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Volumn 10, Issue 3, 2013, Pages

Number of Patients Studied Prior to Approval of New Medicines: A Database Analysis

Author keywords

[No Author keywords available]

Indexed keywords

ANALGESIC AGENT; ANTIINFECTIVE AGENT; ANTINEOPLASTIC AGENT; ORPHAN DRUG;

EID: 84875425022     PISSN: 15491277     EISSN: 15491676     Source Type: Journal    
DOI: 10.1371/journal.pmed.1001407     Document Type: Review
Times cited : (71)

References (40)
  • 1
    • 3042806975 scopus 로고    scopus 로고
    • Detection, verification, and quantification of adverse drug reactions
    • Stricker BH, Psaty BM, (2004) Detection, verification, and quantification of adverse drug reactions. BMJ 329: 44-47.
    • (2004) BMJ , vol.329 , pp. 44-47
    • Stricker, B.H.1    Psaty, B.M.2
  • 2
    • 80053339519 scopus 로고    scopus 로고
    • Why drug safety should not take a back seat to efficacy
    • doi:10.1371/journal.pmed.1001097
    • Barbour V, Clark J, Jones S, Norton M, Simpson P, et al. (2011) Why drug safety should not take a back seat to efficacy. PLoS Med 8: e1001097 doi:10.1371/journal.pmed.1001097.
    • (2011) PLoS Med , vol.8
    • Barbour, V.1    Clark, J.2    Jones, S.3    Norton, M.4    Simpson, P.5
  • 3
    • 57049133083 scopus 로고    scopus 로고
    • Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects
    • Vandenbroucke JP, Psaty BM, (2008) Benefits and risks of drug treatments: how to combine the best evidence on benefits with the best data about adverse effects. JAMA 300: 2417-2419.
    • (2008) JAMA , vol.300 , pp. 2417-2419
    • Vandenbroucke, J.P.1    Psaty, B.M.2
  • 4
    • 84875417483 scopus 로고
    • Committee for Proprietary Medicinal Products, CPMP/ICH/375/95, Accessed 8 February 2013
    • Committee for Proprietary Medicinal Products (1994) ICH topic E 1-population exposure: the extent of population exposure to assess clinical safety. CPMP/ICH/375/95. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002747.pdf. Accessed 8 February 2013.
    • (1994) ICH topic E 1-population exposure: The extent of population exposure to assess clinical safety
  • 6
    • 84968762251 scopus 로고    scopus 로고
    • European Commission Directorate-General Health and Consumers, Accessed 4 February 2013
    • European Commission Directorate-General Health and Consumers (2013) Community register of medicinal products. Available: http://ec.europa.eu/health/documents/community-register/html/index_en.htm. Accessed 4 February 2013.
    • (2013) Community register of medicinal products
  • 7
    • 0008348082 scopus 로고    scopus 로고
    • European Medicines Agency, Accessed 4 February 2013
    • European Medicines Agency (2013) European public assessment reports. Available: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125. Accessed 4 February 2013.
    • (2013) European public assessment reports
  • 8
    • 0026062031 scopus 로고
    • Study of United Kingdom product licence applications containing new active substances, 1987-9
    • Rawlins MD, Jefferys DB, (1991) Study of United Kingdom product licence applications containing new active substances, 1987-9. BMJ 302: 223-225.
    • (1991) BMJ , vol.302 , pp. 223-225
    • Rawlins, M.D.1    Jefferys, D.B.2
  • 9
    • 34250212715 scopus 로고    scopus 로고
    • Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes
    • Nissen SE, Wolski K, (2007) Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med 356: 2457-2471.
    • (2007) N Engl J Med , vol.356 , pp. 2457-2471
    • Nissen, S.E.1    Wolski, K.2
  • 10
    • 77957952617 scopus 로고    scopus 로고
    • Regulatory action on rosiglitazone by the U.S. Food and Drug Administration
    • Woodcock J, Sharfstein JM, Hamburg M, (2010) Regulatory action on rosiglitazone by the U.S. Food and Drug Administration. N Engl J Med 363: 1489-1491.
    • (2010) N Engl J Med , vol.363 , pp. 1489-1491
    • Woodcock, J.1    Sharfstein, J.M.2    Hamburg, M.3
  • 11
    • 53249132632 scopus 로고    scopus 로고
    • Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma
    • Eichler HG, Pignatti F, Flamion B, Leufkens H, Breckenridge A, (2008) Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma. Nat Rev Drug Discov 7: 818-826.
    • (2008) Nat Rev Drug Discov , vol.7 , pp. 818-826
    • Eichler, H.G.1    Pignatti, F.2    Flamion, B.3    Leufkens, H.4    Breckenridge, A.5
  • 16
    • 33646818280 scopus 로고    scopus 로고
    • Evaluating drug effects in the post-Vioxx world: there must be a better way
    • Avorn J, (2006) Evaluating drug effects in the post-Vioxx world: there must be a better way. Circulation 113: 2173-2176.
    • (2006) Circulation , vol.113 , pp. 2173-2176
    • Avorn, J.1
  • 17
    • 0033518849 scopus 로고    scopus 로고
    • Postmarketing surveillance and adverse drug reactions: current perspectives and future needs
    • Brewer T, Colditz GA, Brewer T, (1999) Postmarketing surveillance and adverse drug reactions: current perspectives and future needs. JAMA 281: 824-829.
    • (1999) JAMA , vol.281 , pp. 824-829
    • Brewer, T.1    Colditz, G.A.2    Brewer, T.3
  • 18
    • 34548076313 scopus 로고    scopus 로고
    • Gold standards in pharmacovigilance-the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore
    • Hauben M, Aronson JK, (2007) Gold standards in pharmacovigilance-the use of definitive anecdotal reports of adverse drug reactions as pure gold and high-grade ore. Drug Saf 30: 645-655.
    • (2007) Drug Saf , vol.30 , pp. 645-655
    • Hauben, M.1    Aronson, J.K.2
  • 19
    • 0037275431 scopus 로고    scopus 로고
    • A model for the future conduct of pharmacovigilance
    • Waller PC, Evans SJ, (2003) A model for the future conduct of pharmacovigilance. Pharmacoepidemiol Drug Saf 12: 17-29.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , pp. 17-29
    • Waller, P.C.1    Evans, S.J.2
  • 20
    • 84875449832 scopus 로고    scopus 로고
    • Mini-Sentinel Coordinating Center, Accessed 4 February 2013
    • Mini-Sentinel Coordinating Center (2011) Welcome to Mini-Sentinel. Available: http://www.mini-sentinel.org/. Accessed 4 February 2013.
    • (2011) Welcome to Mini-Sentinel
  • 21
    • 78149349684 scopus 로고    scopus 로고
    • US Food and Drug Administration, Accessed 4 February 2013
    • US Food and Drug Administration (2013) FDA's Sentinel Initiative. Available: http://www.fda.gov/Safety/FDAsSentinelInitiative/default.htm. Accessed 4 February 2013.
    • (2013) FDA's Sentinel Initiative
  • 22
    • 84875438414 scopus 로고    scopus 로고
    • EU-ADR, Accessed 4 February 2013
    • EU-ADR (2013) Welcome to the EU-ADR website. Available: http://www.alert-project.org/. Accessed 4 February 2013.
    • (2013) Welcome to the EU-ADR website
  • 23
    • 68849123390 scopus 로고    scopus 로고
    • Managing drug-risk information-what to do with all those new numbers
    • Avorn J, Schneeweiss S, (2009) Managing drug-risk information-what to do with all those new numbers. N Engl J Med 361: 647-649.
    • (2009) N Engl J Med , vol.361 , pp. 647-649
    • Avorn, J.1    Schneeweiss, S.2
  • 24
    • 79851472033 scopus 로고    scopus 로고
    • Developing the Sentinel System-a national resource for evidence development
    • Behrman RE, Benner JS, Brown JS, McClellan M, Woodcock J, et al. (2011) Developing the Sentinel System-a national resource for evidence development. N Engl J Med 364: 498-499.
    • (2011) N Engl J Med , vol.364 , pp. 498-499
    • Behrman, R.E.1    Benner, J.S.2    Brown, J.S.3    McClellan, M.4    Woodcock, J.5
  • 25
    • 78650362198 scopus 로고    scopus 로고
    • Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project
    • Coloma PM, Schuemie MJ, Trifirò G, Gini R, Herings R, et al. (2010) Combining electronic healthcare databases in Europe to allow for large-scale drug safety monitoring: the EU-ADR Project. Pharmacoepidemiol Drug Saf 20: 1-11.
    • (2010) Pharmacoepidemiol Drug Saf , vol.20 , pp. 1-11
    • Coloma, P.M.1    Schuemie, M.J.2    Trifirò, G.3    Gini, R.4    Herings, R.5
  • 28
    • 84875421746 scopus 로고    scopus 로고
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Accessed 8 February 2013
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (2002) ICH harmonised tripartite guideline: Pharmacovigilance Planning-E2E. Available: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E2E/Step4/E2E_Guideline.pdf. Accessed 8 February 2013.
    • (2002) ICH harmonised tripartite guideline: Pharmacovigilance Planning-E2E
  • 30
    • 84872716330 scopus 로고    scopus 로고
    • Heads of Medicines Agencies, European Medicines Agency, EMA/838713/2011, Accessed 11 February 2013
    • Heads of Medicines Agencies, European Medicines Agency (2012) Guideline on good pharmacovigilance practices (GVP): module V-risk management systems. EMA/838713/2011. Available: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf. Accessed 11 February 2013.
    • (2012) Guideline on good pharmacovigilance practices (GVP): Module V-risk management systems
  • 32
    • 84873612237 scopus 로고    scopus 로고
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, Accessed 11 February 2013
    • US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research (2011) Guidance for industry: postmarketing studies and clinical trials-implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. Available: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf. Accessed 11 February 2013.
    • (2011) Guidance for industry: Postmarketing studies and clinical trials-implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act
  • 35
    • 80053277574 scopus 로고    scopus 로고
    • European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance
    • Blake KV, Prilla S, Accadebled S, Guimier M, Biscaro M, et al. (2011) European Medicines Agency review of post-authorisation studies with implications for the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Pharmacoepidemiol Drug Saf 20: 1021-1029.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , pp. 1021-1029
    • Blake, K.V.1    Prilla, S.2    Accadebled, S.3    Guimier, M.4    Biscaro, M.5
  • 36
    • 79955140231 scopus 로고    scopus 로고
    • Getting to grips with the new European Union pharmacovigilance legislation
    • Waller P, (2011) Getting to grips with the new European Union pharmacovigilance legislation. Pharmacoepidemiol Drug Saf 20: 544-549.
    • (2011) Pharmacoepidemiol Drug Saf , vol.20 , pp. 544-549
    • Waller, P.1
  • 37
    • 84862777400 scopus 로고    scopus 로고
    • Adaptive licensing: taking the next step in the evolution of drug approval
    • Eichler HG, Oye K, Baird LG, Abadie E, Brown J, et al. (2012) Adaptive licensing: taking the next step in the evolution of drug approval. Clin Pharmacol Ther 91: 426-437.
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 426-437
    • Eichler, H.G.1    Oye, K.2    Baird, L.G.3    Abadie, E.4    Brown, J.5
  • 38
    • 84857227370 scopus 로고    scopus 로고
    • Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs?
    • Woodcock J, (2012) Evidence vs. access: can twenty-first-century drug regulation refine the tradeoffs? Clin Pharmacol Ther 91: 378-380.
    • (2012) Clin Pharmacol Ther , vol.91 , pp. 378-380
    • Woodcock, J.1
  • 39
    • 79960048069 scopus 로고    scopus 로고
    • Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response
    • Eichler HG, Abadie E, Breckenridge A, Flamion B, Gustafsson LL, et al. (2011) Bridging the efficacy-effectiveness gap: a regulator's perspective on addressing variability of drug response. Nat Rev Drug Discov 10: 495-506.
    • (2011) Nat Rev Drug Discov , vol.10 , pp. 495-506
    • Eichler, H.G.1    Abadie, E.2    Breckenridge, A.3    Flamion, B.4    Gustafsson, L.L.5
  • 40
    • 84859004974 scopus 로고    scopus 로고
    • Pragmatic randomised trials using routine electronic health records: putting them to the test
    • Staa TP, Goldacre B, Gulliford M, Cassell J, Pirmohamed M, et al. (2012) Pragmatic randomised trials using routine electronic health records: putting them to the test. BMJ 344: e55.
    • (2012) BMJ , vol.344
    • Staa, T.P.1    Goldacre, B.2    Gulliford, M.3    Cassell, J.4    Pirmohamed, M.5


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