메뉴 건너뛰기




Volumn 108, Issue 16, 1997, Pages 621-628

Coste, eficiencia y próximo futuro del desarrollo de nuevos fármacos

Author keywords

[No Author keywords available]

Indexed keywords

NEW DRUG;

EID: 0040710726     PISSN: 00257753     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article
Times cited : (7)

References (82)
  • 1
    • 0027324578 scopus 로고
    • The role of the research-based pharmaceutical industry in medical progress in the United States
    • Kaitin KI, Bryant NR, Lasagna L. The role of the research-based pharmaceutical industry in medical progress in the United States. J Clin Pharmacol 1993; 33: 412-417.
    • (1993) J Clin Pharmacol , vol.33 , pp. 412-417
    • Kaitin, K.I.1    Bryant, N.R.2    Lasagna, L.3
  • 2
    • 0024472206 scopus 로고
    • Novel medicines marketed in the UK (1960-87)
    • Lis Y, Walker SR. Novel medicines marketed in the UK (1960-87). Br J Clin Pharmacol 1989; 28: 333-343.
    • (1989) Br J Clin Pharmacol , vol.28 , pp. 333-343
    • Lis, Y.1    Walker, S.R.2
  • 3
    • 0027093596 scopus 로고
    • A decade of global pharmaceutical R & D expenditure (1981-1990)
    • Halliday RG, Drasdo AL, Lumley CE, Walker RS. A decade of global pharmaceutical R & D expenditure (1981-1990). Pharm Med 1992; 6: 281-296.
    • (1992) Pharm Med , vol.6 , pp. 281-296
    • Halliday, R.G.1    Drasdo, A.L.2    Lumley, C.E.3    Walker, R.S.4
  • 4
    • 0028242491 scopus 로고
    • Drug discovery on the assembly line
    • Alper J. Drug discovery on the assembly line. Science 1994; 264: 1.399-1.401.
    • (1994) Science , vol.264 , pp. 1399-1401
    • Alper, J.1
  • 5
    • 2542629556 scopus 로고
    • Monografías de la Real Academia de Farmacia
    • Madrid: Farmaindustria
    • Monografías de la Real Academia de Farmacia. Diseño de medicamentos. Madrid: Farmaindustria, 1994.
    • (1994) Diseño de Medicamentos
  • 6
    • 0029144835 scopus 로고
    • Gene therapy's growing pains
    • Marshall E. Gene therapy's growing pains. Science 1995; 269: 1.050-1.055.
    • (1995) Science , vol.269 , pp. 1050-1055
    • Marshall, E.1
  • 7
    • 0026530097 scopus 로고
    • Human gene therapy
    • Anderson WF. Human gene therapy. Science 1992: 256: 808-813.
    • (1992) Science , vol.256 , pp. 808-813
    • Anderson, W.F.1
  • 8
    • 0029134946 scopus 로고
    • Gene therapy, promise, pitfalls, and prognosis
    • Leiden JM. Gene therapy, promise, pitfalls, and prognosis. N Engl J Med 1995; 333: 871-873.
    • (1995) N Engl J Med , vol.333 , pp. 871-873
    • Leiden, J.M.1
  • 14
    • 0028213640 scopus 로고
    • Risks, regulation and rewards in new drug development in the United States
    • DiMasi JA. Risks, regulation and rewards in new drug development in the United States. Regul Toxicol Pharmacol 1994; 19: 228-235.
    • (1994) Regul Toxicol Pharmacol , vol.19 , pp. 228-235
    • DiMasi, J.A.1
  • 15
    • 0001647605 scopus 로고
    • A new look at the returns and risks to pharmaceutical R & D
    • Grabowski H, Vernon J. A new look at the returns and risks to pharmaceutical R & D. Management Science 1990; 36: 804-821.
    • (1990) Management Science , vol.36 , pp. 804-821
    • Grabowski, H.1    Vernon, J.2
  • 16
    • 0029093760 scopus 로고
    • The economics of healthcare: Funding and rewarding the usage and the benefits of pharmaceutical
    • Towse A. The economics of healthcare: funding and rewarding the usage and the benefits of pharmaceutical. Pharm Med 1995; 9: 129-133.
    • (1995) Pharm Med , vol.9 , pp. 129-133
    • Towse, A.1
  • 19
    • 0026713076 scopus 로고
    • R&D philosophy and management in the world's leading pharmaceutical companies
    • Halliday RG, Walker SR, Lumley CE. R&D philosophy and management in the world's leading pharmaceutical companies. J Pharm Med 1992; 2: 139-154.
    • (1992) J Pharm Med , vol.2 , pp. 139-154
    • Halliday, R.G.1    Walker, S.R.2    Lumley, C.E.3
  • 20
    • 0028455313 scopus 로고
    • New drug development in the United States from 1963 to 1992
    • DiMasi JA, Seibring MA, Lasagna L. New drug development in the United States from 1963 to 1992. Clin Pharmacol Ther 1994; 55: 609-622.
    • (1994) Clin Pharmacol Ther , vol.55 , pp. 609-622
    • DiMasi, J.A.1    Seibring, M.A.2    Lasagna, L.3
  • 22
    • 0029128834 scopus 로고
    • Success rates for new drugs entering clinical testing in the United States
    • DiMasi JA. Success rates for new drugs entering clinical testing in the United States. Clin Pharmacol Ther 1995; 58: 1-14.
    • (1995) Clin Pharmacol Ther , vol.58 , pp. 1-14
    • DiMasi, J.A.1
  • 23
    • 0023947965 scopus 로고
    • Pharmaceutical innovation by seven UK-owned pharmaceutical companies (1964-1984)
    • Pentris RA, Lis Y, Walker SR. Pharmaceutical innovation by seven UK-owned pharmaceutical companies (1964-1984). Br J Clin Pharmacol 1988; 25: 387-396.
    • (1988) Br J Clin Pharmacol , vol.25 , pp. 387-396
    • Pentris, R.A.1    Lis, Y.2    Walker, S.R.3
  • 24
    • 0029029695 scopus 로고
    • Executive summary: White paper of four areas of relevance to new drug development and review in the United States
    • Tufts Center for the Study of Drug Development Executive summary: white paper of four areas of relevance to new drug development and review in the United States. Drug Infor J 1995; 29: 357-359.
    • (1995) Drug Infor J , vol.29 , pp. 357-359
  • 26
    • 0028126652 scopus 로고
    • New chemical entity output of the international pharmaceutical industry from 1970 to 1992
    • Maclnnes R, Lumley CE, Walker SR. New chemical entity output of the international pharmaceutical industry from 1970 to 1992. Clin Pharmacol Ther 1994; 56: 339-349.
    • (1994) Clin Pharmacol Ther , vol.56 , pp. 339-349
    • Maclnnes, R.1    Lumley, C.E.2    Walker, S.R.3
  • 27
    • 2542541168 scopus 로고
    • Fewer NCEs reach the market in the 1990s
    • Maclnnes R. Fewer NCEs reach the market in the 1990s. CMR News 1995; 13: 1-2.
    • (1995) CMR News , vol.13 , pp. 1-2
    • Maclnnes, R.1
  • 28
    • 2542570085 scopus 로고
    • Forty new chemical entities and biologicals first launched in 1994
    • MacFarlane F. Forty new chemical entities and biologicals first launched in 1994. CMR News 1995; 13: 5-7.
    • (1995) CMR News , vol.13 , pp. 5-7
    • MacFarlane, F.1
  • 29
    • 2542570085 scopus 로고
    • New chemical entities and biologicals first launched in 1994 [fe ce errores]
    • New chemical entities and biologicals first launched in 1994 [fe ce errores]. CMR News 1995; 13: 5.
    • (1995) CMR News , vol.13 , pp. 5
  • 30
    • 0028279141 scopus 로고
    • The new drugs approvals of 1990, 1991 and 1992: Trends in drug development
    • Kaitin KI, Manocchia M, Seibring M, Lasagna L. The new drugs approvals of 1990, 1991 and 1992: trends in drug development. J Clin Pharmacol 1994; 34: 120-127.
    • (1994) J Clin Pharmacol , vol.34 , pp. 120-127
    • Kaitin, K.I.1    Manocchia, M.2    Seibring, M.3    Lasagna, L.4
  • 31
    • 0029082303 scopus 로고
    • The growing need for economic assessments: Implications for pharmaceutical medicine
    • Drummond M. The growing need for economic assessments: implications for pharmaceutical medicine. Pharm Med 1995; 9: 115-122.
    • (1995) Pharm Med , vol.9 , pp. 115-122
    • Drummond, M.1
  • 33
    • 0028989207 scopus 로고
    • Editorial. Quality of life and clinical trials
    • Editorial. Quality of life and clinical trials. Lancet 1995; 346: 1-2.
    • (1995) Lancet , vol.346 , pp. 1-2
  • 34
    • 0029094869 scopus 로고
    • Pharmacoeconomics: A challenge for clinical pharmacologists
    • Walley T, Davey P. Pharmacoeconomics: a challenge for clinical pharmacologists. Br J Clin Pharmacol 1995; 40: 199-202.
    • (1995) Br J Clin Pharmacol , vol.40 , pp. 199-202
    • Walley, T.1    Davey, P.2
  • 37
    • 0023176872 scopus 로고
    • Trends in drug development: The 1985-86 new drug approvals
    • Kaitin KI, Richard BW, Lasagna L Trends in drug development: the 1985-86 new drug approvals. J Clin Pharmacol 1987; 27: 542-548.
    • (1987) J Clin Pharmacol , vol.27 , pp. 542-548
    • Kaitin, K.I.1    Richard, B.W.2    Lasagna, L.3
  • 38
    • 0026099268 scopus 로고
    • The new drug approvals of 1987, 1988 and 1989: Trends in drug development
    • Kaitin KI, DiCerbo PA, Lasagna L. The new drug approvals of 1987, 1988 and 1989: trends in drug development. J Clin Pharmacol 1991; 31: 116-122.
    • (1991) J Clin Pharmacol , vol.31 , pp. 116-122
    • Kaitin, K.I.1    DiCerbo, P.A.2    Lasagna, L.3
  • 39
    • 0015896840 scopus 로고
    • Introduction of new therapeutic drugs in the United States and Great Britain: An international comparison
    • Wardell WM. Introduction of new therapeutic drugs in the United States and Great Britain: an international comparison. Clin Pharmacol Ther 1973; 14: 773-790.
    • (1973) Clin Pharmacol Ther , vol.14 , pp. 773-790
    • Wardell, W.M.1
  • 40
    • 0018239511 scopus 로고
    • The drug lag revisited: Comparison by therapeutic area of patterns of drug marketed in the United States and Great Britain from 1972 through 1976
    • Wardell WM. The drug lag revisited: comparison by therapeutic area of patterns of drug marketed in the United States and Great Britain from 1972 through 1976. Clin Pharmacol Ther 1978; 24: 499-524.
    • (1978) Clin Pharmacol Ther , vol.24 , pp. 499-524
    • Wardell, W.M.1
  • 41
    • 0024467891 scopus 로고
    • The drug lag: An update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987
    • Kaitin KI, Mattison N, Northington FK, Lasagna L. The drug lag: an update of new drug introductions in the United States and in the United Kingdom, 1977 through 1987. Clin Pharmacol Ther 1989; 46: 121-138.
    • (1989) Clin Pharmacol Ther , vol.46 , pp. 121-138
    • Kaitin, K.I.1    Mattison, N.2    Northington, F.K.3    Lasagna, L.4
  • 42
    • 0027146318 scopus 로고
    • A comparison of the review of a cohort of NCEs by four national regulatory authorities
    • Harvey C, Lumley CE, Walker SR. A comparison of the review of a cohort of NCEs by four national regulatory authorities. J Pharm Med 1993; 3: 65-75.
    • (1993) J Pharm Med , vol.3 , pp. 65-75
    • Harvey, C.1    Lumley, C.E.2    Walker, S.R.3
  • 44
    • 0029129057 scopus 로고
    • Drug safety discontinuation in the United Kingdom, the United States and Spain from 1974 through 1993: A regulatory perspective
    • Bakke OM, Manocchia M, De Abajo F, Kaitin KI, Lasagna L. Drug safety discontinuation in the United Kingdom, the United States and Spain from 1974 through 1993: a regulatory perspective. Clin Pharmacol Ther 1995; 58: 108-117.
    • (1995) Clin Pharmacol Ther , vol.58 , pp. 108-117
    • Bakke, O.M.1    Manocchia, M.2    De Abajo, F.3    Kaitin, K.I.4    Lasagna, L.5
  • 45
    • 0026691466 scopus 로고
    • Are initiatives to speed the new drug approval process working?
    • Kaitin KI, Walsh HL. Are initiatives to speed the new drug approval process working? Drug Infor J 1992; 26: 341-349.
    • (1992) Drug Infor J , vol.26 , pp. 341-349
    • Kaitin, K.I.1    Walsh, H.L.2
  • 47
    • 0029069733 scopus 로고
    • Registration of drugs for treating cancer and HIV infection: A plea to carry out phase 3 trials before admission to the market
    • Koopmans PP. Registration of drugs for treating cancer and HIV infection: a plea to carry out phase 3 trials before admission to the market. Br Med J 1995; 310: 1.305-1.306.
    • (1995) Br Med J , vol.310 , pp. 1305-1306
    • Koopmans, P.P.1
  • 48
    • 0027954075 scopus 로고
    • Innovation in the pharmaceutical industry
    • Sykes R. Innovation in the pharmaceutical industry. Br Med J 1994; 309: 422-423.
    • (1994) Br Med J , vol.309 , pp. 422-423
    • Sykes, R.1
  • 49
    • 0027446482 scopus 로고
    • Biopharmaceuticals go to market: Patterns of worldwide development
    • Bienz-Tadmor B. Biopharmaceuticals go to market: patterns of worldwide development. Bio/Technology 1993; 11: 168-172.
    • (1993) Bio/Technology , vol.11 , pp. 168-172
    • Bienz-Tadmor, B.1
  • 50
    • 0022574893 scopus 로고
    • Industrial support of university research in biotechnology
    • Blumenthal D, Gluck M, Louis KS, Wise D. Industrial support of university research in biotechnology. Science 1986; 231: 242-246.
    • (1986) Science , vol.231 , pp. 242-246
    • Blumenthal, D.1    Gluck, M.2    Louis, K.S.3    Wise, D.4
  • 51
    • 14744298009 scopus 로고
    • Biopharmaceuticals and conventional drugs: Clinical success rates
    • Bienz-Tadmor B, Dicerbo PA, Tadmor G, Lasagna L. Biopharmaceuticals and conventional drugs: clinical success rates. Bio/Technology 1992; 10: 521-525.
    • (1992) Bio/Technology , vol.10 , pp. 521-525
    • Bienz-Tadmor, B.1    Dicerbo, P.A.2    Tadmor, G.3    Lasagna, L.4
  • 52
    • 0007577765 scopus 로고
    • Biopharmaceuticals and conventional drugs: Comparing development times
    • Bienz-Tadmor B, Brown J. Biopharmaceuticals and conventional drugs: comparing development times. Bio Pharm 1994; 7: 44-49.
    • (1994) Bio Pharm , vol.7 , pp. 44-49
    • Bienz-Tadmor, B.1    Brown, J.2
  • 53
    • 2542544163 scopus 로고
    • UK pharma facts and figures-R&D
    • UK pharma facts and figures-R&D. Script 1993; 1878: 6-7.
    • (1993) Script , vol.1878 , pp. 6-7
  • 54
    • 2542626546 scopus 로고
    • Italian R&D spending in 1994
    • Italian R&D spending in 1994. Script 1995; 2056/57: 6.
    • (1995) Script , vol.2056 , Issue.57 , pp. 6
  • 55
    • 2542515259 scopus 로고
    • French R&D spend static
    • French R&D spend static. Scrip 1995; 2047: 4.
    • (1995) Scrip , vol.2047 , pp. 4
  • 56
    • 0029023943 scopus 로고
    • World-wide pharmaceutical research and development expenditure: 1981-91 and current trends
    • MacFarlane FG, Kunze ZM, Drasdo AL, Lumley CE, Walker SR. World-wide pharmaceutical research and development expenditure: 1981-91 and current trends J Pharm Med 1995; 5: 17-31.
    • (1995) J Pharm Med , vol.5 , pp. 17-31
    • MacFarlane, F.G.1    Kunze, Z.M.2    Drasdo, A.L.3    Lumley, C.E.4    Walker, S.R.5
  • 57
    • 0025960537 scopus 로고
    • Clinical research disturbing present, uncertain future
    • Clinical research disturbing present, uncertain future [editorial]. Lancet 1991; 337: 19-20.
    • (1991) Lancet , vol.337 , pp. 19-20
  • 58
    • 0029055798 scopus 로고
    • Harnessing the profit motive
    • Harnessing the profit motive [editorial]. Lancet 1995; 345: 1.189-1.190.
    • (1995) Lancet , vol.345 , pp. 1189-1190
  • 59
    • 0026557979 scopus 로고
    • European research: Back to pre-eminence
    • Smith R. European research: back to pre-eminence. Br Med J 1992; 304: 899-903.
    • (1992) Br Med J , vol.304 , pp. 899-903
    • Smith, R.1
  • 60
    • 2542545665 scopus 로고
    • FY 1994 Federal budgets for R&D in biology: NSF, CDC see improvements, but NIH, USDA, DOE fare badly
    • FY 1994 Federal budgets for R&D in biology: NSF, CDC see improvements, but NIH, USDA, DOE fare badly ASM News 1993; 59: 274-276.
    • (1993) ASM News , vol.59 , pp. 274-276
  • 61
    • 2542551802 scopus 로고
    • USA clinical research must seek new funding sources
    • Rowe PM. USA clinical research must seek new funding sources Lancet 1995; 346: 173.
    • (1995) Lancet , vol.346 , pp. 173
    • Rowe, P.M.1
  • 62
    • 2542588464 scopus 로고
    • Roche tops 1994 R&D spend rankings
    • Roche tops 1994 R&D spend rankings. Scrip 1995; 2048: 10.
    • (1995) Scrip , vol.2048 , pp. 10
  • 63
    • 2542605198 scopus 로고
    • Top pharma companies
    • Top pharma companies. Scrip 1995; 2041: 6.
    • (1995) Scrip , vol.2041 , pp. 6
  • 64
    • 2542538153 scopus 로고
    • Innovations in R&D: Can the pharmaceutical industry still deliver?
    • Drews J. Innovations in R&D: can the pharmaceutical industry still deliver? CMR News 1995; 13: 2.
    • (1995) CMR News , vol.13 , pp. 2
    • Drews, J.1
  • 65
    • 0029095136 scopus 로고
    • Bigger companies for better drugs?
    • Bigger companies for better drugs? [editorial]. Lancet 1995; 346: 585-586.
    • (1995) Lancet , vol.346 , pp. 585-586
  • 66
    • 2542621976 scopus 로고
    • How is foreing clinical data used in regulatory submissions?
    • Thomas K. How is foreing clinical data used in regulatory submissions? CMR News 1995; 13: 7.
    • (1995) CMR News , vol.13 , pp. 7
    • Thomas, K.1
  • 67
    • 0027286609 scopus 로고
    • Trends in pharmaceutical development
    • Temple R. Trends in pharmaceutical development. Drug Inform J 1993; 27: 355-366.
    • (1993) Drug Inform J , vol.27 , pp. 355-366
    • Temple, R.1
  • 68
    • 2542522931 scopus 로고
    • Second International Harmonization Conference
    • Second International Harmonization Conference. Regul Affairs J 1993; 4: 1.008-1.014.
    • (1993) Regul Affairs J , vol.4 , pp. 1008-1014
  • 69
    • 0028338817 scopus 로고
    • International conference on harmonization of technology requirements for registration of pharmaceuticals for human use (ICH)
    • Barber N. International conference on harmonization of technology requirements for registration of pharmaceuticals for human use (ICH). Br J Clin Pharmacol 1994; 37: 401-404.
    • (1994) Br J Clin Pharmacol , vol.37 , pp. 401-404
    • Barber, N.1
  • 70
    • 0029084713 scopus 로고
    • The international conference on harmonization
    • Vozeh S. The international conference on harmonization Eur J Clin Pharmacol 1995; 48: 173-175.
    • (1995) Eur J Clin Pharmacol , vol.48 , pp. 173-175
    • Vozeh, S.1
  • 71
    • 0037986190 scopus 로고    scopus 로고
    • ICH3, «global dossier» in sight, but issues remain
    • ICH3, «global dossier» in sight, but issues remain. Script 1996; 2084: 20-22.
    • (1996) Script , vol.2084 , pp. 20-22
  • 73
    • 0010433756 scopus 로고
    • The impact of cost containment on pharmaceutical research and development
    • Carshalton: CMR
    • Drews J. The impact of cost containment on pharmaceutical research and development. The CMR annual lecture. Carshalton: CMR, 1995.
    • (1995) The CMR Annual Lecture
    • Drews, J.1
  • 74
    • 0029100239 scopus 로고
    • A controlled study of adenoviral-vector-mediated gene transfer in the nasal epithelium of patients with cystic fibrosis
    • Knowles MR, Hohneker KW, Zhou Z, Olsen JC, Noah TL, Hu PC et al. A controlled study of adenoviral-vector-mediated gene transfer in the nasal epithelium of patients with cystic fibrosis. N Engl J Med 1995; 333: 823-831.
    • (1995) N Engl J Med , vol.333 , pp. 823-831
    • Knowles, M.R.1    Hohneker, K.W.2    Zhou, Z.3    Olsen, J.C.4    Noah, T.L.5    Hu, P.C.6
  • 77
    • 0039525341 scopus 로고
    • Investigatión académica e investigación industrial en el desarrollo de fármacos
    • Barc
    • Erill S. Investigatión académica e investigación industrial en el desarrollo de fármacos. Med Clin (Barc) 1987; 89: 247-249.
    • (1987) Med Clin , vol.89 , pp. 247-249
    • Erill, S.1
  • 78
    • 0025952135 scopus 로고
    • Clinical pharmacology, mutual benefits from greater collaboration between academia and the pharmaceutical industry
    • Posner J. Clinical pharmacology, mutual benefits from greater collaboration between academia and the pharmaceutical industry. Br J Clin Pharmacol 1991; 32: 531-533.
    • (1991) Br J Clin Pharmacol , vol.32 , pp. 531-533
    • Posner, J.1
  • 79
    • 0026484410 scopus 로고
    • Academic-industry relationships in life sciences
    • Blumenthal D. Academic-industry relationships in life sciences. JAMA 1992; 268: 3.344-3.349.
    • (1992) JAMA , vol.268 , pp. 3344-3349
    • Blumenthal, D.1
  • 80
    • 0029336506 scopus 로고
    • Conflicto de intereses e investigación clínica
    • Barc
    • Camí J. Conflicto de intereses e investigación clínica. Med Clin (Barc) 1995; 105: 174-179.
    • (1995) Med Clin , vol.105 , pp. 174-179
    • Camí, J.1
  • 81
    • 0029654140 scopus 로고
    • Science in stationary phase
    • Kornberg A. Science in stationary phase. Science 1995; 269: 1.799.
    • (1995) Science , vol.269 , pp. 1799
    • Kornberg, A.1
  • 82
    • 2542580766 scopus 로고
    • Trends in pharmaceutical R&D expenditure 1981-1993
    • Lumley C, Trends in pharmaceutical R&D expenditure 1981-1993. CMR News 1995; 13: 1-3.
    • (1995) CMR News , vol.13 , pp. 1-3
    • Lumley, C.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.