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Volumn 10, Issue 7, 2011, Pages 495-506

Bridging the efficacyg-effectiveness gap: A regulator's perspective on addressing variability of drug response

(9)  Eichler, Hans Georg a,b   Abadie, Eric a,c   Breckenridge, Alasdair d   Flamion, Bruno a,e   Gustafsson, Lars L f   Leufkens, Hubert a,g   Rowland, Malcolm h   Schneider, Christian K a,i,j   Bloechl Daum, Brigitte a,k  


Author keywords

[No Author keywords available]

Indexed keywords

ABACAVIR; ANTIHYPERTENSIVE AGENT; ANTIINFECTIVE AGENT; ANTIRETROVIRUS AGENT; CERIVASTATIN; CHONDROITIN SULFATE; COCAINE; GEFITINIB; GEMFIBROZIL; HEPARIN; INFLIXIMAB; INSULIN; METHOTREXATE; MIBEFRADIL; NELFINAVIR; ORAL CONTRACEPTIVE AGENT; RIMONABANT; ROFECOXIB; TRASTUZUMAB; TUMOR NECROSIS FACTOR INHIBITOR; VARENICLINE; VIGABATRIN; DRUG;

EID: 79960048069     PISSN: 14741776     EISSN: 14741784     Source Type: Journal    
DOI: 10.1038/nrd3501     Document Type: Review
Times cited : (260)

References (109)
  • 1
    • 79960049967 scopus 로고    scopus 로고
    • Danish Medicines Agency Danish Medicines Agency [online]
    • Danish Medicines Agency. Conclusions and recommendations from the Pharmaceutical Forum. Danish Medicines Agency [online], http://www.dkma. dk/1024/visUKLSArtikel.asp?artikelID=17481 (2010).
    • (2010) Conclusions and Recommendations from the Pharmaceutical Forum
  • 2
    • 77953777057 scopus 로고    scopus 로고
    • EBM HTA and CER: Clearing the confusion
    • Luce, B. R. et al. EBM, HTA, and CER: clearing the confusion. Millbank Q. 88, 256-276 (2010).
    • (2010) Millbank Q , vol.88 , pp. 256-276
    • Luce, B.R.1
  • 3
    • 79960048161 scopus 로고    scopus 로고
    • European Medicines Agency recommends measures to manage contamination of heparin-containing medicines
    • European Medicines Agency
    • European Medicines Agency. European Medicines Agency recommends measures to manage contamination of heparin-containing medicines. European Medicines Agency [online], http://www.ema. europa.eu/ema/index.jsp?curl=pages/news-and- events/news/2009/11/news-detail-000315. jsp&murl=menus/news-and-events/news- and- events.jsp&mid=WC0b01ac058004d5c1&jsenabled =true (2008).
    • (2008) European Medicines Agency [Online]
  • 4
    • 79960068160 scopus 로고    scopus 로고
    • Studies assessed by the EMEA indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate
    • European Medicines Agency
    • European Medicines Agency. Studies assessed by the EMEA indicate no increased risk of developing cancer for patients who have taken Viracept contaminated with ethyl mesilate. European Medicines Agency [online]. http://www.ema.europa.eu/ema/index. jsp?curl=pages/news-and-events/news/2009/11/ news-detail-000292.jsp&murl=menus/news-and-events/news-and-events. jsp&mid=WC0b01ac058004d5c1 (2008).
    • (2008) European Medicines Agency [Online]
  • 6
    • 43249093045 scopus 로고    scopus 로고
    • More on subgroup analyses in clinical trials
    • DOI 10.1056/NEJMc0800616
    • Pocock, S. J. & Lubsen, J. More on subgroup analyses in clinical trials. N. Engl. J. Med. 358, 2076 (2008). (Pubitemid 351656480)
    • (2008) New England Journal of Medicine , vol.358 , Issue.19 , pp. 2076
    • Pocock, S.J.1    Lubsen, J.2
  • 7
    • 0035721949 scopus 로고    scopus 로고
    • Pharmacogenetics: An opportunity for a safer and more efficient pharmacotherapy
    • DOI 10.1046/j.1365-2796.2001.00879.x
    • Ingelman-Sundberg, M. Pharmacogenetics: an opportunity for a safer and more efficient pharmacotherapy. J. Intern. Med. 250, 186-200 (2001). (Pubitemid 34205685)
    • (2001) Journal of Internal Medicine , vol.250 , Issue.3 , pp. 186-200
    • Ingelman-Sundberg, M.1
  • 8
    • 53249118974 scopus 로고    scopus 로고
    • Pharmacogenetics in drug discovery and development: A translational perspective
    • Roses, A. D. Pharmacogenetics in drug discovery and development: a translational perspective. Nature Rev. Drug Discov. 7, 807-817 (2008).
    • (2008) Nature Rev. Drug Discov , vol.7 , pp. 807-817
    • Roses, A.D.1
  • 9
    • 0029942112 scopus 로고    scopus 로고
    • Cost effectiveness of lowering cholesterol concentration with statins in patients with and without pre-existing coronary heart disease: Life table method applied to health authority population
    • Pharoa, P. D. & Hollingworth, W. Cost effectiveness of lowering cholesterol concentration with statins in patients with and without pre-existing coronary heart disease: life table method applied to health authority population. BMJ 312, 1443-1448 (1996). (Pubitemid 26170615)
    • (1996) British Medical Journal , vol.312 , Issue.7044 , pp. 1443-1448
    • Pharoah, P.D.P.1    Hollingworth, W.2
  • 10
    • 2442511933 scopus 로고    scopus 로고
    • Off-label prescribing in oncology
    • DOI 10.1007/s00520-004-0593-6
    • Poole, S. G. & Dooley, M. J. Off-label prescribing in oncology. Support Care Cancer 12, 302-305 (2004). (Pubitemid 38647853)
    • (2004) Supportive Care in Cancer , vol.12 , Issue.5 , pp. 302-305
    • Poole, S.G.1    Dooley, M.J.2
  • 11
    • 52549113211 scopus 로고    scopus 로고
    • Off-label drug use among hospitalised children: Identifying areas with the highest need for research
    • Hsien, L. et al. Off-label drug use among hospitalised children: identifying areas with the highest need for research. Pharm. World Sci. 30, 497-502 (2008).
    • (2008) Pharm. World Sci , vol.30 , pp. 497-502
    • Hsien, L.1
  • 12
    • 40749161136 scopus 로고    scopus 로고
    • Guidance for off-label use of drugs
    • [No authors listed.]
    • [No authors listed.] Guidance for off-label use of drugs. Lancet Neurol. 7, 285 (2008).
    • (2008) Lancet Neurol , vol.7 , pp. 285
  • 13
    • 0036189459 scopus 로고    scopus 로고
    • Risk/benefit evaluation of drugs: The role of the pharmaceutical industry in Germany
    • Schosser, R. Risk/benefit evaluation of drugs: the role of the pharmaceutical industry in Germany. Eur. Surg. Res. 34, 203-207 (2008).
    • (2008) Eur. Surg. Res , vol.34 , pp. 203-207
    • Schosser, R.1
  • 15
    • 0037426047 scopus 로고    scopus 로고
    • How a statin might destroy a drug company
    • [No authors listed.]
    • [No authors listed.] How a statin might destroy a drug company. Lancet 361, 793 (2003).
    • (2003) Lancet , vol.361 , pp. 793
  • 16
    • 79960036000 scopus 로고    scopus 로고
    • European Medicines Agency European Medicines Agency [online]
    • European Medicines Agency. EPAR Avandia. European Medicines Agency [online], http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Assessment- Report-Variation/human/000666/WC500021280. pdf (2009).
    • (2009) EPAR Avandia
  • 17
    • 79960068337 scopus 로고    scopus 로고
    • Usage, risk and benefit of weight-loss drugs in primary care
    • Forslund, T. et al. Usage, risk and benefit of weight-loss drugs in primary care. Journal of Obesity [online], http://downloads.mts.hindawi.com/MTS- Files/JOBES/papers/regular/459263.v2.pdf?AWSAccessKeyId=0C X53QQSTHRYZZQRKA02&Expires=1305781317& Signature= hAU9a2Tn5%2BKIOsuXtCdGERM0iqA% 3D (2010).
    • (2010) Journal of Obesity [Online]
    • Forslund, T.1
  • 18
    • 79960061761 scopus 로고    scopus 로고
    • Center for Medical Technology Policy Release Date: September 14 2010 Center for Medical Technology Policy [online]
    • Center for Medical Technology Policy. Effectiveness Guidance Document: Pragmatic Phase 3 Pharmaceutical Trials. Release Date: September 14, 2010. Center for Medical Technology Policy [online], http://www.cmtpnet.org/cmtp- research/guidance-documents/pragmatic-clinical-trials/PCT3EGD.pdf (2010).
    • (2010) Effectiveness Guidance Document: Pragmatic Phase 3 Pharmaceutical Trials
  • 19
    • 77954241944 scopus 로고    scopus 로고
    • Integrating molecular diagnostics into anticancer drug discovery
    • Petak, I. et al. Integrating molecular diagnostics into anticancer drug discovery. Nature Rev. Drug Discov. 9, 523-535 (2010).
    • (2010) Nature Rev. Drug Discov , vol.9 , pp. 523-535
    • Petak, I.1
  • 20
  • 22
    • 33947712686 scopus 로고    scopus 로고
    • Stratified medicine: Strategic and economic implications of combining drugs and clinical biomarkers
    • DOI 10.1038/nrd2251, PII NRD2251
    • Trusheim, M. R. et al. Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers. Nature Rev. Drug Discov. 6, 287-293 (2007). (Pubitemid 46505879)
    • (2007) Nature Reviews Drug Discovery , vol.6 , Issue.4 , pp. 287-293
    • Trusheim, M.R.1    Berndt, E.R.2    Douglas, F.L.3
  • 23
    • 79960034156 scopus 로고    scopus 로고
    • Herceptin EPAR
    • European Medicines Agency Last updated 19 May 2011
    • European Medicines Agency. Herceptin EPAR. European Medicines Agency [online], http://www.ema. europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/000278/WC500074922.pdf (Last updated 19 May 2011).
    • European Medicines Agency [Online]
  • 24
    • 70249145878 scopus 로고    scopus 로고
    • HER2 testing and subsequent trastuzumab treatment for breast cancer in a managed care environment
    • Barron, J. J., Cziraky, M. J., Weisman, T. & Hicks, D. G. HER2 testing and subsequent trastuzumab treatment for breast cancer in a managed care environment. Oncologist 14, 760-768 (2009).
    • (2009) Oncologist , vol.14 , pp. 760-768
    • Barron, J.J.1    Cziraky, M.J.2    Weisman, T.3    Hicks, D.G.4
  • 25
    • 79960063391 scopus 로고    scopus 로고
    • EPAR Ziagen
    • European Medicines Agency Last updated 18 Apr 2011
    • European Medicines Agency. EPAR Ziagen. European Medicines Agency [online], http://www.ema.europa.eu/docs/en-GB/document-library/EPAR-Product- Information/human/000252/WC500050343.pdf (Last updated 18 Apr 2011).
    • European Medicines Agency [Online]
  • 26
    • 74349121724 scopus 로고    scopus 로고
    • Genetic polymorphism of inosine-triphosphate-pyrophosphatase influences mercaptopurine metabolism and toxicity during treatment of acute lymphoblastic leukemia individualized for thiopurine-S-methyl-transferase status
    • Stocco, G., Crews, K. R. & Evans, W. E. Genetic polymorphism of inosine-triphosphate-pyrophosphatase influences mercaptopurine metabolism and toxicity during treatment of acute lymphoblastic leukemia individualized for thiopurine-S-methyl-transferase status. Expert Opin. Drug Saf. 9, 23-37 (2010).
    • (2010) Expert Opin. Drug Saf , vol.9 , pp. 23-37
    • Stocco, G.1    Crews, K.R.2    Evans, W.E.3
  • 27
    • 74549168472 scopus 로고    scopus 로고
    • Pharmacogenomics: A new paradigm to personalize treatments in nephrology patients
    • Zaza, G., Granata, S., Sallustio, F., Grandaliano, G. & Schena, F. P. Pharmacogenomics: a new paradigm to personalize treatments in nephrology patients. Clin. Exp. Immunol.159, 268-280 (2010).
    • (2010) Clin. Exp. Immunol. , vol.159 , pp. 268-280
    • Zaza, G.1    Granata, S.2    Sallustio, F.3    Grandaliano, G.4    Schena, F.P.5
  • 28
    • 79960053602 scopus 로고    scopus 로고
    • International conference on harmonisation guideline E5(R1): Ethnic factors in the acceptability of foreign clinical data
    • ICH Expert Working Group
    • ICH Expert Working Group. International Conference on Harmonisation Guideline E5(R1): Ethnic Factors in the Acceptability of Foreign Clinical Data. ICH Harmonisation For Better Health [online], http://www. ich.org/fileadmin/ Public-Web-Site/ICH-Products/Guidelines/Efficacy/E5-R1/Step4/E5-R1-Guideline. pdf (1998).
    • (1998) ICH Harmonisation for Better Health [Online]
  • 29
    • 73949117180 scopus 로고    scopus 로고
    • Adjustment of dosing of antimicrobial agents for bodyweight in adults
    • Falagas, M. E. & Karageorgopoulos, D. E. Adjustment of dosing of antimicrobial agents for bodyweight in adults. Lancet 375, 248-251 (2010).
    • (2010) Lancet , vol.375 , pp. 248-251
    • Falagas, M.E.1    Karageorgopoulos, D.E.2
  • 30
    • 39849093340 scopus 로고    scopus 로고
    • Initial severity and antidepressant benefits: A meta-analysis of data submitted to the Food and Drug Administration
    • Kirsch, I. et al. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 5, 260-268 (2008).
    • (2008) PLoS Med , vol.5 , pp. 260-268
    • Kirsch, I.1
  • 31
    • 74049096803 scopus 로고    scopus 로고
    • A comparison of cost effectiveness using data from randomized trials or actual clinical practice: Selective Cox-2 inhibitors as an example
    • van Staa, T.-P., Leufkens, H. G., Zhang, B. & Smeeth, L. A comparison of cost effectiveness using data from randomized trials or actual clinical practice: selective Cox-2 inhibitors as an example. PLoS Med. 6, e1000194 (2009).
    • (2009) PLoS Med , vol.6
    • Van Staa, T.-P.1    Leufkens, H.G.2    Zhang, B.3    Smeeth, L.4
  • 32
    • 71449119031 scopus 로고    scopus 로고
    • Analysis of drug interactions involving fruit beverages and organic anion-transporting polypeptides
    • Greenblatt, D. J. Analysis of drug interactions involving fruit beverages and organic anion-transporting polypeptides. J. Clin. Pharmacol. 49, 1403-1407 (2009).
    • (2009) J. Clin. Pharmacol , vol.49 , pp. 1403-1407
    • Greenblatt, D.J.1
  • 33
    • 78649308647 scopus 로고    scopus 로고
    • Fruit juice inhibition of uptake transport: A new type of food-drug interaction
    • Bailey, D. G. Fruit juice inhibition of uptake transport: a new type of food-drug interaction. Br. J. Clin. Pharmacol. 70, 645-655 (2010).
    • (2010) Br. J. Clin. Pharmacol , vol.70 , pp. 645-655
    • Bailey, D.G.1
  • 34
    • 79551657212 scopus 로고    scopus 로고
    • Body mass index and clinical response to infliximab in rheumatoid arthritis
    • Klaasen, R., Wijbrandts, C. A., Gerlag, D. M. & Tak, P. P. Body mass index and clinical response to infliximab in rheumatoid arthritis. Arthritis Rheum. 63, 359-364 (2011).
    • (2011) Arthritis Rheum , vol.63 , pp. 359-364
    • Klaasen, R.1    Wijbrandts, C.A.2    Gerlag, D.M.3    Tak, P.P.4
  • 35
    • 65949098704 scopus 로고    scopus 로고
    • US Government Accountability Office: Report to the Ranking Member Committee on Finance US Senate July 2008. US Government Accountability Office [online]
    • US Government Accountability Office: Report to the Ranking Member, Committee on Finance, US Senate. Prescription drugs: FDA's oversight of the promotion of drugs for off-label uses; July 2008. US Government Accountability Office [online], http://www.gao.gov/new. items/d08835.pdf (2008).
    • (2008) Prescription Drugs: FDA's Oversight of the Promotion of Drugs for Off-label Uses
  • 36
    • 33646417326 scopus 로고    scopus 로고
    • Off-label prescribing among office-based physicians
    • Radley. D.C., Finkelstein, S.N. & Stafford, R. S. Off-label prescribing among office-based physicians. Arch. Intern. Med. 166,1021-1026 (2006).
    • (2006) Arch. Intern. Med , vol.166 , pp. 1021-1026
    • Radley, D.C.1    Finkelstein, S.N.2    Stafford, R.S.3
  • 37
    • 20044372768 scopus 로고    scopus 로고
    • Are incorrectly used drugs more frequently involved in adverse drug reactions? A prospective study
    • DOI 10.1007/s00228-004-0881-6
    • Jonville-Béra, A. P., Béra, F. & Autret-Lecaq, E. Are incorrectly used drugs more frequently involved in adverse drug reactions? A retrospective study. Eur. J. Clin. Pharmacol. 61, 231-236 (2005). (Pubitemid 40768557)
    • (2005) European Journal of Clinical Pharmacology , vol.61 , Issue.3 , pp. 231-236
    • Jonville-Bera, A.P.1    Bera, F.2    Autret-Leca, E.3
  • 38
    • 27444438492 scopus 로고    scopus 로고
    • Topiramate in non-approved indications and acute myopia or angle closure glaucoma
    • DOI 10.1111/j.1365-2125.2005.02470.x
    • Cereza, G., Pedros, C., Garcia, N. & Laporte, J. R. Topiramate in non-approved indications and acute myopia or angle-closure glaucoma. Br. J. Clin. Pharmacol. 60, 578-579 (2005). (Pubitemid 41532461)
    • (2005) British Journal of Clinical Pharmacology , vol.60 , Issue.5 , pp. 578-579
    • Cereza, G.1    Pedros, C.2    Garcia, N.3    Laporte, J.-R.4
  • 40
    • 0141974835 scopus 로고    scopus 로고
    • Perspectives from the pharmaceutical industry
    • Bonaccorso, S. & Sturchio, J. L. Perspectives from the pharmaceutical industry. BMJ 327, 863-864 (2003). (Pubitemid 37271706)
    • (2003) British Medical Journal , vol.327 , Issue.7419 , pp. 863-864
    • Bonaccorso, S.1    Sturchio, J.L.2
  • 41
    • 79960071020 scopus 로고    scopus 로고
    • Adherence to long-term therapies: Evidence for action
    • WHO.
    • WHO. Adherence to long-term therapies: evidence for action. World Health Organization [online], http://apps.who.int/medicinedocs/en/d/Js4883e/(2003).
    • (2003) World Health Organization [Online]
  • 42
    • 0036040466 scopus 로고    scopus 로고
    • The odds of the three nons when an aptly prescribed medicine isn't working: Non-compliance, non-absorption, non-response
    • DOI 10.1046/j.1365-2125.2002.01629.x
    • Urquhart, J. The odds of the three nons when an aptly prescribed medicine isn't working: non-compliance, non-absorption, non-response. Br. J. Clin. Pharmacol. 54, 212-220 (2002). (Pubitemid 35024946)
    • (2002) British Journal of Clinical Pharmacology , vol.54 , Issue.2 , pp. 212-220
    • Urquhart, J.1
  • 44
    • 37349082807 scopus 로고    scopus 로고
    • The significance of compliance and persistence in the treatment of diabetes, hypertension and dyslipidaemia: A review
    • DOI 10.1111/j.1742-1241.2007.01630.x
    • Cramer, J. A, Benedict, Á, Muszbek, N., Keskinaslan, A. & Khan, Z. M. The significance of compliance and persistence in the treatment of diabetes, hypertension and dyslipidaemia: a review. Int. J. Clin. Pract. 62, 76-87 (2008). (Pubitemid 350294021)
    • (2008) International Journal of Clinical Practice , vol.62 , Issue.1 , pp. 76-87
    • Cramer, J.A.1    Benedict, A.2    Muszbek, N.3    Keskinaslan, A.4    Khan, Z.M.5
  • 45
    • 15244355334 scopus 로고    scopus 로고
    • The odds that clinically unrecognized poor or partial adherence confuses population pharmacokinetic/pharmacodynamic analyses
    • DOI 10.1111/j.1742-7843.2005.pto960312.x
    • Vrijens, B., Gross, R. & Urquhart, J. The odds that clinically unrecognised poor or partial adherence confuses population pharmacokinetic/ pharmacodynamic analyses. Basic Clin. Pharmacol. Toxicol. 96, 225-227 (2005). (Pubitemid 40387999)
    • (2005) Basic and Clinical Pharmacology and Toxicology , vol.96 , Issue.3 , pp. 225-227
    • Vrijens, B.1    Gross, R.2    Urquhart, J.3
  • 46
    • 84889843112 scopus 로고    scopus 로고
    • Getting a handle on why good drugs sometimes don't work
    • Urquhart, J. Getting a handle on why good drugs sometimes don't work. J. R. Coll. Physicians Edinb. 34, 95-98 (2004).
    • (2004) J. R. Coll. Physicians Edinb , vol.34 , pp. 95-98
    • Urquhart, J.1
  • 47
    • 0000710874 scopus 로고    scopus 로고
    • Achievements in public health, 1900-1999 family planning
    • Centers for Disease Control and Prevention
    • Centers for Disease Control and Prevention. Achievements in Public Health, 1900-1999 Family Planning. MMWR Morb. Mortal. Wkly. Rep. 48, 1073-1080 (1999).
    • (1999) MMWR Morb. Mortal. Wkly. Rep , vol.48 , pp. 1073-1080
  • 49
    • 18844421818 scopus 로고    scopus 로고
    • Patient adherence to prescribed antimicrobial drug dosing regimens
    • DOI 10.1093/jac/dki066
    • Vrijens, B. & Urquhart, J. Patient adherence to prescribed antimicrobial drug dosing regimens. J. Antimicrob. Chemother. 55, 616-627 (2005). (Pubitemid 40691838)
    • (2005) Journal of Antimicrobial Chemotherapy , vol.55 , Issue.5 , pp. 616-627
    • Vrijens, B.1    Urquhart, J.2
  • 50
    • 79960036864 scopus 로고    scopus 로고
    • Factors affecting the effectiveness of clinical decisions in treating schizophrenia
    • 17-22 May San Francisco, California, USA; Abstract S28C
    • Olfson, M., West, J. C., Wilk, J. E. & Marcus, S. Factors affecting the effectiveness of clinical decisions in treating schizophrenia. in Proc. of the American Psychiatric Assoc. 156th Annual Meeting (17-22 May 2003; San Francisco, California, USA; Abstract S28C).
    • (2003) Proc. of the American Psychiatric Assoc. 156th Annual Meeting
    • Olfson, M.1    West, J.C.2    Wilk, J.E.3    Marcus, S.4
  • 51
    • 44349111871 scopus 로고    scopus 로고
    • Adherence to prescribed antihypertensive drug treatments: Longitudinal study of electronically compiled dosing histories
    • DOI 10.1136/bmj.39553.670231.25
    • Vrijens, B., Vincze, G., Kristanto, P., Urquhart, J. & Burnier, M. Adherence to prescribed antihypertensive drug treatments: longitudinal study of electronically compiled dosing histories. BMJ 336, 1114-1117 (2008). (Pubitemid 351731741)
    • (2008) BMJ , vol.336 , Issue.7653 , pp. 1114-1117
    • Vrijens, B.1    Vincze, G.2    Kristanto, P.3    Urquhart, J.4    Burnier, M.5
  • 52
    • 77952521444 scopus 로고    scopus 로고
    • Effect of concomitant CYP2D6 inhibitor use and tamoxifen adherence on breast cancer recurrence in early-stage breast cancer
    • Vincent, O. et al. Effect of concomitant CYP2D6 inhibitor use and tamoxifen adherence on breast cancer recurrence in early-stage breast cancer. J. Clin. Oncol. 28, 2423-2429 (2010).
    • (2010) J. Clin. Oncol , vol.28 , pp. 2423-2429
    • Vincent, O.1
  • 53
    • 78650794601 scopus 로고    scopus 로고
    • Patients with early rheumatoid arthritis who smoke are less likely to respond to treatment with methotrexate and tumor necrosis factor inhibitors
    • Saevarsdottir, S. et al. Patients with early rheumatoid arthritis who smoke are less likely to respond to treatment with methotrexate and tumor necrosis factor inhibitors. Arthtitis Rheum. 63. 26-36 (2011).
    • (2011) Arthtitis Rheum , vol.63 , pp. 26-36
    • Saevarsdottir, S.1
  • 54
    • 0025735163 scopus 로고
    • Chronobiology: Suggestions for integrating it into drug development
    • Harter, J. G. & Peck, C. C. Chronobiology: suggestions for integrating it into drug development. Ann. N. Y. Acad. Sci. 618, 563-571 (1991).
    • (1991) Ann. N. Y. Acad. Sci , vol.618 , pp. 563-571
    • Harter, J.G.1    Peck, C.C.2
  • 55
    • 34247530125 scopus 로고    scopus 로고
    • Factors that can affect the external validity of randomised controlled trials
    • Rothwell, P. M. Factors that can affect the external validity of randomised controlled trials. PLoS Clin. Trials 1, e9 (2006).
    • (2006) PLoS Clin. Trials , vol.1
    • Rothwell, P.M.1
  • 56
    • 65649135904 scopus 로고    scopus 로고
    • A pragmatic-explanatory continuum indicator summary (PRECIS): A tool to help trial designers
    • Thorpe, K. E. et al. A pragmatic-explanatory continuum indicator summary (PRECIS): a tool to help trial designers. CMAJ 180, e47-e57 (2009).
    • (2009) CMAJ , vol.180
    • Thorpe, K.E.1
  • 57
    • 78449283356 scopus 로고    scopus 로고
    • Enrichment of clinical study populations
    • Temple, R. Enrichment of clinical study populations. Clin. Pharmacol. Ther. 88, 774-778 (2010).
    • (2010) Clin. Pharmacol. Ther , vol.88 , pp. 774-778
    • Temple, R.1
  • 58
    • 79960060832 scopus 로고    scopus 로고
    • Why medicare pays so much for cancer drugs. European medicines agency
    • Goldstein, J. Why Medicare Pays so Much For Cancer Drugs. European Medicines Agency. Wall Street Journal [online], http://blogs.wsj.com/health/ 2009/01/27/why-medicare-pays-so-much-for-ca ncer-drugs/tab/comments/(2009).
    • (2009) Wall Street Journal [Online]
    • Goldstein, J.1
  • 59
    • 33846982983 scopus 로고    scopus 로고
    • Regulatory policies on medicines for psychiatric disorders: Is Europe on target?
    • Barbui, C. & Garattini, S. Regulatory policies on medicines for psychiatric disorders: is Europe on target? Br. J. Psychiatry 190, 91-93 (2007).
    • (2007) Br. J. Psychiatry , vol.190 , pp. 91-93
    • Barbui, C.1    Garattini, S.2
  • 60
    • 12344307477 scopus 로고    scopus 로고
    • A new system for moving drugs to market
    • Woosley, R. L. & Rice, G. A new system for moving drugs to market. Issues Sci. Technol. XXI, 63-68 (2005). (Pubitemid 40135172)
    • (2005) Issues in Science and Technology , vol.21 , Issue.2 , pp. 63-68
    • Woosley, R.L.1    Rice, G.2
  • 61
    • 53249132632 scopus 로고    scopus 로고
    • Balancing early market access to new drugs with the need for benefit/risk data: A mounting dilemma
    • Eichler, H. G., Pignatti, F., Flamion, B., Leufkens, H. & Breckenridge, A. Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nature Rev. Drug Discov. 7, 818-826 (2008).
    • (2008) Nature Rev. Drug Discov , vol.7 , pp. 818-826
    • Eichler, H.G.1    Pignatti, F.2    Flamion, B.3    Leufkens, H.4    Breckenridge, A.5
  • 62
  • 63
    • 83155182428 scopus 로고    scopus 로고
    • E-SPC - Delivering drug information in the 21st century: Developing new approaches to deliver drug information to prescribers
    • on behalf of the e-SPC consortium 6 Apr doi:10.1111/j.1365-21252011. 03981.x
    • Maxwell, S., Eichler, H. G., Bucsics, A., Haefeli, W. E. & Gustafsson, L.L. on behalf of the e-SPC consortium. e-SPC - delivering drug information in the 21st century: developing new approaches to deliver drug information to prescribers. Br. J. Clin. Pharmacol. 6 Apr 2011 (doi:10.1111/j.1365-21252011.03981.x.).
    • (2011) Br. J. Clin. Pharmacol.
    • Maxwell, S.1    Eichler, H.G.2    Bucsics, A.3    Haefeli, W.E.4    Gustafsson, L.L.5
  • 64
    • 0029877017 scopus 로고    scopus 로고
    • Patient non-compliance with drug regimens: Measurement, clinical correlates, economic impact
    • Urquhart, J. Patient noncompliance with drug regimens: measurement, clinical correlates, economic impact. Eur. Heart J. 17 (Suppl. A), 8-15 (1996). (Pubitemid 26129713)
    • (1996) European Heart Journal , vol.17 , Issue.SUPPL. A , pp. 8-15
    • Urquhart, J.1
  • 66
    • 0030972456 scopus 로고    scopus 로고
    • Using numerical results from systematic reviews in clinical practice
    • McQuay, H. J. & Moore, R. A. Using numerical results from systematic reviews in clinical practice. Ann. Intern. Med. 126, 712-720 (1997). (Pubitemid 27184043)
    • (1997) Annals of Internal Medicine , vol.126 , Issue.9 , pp. 712-720
    • McQuay, H.J.1    Moore, R.A.2
  • 67
    • 78449294101 scopus 로고    scopus 로고
    • Assessing the clinical utility of diagnostics used in drug therapy
    • Woodcock J. Assessing the clinical utility of diagnostics used in drug therapy. Clin. Pharmacol. Ther. 88, 765-773 (2010).
    • (2010) Clin. Pharmacol. Ther , vol.88 , pp. 765-773
    • Woodcock, J.1
  • 68
    • 69949162760 scopus 로고    scopus 로고
    • Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma
    • Mok, T. S. et al. Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N. Engl. J. Med. 361, 947-957 (2009).
    • (2009) N. Engl. J. Med , vol.361 , pp. 947-957
    • Mok, T.S.1
  • 69
    • 57149124098 scopus 로고    scopus 로고
    • A paucimorphic variant in the HMG-CoA reductase gene is associated with lipid-lowering response to statin treatment in diabetes: A GoDARTS study
    • Donnelly, L. A. et al. A paucimorphic variant in the HMG-CoA reductase gene is associated with lipid-lowering response to statin treatment in diabetes: a GoDARTS study. Pharmacogenet. Genomics 18, 1021-1026 (2008).
    • (2008) Pharmacogenet. Genomics , vol.18 , pp. 1021-1026
    • Donnelly, L.A.1
  • 70
    • 39449137238 scopus 로고    scopus 로고
    • Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin
    • DOI 10.1097/GIM.0b013e318163c35f, PII 0012581720080200000010
    • Flockhart, D. A. Pharmacogenetic testing of CYP2C9 and VKORC1 alleles for warfarin. Genet. Med. 10, 139-150 (2008). (Pubitemid 351271726)
    • (2008) Genetics in Medicine , vol.10 , Issue.2 , pp. 139-150
    • Flockhart, D.A.1    O'Kane, D.2    Williams, M.S.3    Watson, M.S.4
  • 71
    • 77953308585 scopus 로고    scopus 로고
    • The long and winding road to warfarin pharmacogenetic testing
    • Ginsburg, G. S. & Voora, D. The long and winding road to warfarin pharmacogenetic testing. J. Am. Coll. Cardiol. 55, 2813-2815 (2010).
    • (2010) J. Am. Coll. Cardiol , vol.55 , pp. 2813-2815
    • Ginsburg, G.S.1    Voora, D.2
  • 72
    • 77951898626 scopus 로고    scopus 로고
    • Pharmacogenetics of warfarin
    • Kamali, F. & Wynne, H. Pharmacogenetics of warfarin. Annu. Rev. Med. 61, 63-75 (2010).
    • (2010) Annu. Rev. Med , vol.61 , pp. 63-75
    • Kamali, F.1    Wynne, H.2
  • 73
    • 77951778977 scopus 로고    scopus 로고
    • Personalised medicine in oncology
    • Schilsky, R. L. Personalised medicine in oncology. Nature Rev. Drug Discov. 9, 363-366 (2010).
    • (2010) Nature Rev. Drug Discov , vol.9 , pp. 363-366
    • Schilsky, R.L.1
  • 74
    • 53249118974 scopus 로고    scopus 로고
    • Pharmacogenetics in drug discovery and development: A translational perspective
    • Roses, A. D. Pharmacogenetics in drug discovery and development: a translational perspective. Nature Rev. Drug Discov. 7, 807-817 (2008).
    • (2008) Nature Rev. Drug Discov , vol.7 , pp. 807-817
    • Roses, A.D.1
  • 75
    • 79960059456 scopus 로고    scopus 로고
    • Reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development
    • European Medicines Agency
    • European Medicines Agency. Reflection paper on co-development of pharmacogenomic biomarkers and assays in the context of drug development. European Medicines Agency [online], http://www.ema.europa.eu/docs/en-GB/ document-library/Scientific-guideline/2010/07/WC500094445.pdf (2010).
    • (2010) European Medicines Agency [Online]
  • 76
    • 79960038685 scopus 로고    scopus 로고
    • International Pharmaceutical Regulatory Monitor: US FDA draft guidance explains new drug development tools
    • FDA
    • FDA. International Pharmaceutical Regulatory Monitor: US FDA draft guidance explains new drug development tools. FDA News [online], http://www. fdanews.com/newsletter/article?issueId=14226&artic leId=131972 (2010).
    • (2010) FDA News [Online]
  • 77
    • 79960041484 scopus 로고    scopus 로고
    • Qualification of novel methodologies for drug development: Guidance to applicants
    • European Medicines Agency
    • European Medicines Agency. Qualification of novel methodologies for drug development: guidance to applicants. European Medicines Agency [online], http://www.ema.europa.eu/docs/en-GB/document-library/Regulatory-and-procedural- guideline/2009/10/WC500004201.pdf (2009).
    • (2009) European Medicines Agency [Online]
  • 78
    • 79551609869 scopus 로고    scopus 로고
    • An accelerated pathway for targeted cancer therapies
    • McClellan, M. et al. An accelerated pathway for targeted cancer therapies. Nature Rev. Drug Discov. 10, 79-80 (2011).
    • (2011) Nature Rev. Drug Discov , vol.10 , pp. 79-80
    • McClellan, M.1
  • 79
    • 69949158158 scopus 로고    scopus 로고
    • Rethinking therapeutic cancer vaccines
    • [No authors listed.]
    • [No authors listed.] Rethinking therapeutic cancer vaccines. Nature Rev. Drug Discov. 8, 685-686 (2009).
    • (2009) Nature Rev. Drug Discov , vol.8 , pp. 685-686
  • 80
    • 82755161905 scopus 로고    scopus 로고
    • Biomarkers for Alzheimer's disease therapeutic trials
    • 2 Dec doi:10.1016/j.pneurobio.2010.11.005
    • Hampel, H. et al. Biomarkers for Alzheimer's disease therapeutic trials. Prog. Neurobiol. 2 Dec 2010 (doi:10.1016/j.pneurobio.2010.11.005).
    • (2010) Prog. Neurobiol.
    • Hampel, H.1
  • 81
    • 77949892852 scopus 로고    scopus 로고
    • Relative effectiveness assessment of listed drugs (REAL): A new method for an early comparison of the effectiveness of approved health technologies
    • Falissard, B. et al. Relative effectiveness assessment of listed drugs (REAL): a new method for an early comparison of the effectiveness of approved health technologies. Int. J. Technol. Assess Health Care 26, 124-130 (2010).
    • (2010) Int. J. Technol. Assess Health Care , vol.26 , pp. 124-130
    • Falissard, B.1
  • 82
    • 77953866148 scopus 로고    scopus 로고
    • Clinical pharmacology in research, teaching and health care: Considerations by IUPHAR, the Inter-national Union of Basic and Clinical Pharmacology
    • Birkett, D. et al. Clinical pharmacology in research, teaching and health care: considerations by IUPHAR, the Inter-national Union of Basic and Clinical Pharmacology. Basic Clin. Pharmacol. Toxicol. 107, 531-559 (2010).
    • (2010) Basic Clin. Pharmacol. Toxicol , vol.107 , pp. 531-559
    • Birkett, D.1
  • 83
    • 0037108235 scopus 로고    scopus 로고
    • Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: Current practice and problems
    • Pocock, S. J., Assmann, S. E., Enos, L. E. & Kasten, L. E. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat. Med. 21, 2917-2930 (2002).
    • (2002) Stat. Med , vol.21 , pp. 2917-2930
    • Pocock, S.J.1    Assmann, S.E.2    Enos, L.E.3    Kasten, L.E.4
  • 85
    • 70449105165 scopus 로고    scopus 로고
    • Proposals for model-based paediatric medicinal development within the current European Union regulatory framework
    • Manolis, E. & Pons, G. Proposals for model-based paediatric medicinal development within the current European Union regulatory framework. Br. J. Clin. Pharmacol. 68, 493-501 (2009).
    • (2009) Br. J. Clin. Pharmacol , vol.68 , pp. 493-501
    • Manolis, E.1    Pons, G.2
  • 86
    • 71649115884 scopus 로고    scopus 로고
    • How to reduce prescribing errors
    • [No authors listed.]
    • [No authors listed.] How to reduce prescribing errors. Lancet 374, 1945 (2009).
    • (2009) Lancet , vol.374 , pp. 1945
  • 87
    • 79960065371 scopus 로고    scopus 로고
    • Evidence-based Practice Centres: Synthesizing scientific evidence to improve quality and effectiveness in health care
    • [No authors listed.]
    • [No authors listed.] Evidence-based Practice Centres: synthesizing scientific evidence to improve quality and effectiveness in health care. Agency for Healthcare Research and Quality [online], http://www.ahrq.gov/clinic/epc/ (2011).
    • (2011) Agency for Healthcare Research and Quality [Online]
  • 88
    • 78549255598 scopus 로고    scopus 로고
    • Public pharmacovigilance communication: A process calling for evidence-based, objective-driven strategies
    • Bahri, P. Public pharmacovigilance communication: a process calling for evidence-based, objective-driven strategies. Drug Saf. 33,1065-1079 (2010).
    • (2010) Drug Saf , vol.33 , pp. 1065-1079
    • Bahri, P.1
  • 90
    • 70249145878 scopus 로고    scopus 로고
    • HER2 testing and subsequent trastuzumab treatment for breast cancer in a managed care environment
    • John, J. et al. HER2 testing and subsequent trastuzumab treatment for breast cancer in a managed care environment. Oncologist 14, 760-768 (2009).
    • (2009) Oncologist , vol.14 , pp. 760-768
    • John, J.1
  • 91
    • 79952776749 scopus 로고    scopus 로고
    • The "wise List" - A comprehensive concept to select, communicate and achieve recommendations of essential drugs in ambulatory care in Stockholm
    • Gustafsson, L. L. et al. The "Wise List" - a comprehensive concept to select, communicate and achieve recommendations of essential drugs in ambulatory care in Stockholm. Basic Clin. Pharmacol. Toxicol.108, 224-233 (2011).
    • (2011) Basic Clin. Pharmacol. Toxicol. , vol.108 , pp. 224-233
    • Gustafsson, L.L.1
  • 92
    • 74849087466 scopus 로고    scopus 로고
    • Accelerating the use of electronic health records in physician practices
    • Shea, S. & Hripcsak, G. Accelerating the use of electronic health records in physician practices. N. Engl. J. Med. 362, 192-195 (2010).
    • (2010) N. Engl. J. Med , vol.362 , pp. 192-195
    • Shea, S.1    Hripcsak, G.2
  • 95
    • 68849122305 scopus 로고    scopus 로고
    • SFINX - A drug-drug interaction database desgined for clinical decision support systems
    • Böttiger, Y. et al. SFINX - a drug-drug interaction database desgined for clinical decision support systems. Eur. J. Clin. Pharmacol. 95, 627-633 (2009).
    • (2009) Eur. J. Clin. Pharmacol , vol.95 , pp. 627-633
    • Böttiger, Y.1
  • 97
    • 77951706928 scopus 로고    scopus 로고
    • Thinking outside the pillbox - Medication adherence as a priority for health care reform
    • Cutler, D. & Everett, W. Thinking outside the pillbox - medication adherence as a priority for health care reform. N. Engl. J. Med. 362, 1553-1555 (2010).
    • (2010) N. Engl. J. Med , vol.362 , pp. 1553-1555
    • Cutler, D.1    Everett, W.2
  • 98
    • 33746007043 scopus 로고    scopus 로고
    • Barriers to treatment adherence for children with cystic fibrosis and asthma: What gets in the way?
    • DOI 10.1093/jpepsy/jsj096
    • Modi, A. C. & Quittner, A. L. Barriers to treatment adherence for children with cystic fibrosis and asthma: what gets in the way? J. Pediatr. Psychol. 31, 846-858 (2006). (Pubitemid 44310212)
    • (2006) Journal of Pediatric Psychology , vol.31 , Issue.8 , pp. 846-858
    • Modi, A.C.1    Quittner, A.L.2
  • 99
    • 77957059510 scopus 로고    scopus 로고
    • Understanding forgiveness: Minding and mining the gaps between pharmacokinetics and therapeutics
    • Osterberg, L. G., Urquhart, J. & Blaschke, T. F. Understanding forgiveness: minding and mining the gaps between pharmacokinetics and therapeutics. Clin. Pharmacol. Ther. 88, 457-459 (2010).
    • (2010) Clin. Pharmacol. Ther , vol.88 , pp. 457-459
    • Osterberg, L.G.1    Urquhart, J.2    Blaschke, T.F.3
  • 101
    • 78649456108 scopus 로고    scopus 로고
    • Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): A randomised trial
    • Lester, R. T. et al. Effects of a mobile phone short message service on antiretroviral treatment adherence in Kenya (WelTel Kenya1): a randomised trial. Lancet 376, 1838-1845 (2010).
    • (2010) Lancet , vol.376 , pp. 1838-1845
    • Lester, R.T.1
  • 102
    • 78649490371 scopus 로고    scopus 로고
    • Mobile phones to improve HIV treatment adherence
    • Chi, B. H. & Stringer, J. S. A. Mobile phones to improve HIV treatment adherence. Lancet 376, 1807-1808 (2010).
    • (2010) Lancet , vol.376 , pp. 1807-1808
    • Chi, B.H.1    Stringer, J.S.A.2
  • 103
    • 77955054268 scopus 로고    scopus 로고
    • Self-titration for treatment of uncomplicated hypertension
    • Ogedegbe G. Self-titration for treatment of uncomplicated hypertension. Lancet 376, 144-146 (2010).
    • (2010) Lancet , vol.376 , pp. 144-146
    • Ogedegbe, G.1
  • 105
    • 79960071964 scopus 로고    scopus 로고
    • A networked system for self-management of drug therapy and wellness
    • Au-Yeung, K. Y. et al. A networked system for self-management of drug therapy and wellness. ACM Digital Library [online], http://delivery.acm. org/10.1145/1930000/1921083/p1-au-yeung.pdf?ke y1=1921083&key2= 9929465921&coll=DL&dl= ACM&CFID=7014173&CFTOKEN=96965669 (2010).
    • (2010) ACM Digital Library [Online]
    • Au-Yeung, K.Y.1
  • 106
    • 20544460816 scopus 로고    scopus 로고
    • Impact of medication adherence on hospitalization risk and healthcare cost
    • DOI 10.1097/01.mlr.0000163641.86870.af
    • Sokol, M. C., McGuigan, K. A., Verbrugge, R. R. & Epstein, R. S. Impact of medication adherence on hospitalization risk and healthcare cost. Med. Care 43, 521-530 (2005). (Pubitemid 40847288)
    • (2005) Medical Care , vol.43 , Issue.6 , pp. 521-530
    • Sokol, M.C.1    McGuigan, K.A.2    Verbrugge, R.R.3    Epstein, R.S.4
  • 107
    • 79955736485 scopus 로고    scopus 로고
    • Pragmatic trials - Guide to better patient care? N
    • Ware, J. H. & Hamel, M. B. Pragmatic trials - guide to better patient care? N. Engl. J. Med. 364, 1685-1687 (2011).
    • (2011) Engl. J. Med , vol.364 , pp. 1685-1687
    • Ware, J.H.1    Hamel, M.B.2
  • 108
    • 75949085017 scopus 로고    scopus 로고
    • 2009 FDA drug approvals
    • Hughes, B. 2009 FDA drug approvals. Nature Rev. Drug Discov. 9, 89-92 (2010).
    • (2010) Nature Rev. Drug Discov , vol.9 , pp. 89-92
    • Hughes, B.1


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