E, Jang IJ, Ro J,. Clinical implications of CYP2D6 genotypes predictive of tamoxifen pharmacokinetics in metastatic breast cancer. J Clin Oncol, 2007; 25: 3837-3845.
-
(2007)
J Clin Oncol
, vol.25
, pp. 3837-3845
-
-
Lim, H.S.1
Ju Lee, H.2
Seok Lee, K.3
Sook Lee, E.4
Jang, I.J.5
Ro, J.6
-
39
-
-
36849092797
-
Germline pharmacogenetics of tamoxifen response: Have we learned enough?
-
Desta Z, Flockhart DA,. Germline pharmacogenetics of tamoxifen response: have we learned enough? J Clin Oncol, 2007; 25: 5147-5149.
-
(2007)
J Clin Oncol
, vol.25
, pp. 5147-5149
-
-
Desta, Z.1
Flockhart, D.A.2
-
40
-
-
44049098957
-
A model citizen? Is tamoxifen more effective than aromatase inhibitors if we pick the right patients?
-
Consortium on Breast Cancer Pharmacogenomics
-
Hayes DF, Stearns V, Rae J, Flockhart D, Consortium on Breast Cancer Pharmacogenomics. A model citizen? Is tamoxifen more effective than aromatase inhibitors if we pick the right patients? J Natl Cancer Inst, 2008; 100: 610-613.
-
(2008)
J Natl Cancer Inst
, vol.100
, pp. 610-613
-
-
Hayes, D.F.1
Stearns, V.2
Rae, J.3
Flockhart, D.4
-
41
-
-
67650642313
-
Clinically available pharmacogenomics tests
-
Flockhart DA, Skaar T, Berlin DS, Klein TE, Nguyen AT,. Clinically available pharmacogenomics tests. Clin Pharmacol Ther, 2009; 86: 109-113.
-
(2009)
Clin Pharmacol Ther
, vol.86
, pp. 109-113
-
-
Flockhart, D.A.1
Skaar, T.2
Berlin, D.S.3
Klein, T.E.4
Nguyen, A.T.5
-
42
-
-
33745404259
-
Genetic determinants of dose and clinical outcomes in patients receiving oral anticoagulants
-
Schwarz UI, Stein CM,. Genetic determinants of dose and clinical outcomes in patients receiving oral anticoagulants. Clin Pharmacol Ther, 2006; 80: 7-12.
-
(2006)
Clin Pharmacol Ther
, vol.80
, pp. 7-12
-
-
Schwarz, U.I.1
Stein, C.M.2
-
43
-
-
40449120615
-
Genetic determinants of response to warfarin during initial anticoagulation
-
Schwarz UI, Ritchie MD, Bradford Y, et al,. Genetic determinants of response to warfarin during initial anticoagulation. N Engl J Med, 2008; 358: 999-1008.
-
(2008)
N Engl J Med
, vol.358
, pp. 999-1008
-
-
Schwarz, U.I.1
Ritchie, M.D.2
Bradford, Y.3
-
44
-
-
80052962391
-
Clinical Pharmacogenetics Implementation Consortium guidelines for CYP2C9 and VKORC1 genotypes and warfarin dosing
-
Johnson JA, Gong L, Whirl-Carrillo M, et al,. Clinical Pharmacogenetics Implementation Consortium guidelines for CYP2C9 and VKORC1 genotypes and warfarin dosing. Clin Pharmacol Ther, 2011; 90: 625-629.
-
(2011)
Clin Pharmacol Ther
, vol.90
, pp. 625-629
-
-
Johnson, J.A.1
Gong, L.2
Whirl-Carrillo, M.3
-
46
-
-
77953624552
-
Role of warfarin pharmacogenetic testing in clinical practice
-
Tan GM, Wu E, Lam YY, Yan BP,. Role of warfarin pharmacogenetic testing in clinical practice. Pharmacotherapy, 2010; 11: 439-448.
-
(2010)
Pharmacotherapy
, vol.11
, pp. 439-448
-
-
Tan, G.M.1
Wu, E.2
Lam, Y.Y.3
Yan, B.P.4
-
47
-
-
84862777241
-
A randomized and clinical effectiveness trial comparing two pharmacogenetic algorithms and standard care for individualizing warfarin dosing (CoumaGen-II)
-
Anderson JL, Horne BD, Stevens SM, et al,. A randomized and clinical effectiveness trial comparing two pharmacogenetic algorithms and standard care for individualizing warfarin dosing (CoumaGen-II). Circulation, 2012; 125: 1997-2005.
-
(2012)
Circulation
, vol.125
, pp. 1997-2005
-
-
Anderson, J.L.1
Horne, B.D.2
Stevens, S.M.3
-
48
-
-
80054989280
-
A proposal for an individualized pharmacogenetics-based warfarin initiation dose regimen for patients commencing anticoagulation therapy
-
EU-PACT Study Group
-
Avery PJ, Jorgensen A, Hamberg AK, Wadelius M, Pirmohamed M, Kamali F, EU-PACT Study Group. A proposal for an individualized pharmacogenetics-based warfarin initiation dose regimen for patients commencing anticoagulation therapy. Clin Pharmacol Ther, 2011; 90: 701-706.
-
(2011)
Clin Pharmacol Ther
, vol.90
, pp. 701-706
-
-
Avery, P.J.1
Jorgensen, A.2
Hamberg, A.K.3
Wadelius, M.4
Pirmohamed, M.5
Kamali, F.6
-
49
-
-
60849097257
-
Estimation of the warfarin dose with clinical and pharmacogenetic data
-
Klein TE, Altman RB, Eriksson N, et al,. Estimation of the warfarin dose with clinical and pharmacogenetic data. N Engl J Med, 2009; 360: 753-764.
-
(2009)
N Engl J Med
, vol.360
, pp. 753-764
-
-
Klein, T.E.1
Altman, R.B.2
Eriksson, N.3
-
50
-
-
73949124118
-
Personalized medicine: Factors influencing reimbursement
-
Meckley LM, Neumann PJ,. Personalized medicine: factors influencing reimbursement. Health Policy, 2010; 94: 91-100.
-
(2010)
Health Policy
, vol.94
, pp. 91-100
-
-
Meckley, L.M.1
Neumann, P.J.2
|