메뉴 건너뛰기




Volumn 14, Issue 9, 2013, Pages 1085-1097

Pharmacogenomics in early-phase clinical development

Author keywords

Clinical research; Drug development; Early phase; PD; PGt; PGx; Pharmacodynamics; Pharmacogenetics; Pharmacogenomics; Pharmacokinetics; PK; POC; Proof of concept

Indexed keywords

ABACAVIR; CLOPIDOGREL; CODEINE; GEFITINIB; IRINOTECAN; IVACAFTOR; MERCAPTOPURINE; TRASTUZUMAB; WARFARIN;

EID: 84880453290     PISSN: 14622416     EISSN: 17448042     Source Type: Journal    
DOI: 10.2217/pgs.13.81     Document Type: Review
Times cited : (40)

References (107)
  • 2
    • 16544390923 scopus 로고    scopus 로고
    • Human pharmacogenomics: The development of a science
    • Kalow W. Human pharmacogenomics: The development of a science. Hum. Genomics 1(5), 375-380 (2004
    • (2004) Hum. Genomics , vol.1 , Issue.5 , pp. 375-380
    • Kalow, W.1
  • 3
    • 33750332747 scopus 로고    scopus 로고
    • Pharmacogenetics and pharmacogenomics: Development, science, and translation
    • Weinshilboum RM, Wang L. Pharmacogenetics and pharmacogenomics: Development, science, and translation. Annu. Rev. Genomics Hum. Genet. 7, 223-245 (2006
    • (2006) Annu. Rev. Genomics Hum. Genet , vol.7 , pp. 223-245
    • Weinshilboum, R.M.1    Wang, L.2
  • 4
    • 84866593873 scopus 로고    scopus 로고
    • Pharmacogenomics and individualized medicine: Translating science into practice
    • Crews KR, Hicks JK, Pui CH, Relling MV, Evans WE. Pharmacogenomics and individualized medicine: Translating science into practice. Clin. Pharmacol. Ther. 92(4), 467-475 (2012
    • (2012) Clin. Pharmacol. Ther , vol.92 , Issue.4 , pp. 467-475
    • Crews, K.R.1    Hicks, J.K.2    Pui, C.H.3    Relling, M.V.4    Evans, W.E.5
  • 5
    • 0033569516 scopus 로고    scopus 로고
    • Pharmacogenomics: Translating functional genomics into rational therapeutics
    • Evans WE, Relling MV. Pharmacogenomics: Translating functional genomics into rational therapeutics. Science 286(5439), 487-491 (1999
    • (1999) Science , vol.286 , Issue.5439 , pp. 487-491
    • Evans, W.E.1    Relling, M.V.2
  • 6
    • 77956056999 scopus 로고    scopus 로고
    • Benefits of pharmacogenomics in drug developmentearlier launch of drugs and less adverse events
    • Ohashi W, Tanaka H. Benefits of pharmacogenomics in drug developmentearlier launch of drugs and less adverse events. J. Med. Syst. 34(4), 701-707 (2010
    • (2010) J. Med. Syst , vol.34 , Issue.4 , pp. 701-707
    • Ohashi, W.1    Tanaka, H.2
  • 7
    • 84867026276 scopus 로고    scopus 로고
    • Some applications of pharmacogenomics and epigenetics in drug development and use in pursuit of personalized medicine
    • Powanda MC, Moyer ED. Some applications of pharmacogenomics and epigenetics in drug development and use in pursuit of personalized medicine. Inflammopharmacology 20(5), 245-250 (2012
    • (2012) Inflammopharmacology , vol.20 , Issue.5 , pp. 245-250
    • Powanda, M.C.1    Moyer, E.D.2
  • 9
    • 15244348704 scopus 로고    scopus 로고
    • Emerging strategies and applications of pharmacogenomics
    • Milos PM, Seymour AB. Emerging strategies and applications of pharmacogenomics. Hum. Genomics 1(6), 444-455 (2004
    • (2004) Hum. Genomics , vol.1 , Issue.6 , pp. 444-455
    • Milos, P.M.1    Seymour, A.B.2
  • 10
    • 84857743534 scopus 로고    scopus 로고
    • US FDA. Guidance for Industry. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH
    • US FDA. Guidance for Industry. Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH) (2011
    • (2011) Clinical Pharmacogenomics: Premarketing Evaluation in Early Phase Clinical Studies
  • 11
    • 79960100831 scopus 로고    scopus 로고
    • Reengineering translational science: The time is right
    • 90cm17
    • Collins FS. Reengineering translational science: The time is right. Sci. Transl. Med. 3(90), 90cm17 (2011
    • (2011) Sci. Transl. Med , vol.3 , Issue.90
    • Collins, F.S.1
  • 13
    • 84866597034 scopus 로고    scopus 로고
    • Individualization of drug therapy: History, present state, and opportunities for the future
    • Lesko LJ, Schmidt S. Individualization of drug therapy: History, present state, and opportunities for the future. Clin. Pharmacol. Ther. 92(4), 458-466 (2012
    • (2012) Clin. Pharmacol. Ther , vol.92 , Issue.4 , pp. 458-466
    • Lesko, L.J.1    Schmidt, S.2
  • 14
    • 84855281666 scopus 로고    scopus 로고
    • Tibetan medicine: A unique heritage of person-centered medicine
    • Roberti di Sarsina P, Ottaviani L, Mella J. Tibetan medicine: A unique heritage of person-centered medicine. EPMA J. 2(4), 385-389 (2011
    • (2011) EPMA J. , vol.2 , Issue.4 , pp. 385-389
    • Roberti Di Sarsina, P.1    Ottaviani, L.2    Mella, J.3
  • 15
    • 84876368890 scopus 로고    scopus 로고
    • Insights on personalized medicine from Ayurveda
    • Sumantran VN, Tillu G. Insights on personalized medicine from Ayurveda. J. Altern. Complement. Med. 19(4), 370-375 (2013
    • (2013) J. Altern. Complement. Med , vol.19 , Issue.4 , pp. 370-375
    • Sumantran, V.N.1    Tillu, G.2
  • 16
    • 1342304255 scopus 로고    scopus 로고
    • Favism-from the 'avoid fava beans' of pythagoras to the present
    • Meletis J, Konstantopoulos K. Favism-from the 'avoid fava beans' of pythagoras to the present. Haema 7(1), 17-21 (2004
    • (2004) Haema , vol.7 , Issue.1 , pp. 17-21
    • Meletis, J.1    Konstantopoulos, K.2
  • 17
    • 0036182620 scopus 로고    scopus 로고
    • G6PD gene mutations in India producing drug-induced haemolytic anaemia
    • Sukumar S, Colah R, Mohanty D. G6PD gene mutations in India producing drug-induced haemolytic anaemia. Br. J. Haematol. 116(3), 671-672 (2002
    • (2002) Br. J. Haematol , vol.116 , Issue.3 , pp. 671-672
    • Sukumar, S.1    Colah, R.2    Mohanty, D.3
  • 18
    • 60049084202 scopus 로고    scopus 로고
    • Ibn Sina's canon of medicine: 11th century rules for assessing the effects of drugs
    • Nasser M, Tibi A, Savage-Smith E. Ibn Sina's canon of medicine: 11th century rules for assessing the effects of drugs. J. R. Soc. Med. 102(2), 78-80 (2009
    • (2009) J. R. Soc. Med , vol.102 , Issue.2 , pp. 78-80
    • Nasser, M.1    Tibi, A.2    Savage-Smith, E.3
  • 19
    • 80052738680 scopus 로고    scopus 로고
    • Traditional medicine to modern pharmacogenomics: Ayurveda prakriti type and CYP2C19 gene polymorphism associated with the metabolic variability
    • Ghodke Y, Joshi K, Patwardhan B. Traditional medicine to modern pharmacogenomics: Ayurveda prakriti type and CYP2C19 gene polymorphism associated with the metabolic variability. Evid. Based Complement. Alternat. Med. 2011, 249528 (2011
    • (2011) Evid. Based Complement. Alternat. Med , vol.2011 , pp. 249528
    • Ghodke, Y.1    Joshi, K.2    Patwardhan, B.3
  • 20
    • 70449136457 scopus 로고
    • Drug reactions enzymes, and biochemical genetics
    • Motulsky AG. Drug reactions enzymes, and biochemical genetics. J. Am. Med. Assoc. 165(7), 835-837 (1957
    • (1957) J. Am. Med. Assoc , vol.165 , Issue.7 , pp. 835-837
    • Motulsky, A.G.1
  • 21
    • 1542708761 scopus 로고    scopus 로고
    • From pharmacogenetics and ecogenetics to pharmacogenomics
    • Motulsky A. From pharmacogenetics and ecogenetics to pharmacogenomics. Med. Secoli. 14(3), 683-705 (2002
    • (2002) Med. Secoli , vol.14 , Issue.3 , pp. 683-705
    • Motulsky, A.1
  • 22
    • 37349033669 scopus 로고    scopus 로고
    • Drug reactions, enzymes, and biochemical genetics': 50 years later
    • Gurwitz D, Motulsky AG. 'Drug reactions, enzymes, and biochemical genetics': 50 years later. Pharmacogenomics 8(11), 1479-1484 (2007
    • (2007) Pharmacogenomics , vol.8 , Issue.11 , pp. 1479-1484
    • Gurwitz, D.1    Motulsky, A.G.2
  • 23
    • 0014383735 scopus 로고
    • Genetic control of dicumarol levels in man
    • Vesell ES, Page JG. Genetic control of dicumarol levels in man. J. Clin. Invest. 47(12), 2657-2663 (1968
    • (1968) J. Clin. Invest , vol.47 , Issue.12 , pp. 2657-2663
    • Vesell, E.S.1    Page, J.G.2
  • 24
    • 84866594260 scopus 로고    scopus 로고
    • Individualized dosing with anesthetic agents
    • Lemmens HJ, Stanski DR. Individualized dosing with anesthetic agents. Clin. Pharmacol. Ther. 92(4), 417-419 (2012
    • (2012) Clin. Pharmacol. Ther , vol.92 , Issue.4 , pp. 417-419
    • Lemmens, H.J.1    Stanski, D.R.2
  • 25
    • 33748416499 scopus 로고    scopus 로고
    • Cytokine storm in a Phase 1 trial of the anti- CD28 monoclonal antibody TGN1412
    • Suntharalingam G, Perry MR, Ward S et al. Cytokine storm in a Phase 1 trial of the anti- CD28 monoclonal antibody TGN1412. N. Engl. J. Med. 355(10), 1018-1028 (2006
    • (2006) N. Engl. J. Med , vol.355 , Issue.10 , pp. 1018-1028
    • Suntharalingam, G.1    Perry, M.R.2    Ward, S.3
  • 26
    • 33749648484 scopus 로고    scopus 로고
    • Establishing risk of human experimentation with drugs: Lessons from TGN1412
    • Kenter MJ, Cohen AF. Establishing risk of human experimentation with drugs: Lessons from TGN1412. Lancet 368(9544), 1387-1391 (2006
    • (2006) Lancet , vol.368 , Issue.9544 , pp. 1387-1391
    • Kenter, M.J.1    Cohen, A.F.2
  • 27
    • 45749083522 scopus 로고    scopus 로고
    • Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and third-generation Japanese populations: Comparison with Korean chinese, and caucasian populations
    • Myrand SP, Sekiguchi K, Man MZ et al. Pharmacokinetics/genotype associations for major cytochrome P450 enzymes in native and first- and third-generation Japanese populations: Comparison with Korean, Chinese, and Caucasian populations. Clin. Pharmacol. Ther. 84(3), 347-361 (2008
    • (2008) Clin. Pharmacol. Ther , vol.84 , Issue.3 , pp. 347-361
    • Myrand, S.P.1    Sekiguchi, K.2    Man, M.Z.3
  • 28
    • 79951809968 scopus 로고    scopus 로고
    • Clinical pharmacogenetics implementation consortium guidelines for thiopurine methyltransferase genotype and thiopurine dosing
    • Relling MV, Gardner EE, Sandborn WJ et al. Clinical pharmacogenetics implementation consortium guidelines for thiopurine methyltransferase genotype and thiopurine dosing. Clin. Pharmacol. Ther. 89(3), 387-391 (2011
    • (2011) Clin. Pharmacol. Ther , vol.89 , Issue.3 , pp. 387-391
    • Relling, M.V.1    Gardner, E.E.2    Sandborn, W.J.3
  • 29
    • 78349239505 scopus 로고    scopus 로고
    • The challenge of targeting EGFR: Experience with gefitinib in nonsmall cell lung cancer
    • Armour AA, Watkins CL. The challenge of targeting EGFR: Experience with gefitinib in nonsmall cell lung cancer. Eur. Respir. Rev. 19(117), 186-196 (2010
    • (2010) Eur. Respir. Rev , vol.19 , Issue.117 , pp. 186-196
    • Armour, A.A.1    Watkins, C.L.2
  • 30
    • 52949109845 scopus 로고    scopus 로고
    • Exploiting race in drug development: BiDil's interim model of pharmacogenomics
    • Kahn J. Exploiting race in drug development: BiDil's interim model of pharmacogenomics. Soc. Stud. Sci. 38(5), 737-758 (2008
    • (2008) Soc. Stud. Sci , vol.38 , Issue.5 , pp. 737-758
    • Kahn, J.1
  • 31
    • 27844564267 scopus 로고    scopus 로고
    • Implications of pharmacogenomics for drug development and clinical practice
    • Ginsburg GS, Konstance RP, Allsbrook JS, Schulman KA. Implications of pharmacogenomics for drug development and clinical practice. Arch. Intern. Med. 165(20), 2331-2336 (2005
    • (2005) Arch. Intern. Med , vol.165 , Issue.20 , pp. 2331-2336
    • Ginsburg, G.S.1    Konstance, R.P.2    Allsbrook, J.S.3    Schulman, K.A.4
  • 32
    • 77957995461 scopus 로고    scopus 로고
    • Cost effectiveness of pharmacogenomics: A critical and systematic review
    • Wong WB, Carlson JJ, Thariani R, Veenstra DL. Cost effectiveness of pharmacogenomics: A critical and systematic review. Pharmacoeconomics 28(11), 1001-1013 (2010
    • (2010) Pharmacoeconomics , vol.28 , Issue.11 , pp. 1001-1013
    • Wong, W.B.1    Carlson, J.J.2    Thariani, R.3    Veenstra, D.L.4
  • 33
    • 77953304931 scopus 로고    scopus 로고
    • Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study
    • Epstein RS, Moyer TP, Aubert RE et al. Warfarin genotyping reduces hospitalization rates results from the MM-WES (Medco-Mayo Warfarin Effectiveness study). J. Am. Coll. Cardiol. 55(25), 2804-2812 (2010
    • (2010) J. Am. Coll. Cardiol , vol.55 , Issue.25 , pp. 2804-2812
    • Epstein, R.S.1    Moyer, T.P.2    Aubert, R.E.3
  • 34
    • 58149352685 scopus 로고    scopus 로고
    • Pharmacogenomics: Candidate gene identification, functional validation and mechanisms
    • Wang L, Weinshilboum RM. Pharmacogenomics: Candidate gene identification, functional validation and mechanisms. Hum. Mol. Genet. 17(R2), R174-R179 (2008
    • (2008) Hum. Mol. Genet , vol.17 , Issue.R2
    • Wang, L.1    Weinshilboum, R.M.2
  • 35
    • 84869396522 scopus 로고    scopus 로고
    • Pharmacogenomics in clinical practice and drug development
    • Harper AR, Topol EJ. Pharmacogenomics in clinical practice and drug development. Nat. Biotechnol. 30(11), 1117-1124 (2012
    • (2012) Nat. Biotechnol , vol.30 , Issue.11 , pp. 1117-1124
    • Harper, A.R.1    Topol, E.J.2
  • 36
    • 84872040426 scopus 로고    scopus 로고
    • Chapter 11: Genome-wide association studies
    • Bush WS, Moore JH. Chapter 11: Genome-wide association studies. PLoS Comput. Biol. 8(12), e1002822 (2012
    • (2012) PLoS Comput. Biol , vol.8 , Issue.12
    • Bush, W.S.1    Moore, J.H.2
  • 38
    • 84866601265 scopus 로고    scopus 로고
    • Achieving the promise of personalized medicine
    • Reynolds KS. Achieving the promise of personalized medicine. Clin. Pharmacol. Ther. 92(4), 401-405 (2012
    • (2012) Clin. Pharmacol. Ther , vol.92 , Issue.4 , pp. 401-405
    • Reynolds, K.S.1
  • 39
    • 33846380861 scopus 로고    scopus 로고
    • Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes
    • Kirchheiner J, Seeringer A. Clinical implications of pharmacogenetics of cytochrome P450 drug metabolizing enzymes. Biochim. Biophys. Acta 1770(3), 489-494 (2007
    • (2007) Biochim. Biophys. Acta , vol.1770 , Issue.3 , pp. 489-494
    • Kirchheiner, J.1    Seeringer, A.2
  • 40
    • 3142519666 scopus 로고    scopus 로고
    • Pharmacogenetics of antidepressants and antipsychotics: The contribution of allelic variations to the phenotype of drug response
    • Kirchheiner J, Nickchen K, Bauer M et al. Pharmacogenetics of antidepressants and antipsychotics: The contribution of allelic variations to the phenotype of drug response. Mol. Psychiatry 9(5), 442-473 (2004
    • (2004) Mol. Psychiatry , vol.9 , Issue.5 , pp. 442-473
    • Kirchheiner, J.1    Nickchen, K.2    Bauer, M.3
  • 41
    • 57049097080 scopus 로고    scopus 로고
    • Pharmacogenetics-guided dose modifications of antidepressants
    • Seeringer A, Kirchheiner J. Pharmacogenetics-guided dose modifications of antidepressants. Clin. Lab. Med. 28(4), 619-626 (2008
    • (2008) Clin. Lab. Med , vol.28 , Issue.4 , pp. 619-626
    • Seeringer, A.1    Kirchheiner, J.2
  • 42
    • 80053539103 scopus 로고    scopus 로고
    • Adjuvant trastuzumab in HER2-positive breast cancer
    • Slamon D, Eiermann W, Robert N et al. Adjuvant trastuzumab in HER2-positive breast cancer. N. Engl. J. Med. 365(14), 1273-1283 (2011
    • (2011) N. Engl. J. Med , vol.365 , Issue.14 , pp. 1273-1283
    • Slamon, D.1    Eiermann, W.2    Robert, N.3
  • 43
    • 49549107264 scopus 로고    scopus 로고
    • Pharmacogenetics of oral anticoagulants: A basis for dose individualization
    • Stehle S, Kirchheiner J, Lazar A, Fuhr U. Pharmacogenetics of oral anticoagulants: A basis for dose individualization. Clin. Pharmacokinet. 47(9), 565-594 (2008
    • (2008) Clin. Pharmacokinet , vol.47 , Issue.9 , pp. 565-594
    • Stehle, S.1    Kirchheiner, J.2    Lazar, A.3    Fuhr, U.4
  • 44
    • 80052021468 scopus 로고    scopus 로고
    • Pharmacogenomic technologies: A necessary 'luxury' for better global public health?
    • Olivier C, Williams-Jones B. Pharmacogenomic technologies: A necessary 'luxury' for better global public health? Global Health 7(1), 30 (2011
    • (2011) Global Health , vol.7 , Issue.1 , pp. 30
    • Olivier, C.1    Williams-Jones, B.2
  • 45
    • 23844516328 scopus 로고    scopus 로고
    • Pharmacogenetics-based therapeutic recommendations-ready for clinical practice?
    • Kirchheiner J, Fuhr U, Brockmoller J. Pharmacogenetics-based therapeutic recommendations-ready for clinical practice? Nat. Rev. Drug Discov. 4(8), 639-647 (2005
    • (2005) Nat. Rev. Drug Discov , vol.4 , Issue.8 , pp. 639-647
    • Kirchheiner, J.1    Fuhr, U.2    Brockmoller, J.3
  • 46
    • 77949461421 scopus 로고    scopus 로고
    • Pharmacogenetics in psychiatry-A useful clinical tool or wishful thinking for the future?
    • Kirchheiner J, Seeringer A, Viviani R. Pharmacogenetics in psychiatry-a useful clinical tool or wishful thinking for the future? Curr. Pharm. Des. 16(2), 136-144 (2010
    • (2010) Curr. Pharm. Des , vol.16 , Issue.2 , pp. 136-144
    • Kirchheiner, J.1    Seeringer, A.2    Viviani, R.3
  • 48
    • 48249123433 scopus 로고    scopus 로고
    • 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 28(8), 992-998 (2008
    • (2008) Pharmacotherapy , vol.28 , Issue.8 , pp. 992-998
    • Frueh, F.W.1    Amur, S.2    Mummaneni, P.3
  • 49
    • 79951809825 scopus 로고    scopus 로고
    • CPIC: Clinical pharmacogenetics implementation consortium of the pharmacogenomics research network
    • Relling MV, Klein TE. CPIC: Clinical pharmacogenetics implementation consortium of the pharmacogenomics research network. Clin. Pharmacol. Ther. 89(3), 464-467 (2011
    • (2011) Clin. Pharmacol. Ther , vol.89 , Issue.3 , pp. 464-467
    • Relling, M.V.1    Klein, T.E.2
  • 51
    • 84866446560 scopus 로고    scopus 로고
    • Drug target prediction using adverse event report systems: A pharmacogenomic approach
    • Takarabe M, Kotera M, Nishimura Y, Goto S, Yamanishi Y. Drug target prediction using adverse event report systems: A pharmacogenomic approach. Bioinformatics 28(18), i611-i618 (2012
    • (2012) Bioinformatics , vol.28 , Issue.18
    • Takarabe, M.1    Kotera, M.2    Nishimura, Y.3    Goto, S.4    Yamanishi, Y.5
  • 52
    • 84861123738 scopus 로고    scopus 로고
    • Pharmacogenomics in early-phase oncology clinical trials: Is there a sweet spot in Phase II?
    • O'Donnell PH, Stadler WM. Pharmacogenomics in early-phase oncology clinical trials: Is there a sweet spot in Phase II? Clin. Cancer Res. 18(10), 2809-2816 (2012
    • (2012) Clin. Cancer Res , vol.18 , Issue.10 , pp. 2809-2816
    • O'Donnell, P.H.1    Stadler, W.M.2
  • 54
    • 77954903689 scopus 로고    scopus 로고
    • Membrane transporters and drug development: Relevance to pharmacogenomics, nutrigenomics, epigenetics, and systems biology
    • Yan Q. Membrane transporters and drug development: Relevance to pharmacogenomics, nutrigenomics, epigenetics, and systems biology. Methods Mol. Biol. 637, 1-21 (2010
    • (2010) Methods Mol. Biol , vol.637 , pp. 1-21
    • Yan, Q.1
  • 55
    • 84255175409 scopus 로고    scopus 로고
    • Interactions between metabolism and circadian clocks: Reciprocal disturbances
    • Delezie J, Challet E. Interactions between metabolism and circadian clocks: Reciprocal disturbances. Ann. NY Acad. Sci. 1243, 30-46 (2011
    • (2011) Ann. NY Acad. Sci , vol.1243 , pp. 30-46
    • Delezie, J.1    Challet, E.2
  • 56
    • 4344665180 scopus 로고    scopus 로고
    • Pharmacogenomics in drug development: Societal and technical aspects
    • Bartfai T. Pharmacogenomics in drug development: Societal and technical aspects. Pharmacogenomics J. 4(4), 226-232 (2004
    • (2004) Pharmacogenomics J. , vol.4 , Issue.4 , pp. 226-232
    • Bartfai, T.1
  • 57
    • 0036739552 scopus 로고    scopus 로고
    • Will pharmacogenomics alter the role of patents in drug development?
    • Eisenberg RS. Will pharmacogenomics alter the role of patents in drug development? Pharmacogenomics 3(5), 571-574 (2002
    • (2002) Pharmacogenomics , vol.3 , Issue.5 , pp. 571-574
    • Eisenberg, R.S.1
  • 58
    • 0036020644 scopus 로고    scopus 로고
    • Integrating pharmacogenomics into drug development
    • Ferentz AE. Integrating pharmacogenomics into drug development. Pharmacogenomics 3(4), 453-467 (2002
    • (2002) Pharmacogenomics , vol.3 , Issue.4 , pp. 453-467
    • Ferentz, A.E.1
  • 60
    • 0036848038 scopus 로고    scopus 로고
    • Pharmacogenomics in anticoagulant drug development
    • Iqbal O. Pharmacogenomics in anticoagulant drug development. Pharmacogenomics 3(6), 823-828 (2002
    • (2002) Pharmacogenomics , vol.3 , Issue.6 , pp. 823-828
    • Iqbal, O.1
  • 61
    • 27744557552 scopus 로고    scopus 로고
    • Pharmacogenomics: Integration into drug discovery and development
    • Johnson K, Thompson J, Power A. Pharmacogenomics: Integration into drug discovery and development. Curr. Top. Med. Chem. 5(11), 1039-1046 (2005
    • (2005) Curr. Top. Med. Chem , vol.5 , Issue.11 , pp. 1039-1046
    • Johnson, K.1    Thompson, J.2    Power, A.3
  • 62
    • 58749097312 scopus 로고    scopus 로고
    • Implications of pharmacogenomics for drug development
    • Kirk RJ, Hung JL, Horner SR, Perez JT. Implications of pharmacogenomics for drug development. Exp. Biol. Med. 233(12), 1484-1497 (2008
    • (2008) Exp. Biol. Med , vol.233 , Issue.12 , pp. 1484-1497
    • Kirk, R.J.1    Hung, J.L.2    Horner, S.R.3    Perez, J.T.4
  • 63
    • 0032818128 scopus 로고    scopus 로고
    • Can pharmacogenomics make a difference in drug development?
    • Ledley FD. Can pharmacogenomics make a difference in drug development? Nat. Biotechnol. 17(8), 731 (1999
    • (1999) Nat. Biotechnol , vol.17 , Issue.8 , pp. 731
    • Ledley, F.D.1
  • 64
    • 13844316592 scopus 로고    scopus 로고
    • Cancer pharmacogenomics: Powerful tools in cancer chemotherapy and drug development
    • Lee W, Lockhart AC, Kim RB, Rothenberg ML. Cancer pharmacogenomics: Powerful tools in cancer chemotherapy and drug development. Oncologist 10(2), 104-111 (2005
    • (2005) Oncologist , vol.10 , Issue.2 , pp. 104-111
    • Lee, W.1    Lockhart, A.C.2    Kim, R.B.3    Rothenberg, M.L.4
  • 65
    • 2942532516 scopus 로고    scopus 로고
    • Translating pharmacogenetics and pharmacogenomics into drug development for clinical pediatrics and beyond
    • Leeder JS. Translating pharmacogenetics and pharmacogenomics into drug development for clinical pediatrics and beyond. Drug Discov. Today 9(13), 567-573 (2004
    • (2004) Drug Discov. Today , vol.9 , Issue.13 , pp. 567-573
    • Leeder, J.S.1
  • 66
    • 0038397495 scopus 로고    scopus 로고
    • Pharmacogenetics and pharmacogenomics in drug discovery and development: An overview
    • Lindpaintner K. Pharmacogenetics and pharmacogenomics in drug discovery and development: An overview. Clin. Chem. Lab. Med. 41(4), 398-410 (2003
    • (2003) Clin. Chem. Lab. Med , vol.41 , Issue.4 , pp. 398-410
    • Lindpaintner, K.1
  • 67
    • 84857715780 scopus 로고    scopus 로고
    • The impact of pharmacogenomics research on drug development
    • Liou SY, Stringer F, Hirayama M. The impact of pharmacogenomics research on drug development. Drug Metab. Pharmacokinet. 27(1), 2-8 (2012
    • (2012) Drug Metab. Pharmacokinet , vol.27 , Issue.1 , pp. 2-8
    • Liou, S.Y.1    Stringer, F.2    Hirayama, M.3
  • 68
    • 33644867837 scopus 로고    scopus 로고
    • Pharmacogenomics and clinical biomarkers in drug discovery and development
    • Suppl
    • Ross JS, Symmans WF, Pusztai L, Hortobagyi GN. Pharmacogenomics and clinical biomarkers in drug discovery and development. Am. J. Clin. Pathol. 124(Suppl.), S29-S41 (2005
    • (2005) Am. J. Clin. Pathol , vol.124
    • Ross, J.S.1    Symmans, W.F.2    Pusztai, L.3    Hortobagyi, G.N.4
  • 69
    • 78951495386 scopus 로고    scopus 로고
    • Why, when, and how should pharmacogenetics be applied in clinical studies?: Current and future approaches to study designs
    • Stingl Kirchheiner JC, Brockmoller J. Why, when, and how should pharmacogenetics be applied in clinical studies?: Current and future approaches to study designs. Clin. Pharmacol. Ther. 89(2), 198-209 (2011
    • (2011) Clin. Pharmacol. Ther , vol.89 , Issue.2 , pp. 198-209
    • Stingl Kirchheiner, J.C.1    Brockmoller, J.2
  • 70
    • 0033771687 scopus 로고    scopus 로고
    • Scaling drug biotransformation data from cDNA-expressed cytochrome P-450 to human liver: A comparison of relative activity factors and human liver abundance in studies of mirtazapine metabolism
    • Stormer E, von Moltke LL, Greenblatt DJ. Scaling drug biotransformation data from cDNA-expressed cytochrome P-450 to human liver: A comparison of relative activity factors and human liver abundance in studies of mirtazapine metabolism. J. Pharmacol. Exp. Ther. 295(2), 793-801 (2000
    • (2000) J. Pharmacol. Exp. Ther , vol.295 , Issue.2 , pp. 793-801
    • Stormer, E.1    Von Moltke, L.L.2    Greenblatt, D.J.3
  • 71
    • 67649859295 scopus 로고    scopus 로고
    • HLA-B*5701 genotype is a major determinant of drug-induced liver injury due to flucloxacillin
    • Daly AK, Donaldson PT, Bhatnagar P et al. HLA-B*5701 genotype is a major determinant of drug-induced liver injury due to flucloxacillin. Nat. Genet. 41(7), 816-819 (2009
    • (2009) Nat. Genet , vol.41 , Issue.7 , pp. 816-819
    • Daly, A.K.1    Donaldson, P.T.2    Bhatnagar, P.3
  • 72
    • 38949188630 scopus 로고    scopus 로고
    • Pharmacogenomic biomarkers for prediction of severe adverse drug reactions
    • Ingelman-Sundberg M. Pharmacogenomic biomarkers for prediction of severe adverse drug reactions. N. Engl. J. Med. 358(6), 637-639 (2008
    • (2008) N. Engl. J. Med , vol.358 , Issue.6 , pp. 637-639
    • Ingelman-Sundberg, M.1
  • 73
    • 33846450220 scopus 로고    scopus 로고
    • Incorporating in vitro information on drug metabolism into clinical trial simulations to assess the effect of CYP2D6 polymorphism on pharmacokinetics and pharmacodynamics: Dextromethorphan as a model application
    • Dickinson GL, Rezaee S, Proctor NJ, Lennard MS, Tucker GT, Rostami-Hodjegan A. Incorporating in vitro information on drug metabolism into clinical trial simulations to assess the effect of CYP2D6 polymorphism on pharmacokinetics and pharmacodynamics: Dextromethorphan as a model application. J. Clin. Pharmacol. 47(2), 175-186 (2007
    • (2007) J. Clin. Pharmacol , vol.47 , Issue.2 , pp. 175-186
    • Dickinson, G.L.1    Rezaee, S.2    Proctor, N.J.3    Lennard, M.S.4    Tucker, G.T.5    Rostami-Hodjegan, A.6
  • 74
    • 34247641720 scopus 로고    scopus 로고
    • Application of pharmacogenomics in drug discovery and development: Correlations between transcriptional modulation and preclinical safety observations
    • Yengi LG, Xiang Q, Shen L, Chandrasekaran A, Kao J, Scatina J. Application of pharmacogenomics in drug discovery and development: Correlations between transcriptional modulation and preclinical safety observations. Drug Metab. Lett. 1(1), 41-48 (2007
    • (2007) Drug Metab. Lett , vol.1 , Issue.1 , pp. 41-48
    • Yengi, L.G.1    Xiang, Q.2    Shen, L.3    Chandrasekaran, A.4    Kao, J.5    Scatina, J.6
  • 75
    • 79952763405 scopus 로고    scopus 로고
    • Statistical optimization of pharmacogenomics association studies: Key considerations from study design to analysis
    • Grady BJ, Ritchie MD. Statistical optimization of pharmacogenomics association studies: Key considerations from study design to analysis. Curr. Pharmacogenomics Person. Med. 9(1), 41-66 (2011
    • (2011) Curr. Pharmacogenomics Person. Med , vol.9 , Issue.1 , pp. 41-66
    • Grady, B.J.1    Ritchie, M.D.2
  • 77
    • 84859707877 scopus 로고    scopus 로고
    • Microdosing clinical study: Pharmacokinetic, pharmacogenomic (SLCO2B1), and interaction (grapefruit juice) profiles of celiprolol following the oral microdose and therapeutic dose
    • Ieiri I, Doi Y, Maeda K et al. Microdosing clinical study: Pharmacokinetic, pharmacogenomic (SLCO2B1), and interaction (grapefruit juice) profiles of celiprolol following the oral microdose and therapeutic dose. J. Clin. Pharmacol. 52(7), 1078-1089 (2012
    • (2012) J. Clin. Pharmacol , vol.52 , Issue.7 , pp. 1078-1089
    • Ieiri, I.1    Doi, Y.2    Maeda, K.3
  • 78
    • 79960837480 scopus 로고    scopus 로고
    • Pharmacokinetic and pharmacogenomic profiles of telmisartan after the oral microdose and therapeutic dose
    • Ieiri I, Nishimura C, Maeda K et al. Pharmacokinetic and pharmacogenomic profiles of telmisartan after the oral microdose and therapeutic dose. Pharmacogenet. Genomics 21(8), 495-505 (2011
    • (2011) Pharmacogenet. Genomics , vol.21 , Issue.8 , pp. 495-505
    • Ieiri, I.1    Nishimura, C.2    Maeda, K.3
  • 79
    • 79957670781 scopus 로고    scopus 로고
    • Novel strategies for microdose studies using non-radiolabeled compounds
    • Maeda K, Sugiyama Y. Novel strategies for microdose studies using non-radiolabeled compounds. Adv. Drug Deliv. Rev. 63(7), 532-538 (2011
    • (2011) Adv. Drug Deliv. Rev , vol.63 , Issue.7 , pp. 532-538
    • Maeda, K.1    Sugiyama, Y.2
  • 80
    • 79957733024 scopus 로고    scopus 로고
    • Approaches using molecular imaging technology-use of PET in clinical microdose studies
    • Wagner CC, Langer O. Approaches using molecular imaging technology-use of PET in clinical microdose studies. Adv. Drug Deliv. Rev. 63(7), 539-546 (2011
    • (2011) Adv. Drug Deliv. Rev , vol.63 , Issue.7 , pp. 539-546
    • Wagner, C.C.1    Langer, O.2
  • 81
    • 33644827201 scopus 로고    scopus 로고
    • US FDA. Exploratory IND Studies. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER
    • US FDA. Guidance for Industry, Investigators, and Reviewers. Exploratory IND Studies. US Department of Health and Human Services, US FDA, Center for Drug Evaluation and Research (CDER) (2006
    • (2006) Guidance for Industry Investigators and Reviewers
  • 83
    • 84855968708 scopus 로고    scopus 로고
    • Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for codeine therapy in the context of cytochrome P450 2D6 (CYP2D6) genotype
    • Crews KR, Gaedigk A, Dunnenberger HM et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines for codeine therapy in the context of cytochrome P450 2D6 (CYP2D6) genotype. Clin. Pharmacol. Ther. 91(2), 321-326 (2012
    • (2012) Clin. Pharmacol. Ther , vol.91 , Issue.2 , pp. 321-326
    • Crews, K.R.1    Gaedigk, A.2    Dunnenberger, H.M.3
  • 84
    • 84866339466 scopus 로고    scopus 로고
    • Cost-effectiveness of pharmacogenetics in anticoagulation: International differences in healthcare systems and costs
    • Verhoef TI, Redekop WK, van Schie RM et al. Cost-effectiveness of pharmacogenetics in anticoagulation: International differences in healthcare systems and costs. Pharmacogenomics 13(12), 1405-1417 (2012
    • (2012) Pharmacogenomics , vol.13 , Issue.12 , pp. 1405-1417
    • Verhoef, T.I.1    Redekop, W.K.2    Van Schie, R.M.3
  • 86
    • 82755188037 scopus 로고    scopus 로고
    • Integration of pharmacogenetics and pharmacogenomics in drug development: Implications for regulatory and medical decision making in pediatric diseases
    • Piana C, Surh L, Furst-Recktenwald S et al. Integration of pharmacogenetics and pharmacogenomics in drug development: Implications for regulatory and medical decision making in pediatric diseases. J. Clin. Pharmacol. 52(5), 704-716 (2012
    • (2012) J. Clin. Pharmacol , vol.52 , Issue.5 , pp. 704-716
    • Piana, C.1    Surh, L.2    Furst-Recktenwald, S.3
  • 87
    • 78650323416 scopus 로고    scopus 로고
    • Learning from product labels and label changes: How to build pharmacogenomics into drug-development programs
    • Surh LC, Pacanowski MA, Haga SB et al. Learning from product labels and label changes: How to build pharmacogenomics into drug-development programs. Pharmacogenomics 11(12), 1637-1647 (2010
    • (2010) Pharmacogenomics , vol.11 , Issue.12 , pp. 1637-1647
    • Surh, L.C.1    Pacanowski, M.A.2    Haga, S.B.3
  • 88
    • 0347136017 scopus 로고    scopus 로고
    • Pharmacogenomics in drug development and regulatory decisionmaking: The Genomic Data Submission (GDS) Proposal
    • Salerno RA, Lesko LJ. Pharmacogenomics in drug development and regulatory decisionmaking: The Genomic Data Submission (GDS) Proposal. Pharmacogenomics 5(1), 25-30 (2004
    • (2004) Pharmacogenomics , vol.5 , Issue.1 , pp. 25-30
    • Salerno, R.A.1    Lesko, L.J.2
  • 89
    • 67749120865 scopus 로고    scopus 로고
    • The future costs, risks and rewards of drug development: The economics of pharmacogenomics
    • Cook J, Hunter G, Vernon JA. The future costs, risks and rewards of drug development: The economics of pharmacogenomics. Pharmacoeconomics 27(5), 355-363 (2009
    • (2009) Pharmacoeconomics , vol.27 , Issue.5 , pp. 355-363
    • Cook, J.1    Hunter, G.2    Vernon, J.A.3
  • 90
    • 77954827460 scopus 로고    scopus 로고
    • The path to personalized medicine
    • Hamburg MA, Collins FS. The path to personalized medicine. N. Engl. J. Med. 363(4), 301-304 (2010
    • (2010) N. Engl. J. Med , vol.363 , Issue.4 , pp. 301-304
    • Hamburg, M.A.1    Collins, F.S.2
  • 92
    • 58749094444 scopus 로고    scopus 로고
    • Cytochrome p-450 polymorphisms and response to clopidogrel
    • Mega JL, Close SL, Wiviott SD et al. Cytochrome p-450 polymorphisms and response to clopidogrel. N. Engl. J. Med. 360(4), 354-362 (2009
    • (2009) N. Engl. J. Med , vol.360 , Issue.4 , pp. 354-362
    • Mega, J.L.1    Close, S.L.2    Wiviott, S.D.3
  • 94
    • 38949196447 scopus 로고    scopus 로고
    • HLA-B*5701 screening for hypersensitivity to abacavir
    • Mallal S, Phillips E, Carosi G et al. HLA-B*5701 screening for hypersensitivity to abacavir. N. Engl. J. Med. 358(6), 568-579 (2008
    • (2008) N. Engl. J. Med , vol.358 , Issue.6 , pp. 568-579
    • Mallal, S.1    Phillips, E.2    Carosi, G.3
  • 95
    • 80455162465 scopus 로고    scopus 로고
    • A CFTR potentiator in patients with cystic fibrosis and the G551D mutation
    • Ramsey BW, Davies J, McElvaney NG et al. A CFTR potentiator in patients with cystic fibrosis and the G551D mutation. N. Engl. J. Med. 365(18), 1663-1672 (2011
    • (2011) N. Engl. J. Med , vol.365 , Issue.18 , pp. 1663-1672
    • Ramsey, B.W.1    Davies, J.2    McElvaney, N.G.3
  • 96
    • 33750583902 scopus 로고    scopus 로고
    • Uridine diphosphate glucuronosyltransferase (UGT) 1A1 and irinotecan: Practical pharmacogenomics arrives in cancer therapy
    • O'Dwyer PJ, Catalano RB. Uridine diphosphate glucuronosyltransferase (UGT) 1A1 and irinotecan: Practical pharmacogenomics arrives in cancer therapy. J. Clin. Oncol. 24(28), 4534-4538 (2006
    • (2006) J. Clin. Oncol , vol.24 , Issue.28 , pp. 4534-4538
    • O'Dwyer, P.J.1    Catalano, R.B.2
  • 97
    • 0036157862 scopus 로고    scopus 로고
    • Genetic polymorphisms of UDPglucuronosyltransferase in Asians: UGT1A1.*28 is a common allele in Indians
    • Balram C, Sabapathy K, Fei G, Khoo KS, Lee EJ. Genetic polymorphisms of UDPglucuronosyltransferase in Asians: UGT1A1.*28 is a common allele in Indians. Pharmacogenetics 12(1), 81-83 (2002
    • (2002) Pharmacogenetics , vol.12 , Issue.1 , pp. 81-83
    • Balram, C.1    Sabapathy, K.2    Fei, G.3    Khoo, K.S.4    Lee, E.J.5
  • 98
    • 0037362122 scopus 로고    scopus 로고
    • Implications of pharmacogenetics for individualizing drug treatment and for study design
    • Meisel C, Gerloff T, Kirchheiner J et al. Implications of pharmacogenetics for individualizing drug treatment and for study design. J. Mol. Med. 81(3), 154-167 (2003
    • (2003) J. Mol. Med , vol.81 , Issue.3 , pp. 154-167
    • Meisel, C.1    Gerloff, T.2    Kirchheiner, J.3
  • 99
    • 84862076531 scopus 로고    scopus 로고
    • Impact of drug transporter pharmacogenomics on pharmacokinetic and pharmacodynamic variability-considerations for drug development
    • Lai Y, Varma M, Feng B et al. Impact of drug transporter pharmacogenomics on pharmacokinetic and pharmacodynamic variability-considerations for drug development. Expert Opin. Drug Metab. Toxicol. 8(6), 723-743 (2012
    • (2012) Expert Opin. Drug Metab. Toxicol , vol.8 , Issue.6 , pp. 723-743
    • Lai, Y.1    Varma, M.2    Feng, B.3
  • 100
    • 70649084116 scopus 로고    scopus 로고
    • Genotype-guided dosing of coumarin derivatives: The European pharmacogenetics of anticoagulant therapy (EU-PACT) trial design
    • van Schie RM, Wadelius MI, Kamali F et al. Genotype-guided dosing of coumarin derivatives: The European pharmacogenetics of anticoagulant therapy (EU-PACT) trial design. Pharmacogenomics 10(10), 1687-1695 (2009
    • (2009) Pharmacogenomics , vol.10 , Issue.10 , pp. 1687-1695
    • Van Schie, R.M.1    Wadelius, M.I.2    Kamali, F.3
  • 101
    • 34548706007 scopus 로고    scopus 로고
    • Apolipoprotein E and neurological disease: Therapeutic potential and pharmacogenomic interactions
    • Laskowitz DT, Vitek MP. Apolipoprotein E and neurological disease: Therapeutic potential and pharmacogenomic interactions. Pharmacogenomics 8(8), 959-969 (2007
    • (2007) Pharmacogenomics , vol.8 , Issue.8 , pp. 959-969
    • Laskowitz, D.T.1    Vitek, M.P.2
  • 102
    • 39449086981 scopus 로고    scopus 로고
    • CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: A prospective randomized controlled study
    • Caraco Y, Blotnick S, Muszkat M. CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: A prospective randomized controlled study. Clin. Pharmacol. Ther. 83(3), 460-470 (2008
    • (2008) Clin. Pharmacol. Ther , vol.83 , Issue.3 , pp. 460-470
    • Caraco, Y.1    Blotnick, S.2    Muszkat, M.3
  • 103
    • 70449513464 scopus 로고    scopus 로고
    • Back to the future: Why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine
    • Frueh FW. Back to the future: Why randomized controlled trials cannot be the answer to pharmacogenomics and personalized medicine. Pharmacogenomics 10(7), 1077-1081 (2009
    • (2009) Pharmacogenomics , vol.10 , Issue.7 , pp. 1077-1081
    • Frueh, F.W.1
  • 104
    • 76549090371 scopus 로고    scopus 로고
    • Role of regulatory agencies in translating pharmacogenetics to the clinics
    • Prasad K. Role of regulatory agencies in translating pharmacogenetics to the clinics. Clin. Cases Miner. Bone Metab. 6(1), 29-34 (2009
    • (2009) Clin. Cases Miner. Bone Metab , vol.6 , Issue.1 , pp. 29-34
    • Prasad, K.1
  • 105
    • 84865442326 scopus 로고    scopus 로고
    • Pharmacogenomics and personalized medicine: Wicked problems, ragged edges and ethical precipices
    • Fleck LM. Pharmacogenomics and personalized medicine: Wicked problems, ragged edges and ethical precipices. N. Biotechnol. 29(6), 757-768 (2012
    • (2012) N. Biotechnol , vol.29 , Issue.6 , pp. 757-768
    • Fleck, L.M.1
  • 106
    • 0141478716 scopus 로고    scopus 로고
    • Ethical, social and legal issues in pharmacogenomics
    • Wertz DC. Ethical, social and legal issues in pharmacogenomics. Pharmacogenomics J. 3(4), 194-196 (2003
    • (2003) Pharmacogenomics J. , vol.3 , Issue.4 , pp. 194-196
    • Wertz, D.C.1
  • 107
    • 44949207490 scopus 로고    scopus 로고
    • Pharmacogenomics, ethics, and public policy
    • Peterson-Iyer K. Pharmacogenomics, ethics, and public policy. Kennedy Inst. Ethics J. 18(1), 35-56 (2008
    • (2008) Kennedy Inst. Ethics J. , vol.18 , Issue.1 , pp. 35-56
    • Peterson-Iyer, K.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.