메뉴 건너뛰기




Volumn 32, Issue 4, 2007, Pages 399-431

Deficits, expectations and paradigms in British and American drug safety assessments: Prising open the black box of regulatory science

Author keywords

International comparison; Medicines safety regulation; Pharmaceutical innovation

Indexed keywords


EID: 34548176034     PISSN: 01622439     EISSN: 15528251     Source Type: Journal    
DOI: 10.1177/0162243907301002     Document Type: Article
Times cited : (36)

References (103)
  • 2
    • 0013545849 scopus 로고
    • Dr John Griffin takes over as ABPI chief
    • ABPI (Association of the British Pharmaceutical Industry)
    • ABPI (Association of the British Pharmaceutical Industry). 1984a. Dr John Griffin takes over as ABPI chief. ABPI News 198: 1.
    • (1984) ABPI News , vol.198 , pp. 1
  • 3
    • 0003188601 scopus 로고
    • New ABPI director stresses importance of two-way flow between Medicines Division and industry
    • ABPI (Association of the British Pharmaceutical Industry)
    • ABPI (Association of the British Pharmaceutical Industry). 1984 b. New ABPI director stresses importance of two-way flow between Medicines Division and industry. ABPI News 198: 3.
    • (1984) ABPI News , vol.198 , pp. 3
  • 4
    • 21144481490 scopus 로고
    • Scientific standards and institutional interests: Carcinogenic risk assessment of benoxaprofen in the UK and US
    • Abraham, J. 1993. Scientific standards and institutional interests: Carcinogenic risk assessment of benoxaprofen in the UK and US. Social Studies of Science 23:387-444.
    • (1993) Social Studies of Science , vol.23 , pp. 387-444
    • Abraham, J.1
  • 6
    • 33645578025 scopus 로고    scopus 로고
    • The political economy of medicines regulation in Britain
    • ABPI (Association of the British Pharmaceutical Industry). In edited by H. Lawton Smith Basingstoke: Palgrave
    • ABPI (Association of the British Pharmaceutical Industry). 2002. The political economy of medicines regulation in Britain. In The regulation of science and technology, edited by H. Lawton Smith, 221-63. Basingstoke: Palgrave.
    • (2002) The Regulation of Science and Technology , pp. 221-263
  • 7
    • 0036464130 scopus 로고    scopus 로고
    • Citizenship, medical expertise and the capitalist regulatory state in Europe
    • Abraham, J., and G. Lewis. 2002. Citizenship, medical expertise and the capitalist regulatory state in Europe. Sociology 36:67-88.
    • (2002) Sociology , vol.36 , pp. 67-88
    • Abraham, J.1    Lewis, G.2
  • 8
    • 38249025661 scopus 로고
    • Food additive controls: Some international comparisons
    • Abraham, J., and E. Millstone. 1989. Food additive controls: Some international comparisons. Food Policy 14:43-57.
    • (1989) Food Policy , vol.14 , pp. 43-57
    • Abraham, J.1    Millstone, E.2
  • 9
    • 0034828153 scopus 로고    scopus 로고
    • Trading risks for markets: The international harmonisation of pharmaceuticals regulation
    • Abraham, J., and T. Reed. 2001. Trading risks for markets: The international harmonisation of pharmaceuticals regulation. Health, Risk & Society 3:113-28.
    • (2001) Health, Risk & Society , vol.3 , pp. 113-128
    • Abraham, J.1    Reed, T.2
  • 10
    • 0036617041 scopus 로고    scopus 로고
    • Progress, innovation and regulatory science
    • Abraham, J., and T. Reed. 2002. Progress, innovation and regulatory science. Social Studies of Science 32: 337-70.
    • (2002) Social Studies of Science , vol.32 , pp. 337-370
    • Abraham, J.1    Reed, T.2
  • 11
    • 0031082660 scopus 로고    scopus 로고
    • Democracy, technocracy and the secret state of medicines control
    • Abraham, J., and J. Sheppard. 1997. Democracy, technocracy and the secret state of medicines control. Science, Technology, & Human Values 22:139-67.
    • (1997) Science, Technology, & Human Values , vol.22 , pp. 139-167
    • Abraham, J.1    Sheppard, J.2
  • 13
    • 0026580288 scopus 로고
    • The drug lag issue: The debate seen from an international perspective
    • Andersson, F. 1992. The drug lag issue: The debate seen from an international perspective. International Journal of Health Services 22:53-72.
    • (1992) International Journal of Health Services , vol.22 , pp. 53-72
    • Andersson, F.1
  • 15
    • 34548181890 scopus 로고
    • Present and future non-steroidal anti-inflammatories in the US
    • Anon
    • Anon. 1978a. Present and future non-steroidal anti-inflammatories in the US. Scrip 268:24-25.
    • (1978) Scrip , vol.268 , pp. 24-25
  • 16
    • 34548169427 scopus 로고
    • Reckitt & Colman launches new anti-inflammatory in UK
    • Anon
    • Anon. 1978b. Reckitt & Colman launches new anti-inflammatory in UK. Scrip 323:9.
    • (1978) Scrip , vol.323 , pp. 9
  • 17
    • 34548180440 scopus 로고
    • Carlo Erba's anti-inflammatory does well in trial
    • Anon
    • Anon. 1978c. Carlo Erba's anti-inflammatory does well in trial. Scrip 275:23.
    • (1978) Scrip , vol.275 , pp. 23
  • 18
    • 34548189865 scopus 로고
    • World anti-arthritic market should reach $2,400 million by 1984
    • Anon
    • Anon. 1980. World anti-arthritic market should reach $2,400 million by 1984. Scrip 500:8.
    • (1980) Scrip , vol.500 , pp. 8
  • 19
    • 0019480296 scopus 로고
    • Choosing a non-steroidal anti-inflammatory drug
    • Anon
    • Anon. 1981. Choosing a non-steroidal anti-inflammatory drug. Drug and Therapeutics Bulletin 19:53-56.
    • (1981) Drug and Therapeutics Bulletin , vol.19 , pp. 53-56
  • 20
    • 34548172296 scopus 로고
    • Farmitalia (UK) launches Flosint
    • Anon
    • Anon. 1982. Farmitalia (UK) launches Flosint. Scrip 735: 7.
    • (1982) Scrip , vol.735 , pp. 7
  • 21
    • 34548158805 scopus 로고
    • Flosint's UK PL suspended
    • Anon
    • Anon. 1983a. Flosint's UK PL suspended. Scrip 856:1-3.
    • (1983) Scrip , vol.856 , pp. 1-3
  • 22
    • 34548157820 scopus 로고
    • Disease-modifying claim for Flenac
    • Anon
    • Anon. 1983b. Disease-modifying claim for Flenac. Scrip 847:15.
    • (1983) Scrip , vol.847 , pp. 15
  • 23
    • 34548188846 scopus 로고
    • Oxicam hearing in FRG
    • Anon
    • Anon. 1983c. Oxicam hearing in FRG. Scrip 836:1-5.
    • (1983) Scrip , vol.836 , pp. 1-5
  • 24
    • 34548191112 scopus 로고
    • Flenac's ADR incidence
    • Anon
    • Anon. 1984a. Flenac's ADR incidence. Scrip 914:18.
    • (1984) Scrip , vol.914 , pp. 18
  • 25
    • 34548184250 scopus 로고
    • Nabumetone's potential outlined
    • Anon
    • Anon. 1984b. Nabumetone's potential outlined. Scrip 916:11-14.
    • (1984) Scrip , vol.916 , pp. 11-14
  • 26
    • 34548175289 scopus 로고
    • Scrip's review of 1984
    • Anon
    • Anon. 1984c. Scrip's review of 1984. Scrip 959:3-4.
    • (1984) Scrip , vol.959 , pp. 3-4
  • 27
    • 34548175806 scopus 로고
    • Lead-up to Flosint's PL suspension
    • Anon
    • Anon. 1984d. Lead-up to Flosint's PL suspension. Scrip 859:6-7.
    • (1984) Scrip , vol.859 , pp. 6-7
  • 28
    • 34548155561 scopus 로고
    • CSM recommends against Flosint return
    • Anon
    • Anon. 1984e. CSM recommends against Flosint return. Scrip 878:3.
    • (1984) Scrip , vol.878 , pp. 3
  • 29
    • 34548167873 scopus 로고
    • CSM on NSAI ADRs. Part 2
    • Anon
    • Anon. 1986. CSM on NSAI ADRs. Part 2. Scrip 1102:25-27.
    • (1986) Scrip , vol.1102 , pp. 25-27
  • 30
    • 34548147113 scopus 로고
    • US vs UK new chemical entities (NCEs) between 1970-1988
    • Anon
    • Anon. 1989. US vs UK new chemical entities (NCEs) between 1970-1988. Scrip 1472: 30-32.
    • (1989) Scrip , vol.1472 , pp. 30-32
  • 31
    • 0005633219 scopus 로고
    • Dear Lilly Associate
    • Letter from managing director of Lilly Industries UK, March 3
    • Bailey, R. 1988. Dear Lilly Associate. Letter from managing director of Lilly Industries UK, March 3.
    • (1988)
    • Bailey, R.1
  • 32
    • 34548165607 scopus 로고
    • July 22. New Drug Application for indoprofen (END 0160). Washington, DC: Food and Drug Administration
    • Barker, E.F. 1982. Clinical review of NDA 18-617 (indoprofen), July 22. New Drug Application for indoprofen (END 0160). Washington, DC: Food and Drug Administration.
    • (1982) Clinical Review of NDA 18-617 (indoprofen)
    • Barker, E.F.1
  • 33
    • 20444408831 scopus 로고
    • internal memorandum, May 25. New Drug Application for indoprofen (END 0154). Washington, DC: Food and Drug Administration
    • Barker, E.F. 1984. Endyne, internal memorandum, May 25. New Drug Application for indoprofen (END 0154). Washington, DC: Food and Drug Administration.
    • (1984) Endyne
    • Barker, E.F.1
  • 34
    • 34548149796 scopus 로고
    • The Opren Scandal
    • Bbc. January 10
    • Bbc. 1983. The Opren Scandal. Panorama January 10.
    • (1983) Panorama
  • 35
    • 0020264281 scopus 로고
    • Radiologic assessment of benoxaprofen therapy in rheumatoid arthritis
    • Bluhm, G.B. 1982. Radiologic assessment of benoxaprofen therapy in rheumatoid arthritis. European Journal of Rheumatology and Inflammation 5:186-97.
    • (1982) European Journal of Rheumatology and Inflammation , vol.5 , pp. 186-197
    • Bluhm, G.B.1
  • 36
    • 0002206561 scopus 로고
    • Regulatory science and the social management of trust in medicine
    • In edited by W. E. Bijker, T. Hughes, and T. Pinch Cambridge, MA: MIT Press
    • Bodewitz, H.J.H.W., H. Buurma, and G.H. de Vries. 1987. Regulatory science and the social management of trust in medicine. In The social construction of technological systems, edited by W. E. Bijker, T. Hughes, and T. Pinch, 243-59. Cambridge, MA: MIT Press.
    • (1987) The Social Construction of Technological Systems , pp. 243-259
    • Bodewitz, H.J.H.W.1    Buurma, H.2    de Vries, G.H.3
  • 40
    • 34548154331 scopus 로고
    • Cbs. Sixty Minutes, April 17
    • Cbs. 1983. Oraflex. Sixty Minutes, April 17.
    • (1983) Oraflex
  • 41
    • 0141860900 scopus 로고    scopus 로고
    • The precautionary principle and democratizing expertise: A European legal perspective
    • Christoforou, T. 2003. The precautionary principle and democratizing expertise: A European legal perspective. Science and Public Policy 30:205-211.
    • (2003) Science and Public Policy , vol.30 , pp. 205-211
    • Christoforou, T.1
  • 42
    • 34548161730 scopus 로고
    • September 15. New Drug Application for Fenclofenac (FLE 0341). Washington, DC: Food and Drug Administration
    • Coulter, A.W. 1981. Pharmacology and toxicology review of NDA 18-619 (fenclofenac), September 15. New Drug Application for Fenclofenac (FLE 0341). Washington, DC: Food and Drug Administration.
    • (1981) Pharmacology and Toxicology Review of NDA 18-619 (fenclofenac)
    • Coulter, A.W.1
  • 43
    • 34548161730 scopus 로고
    • June 29. New Drug Application for Fenclofenac (FLE 0519). Washington, DC: Food and Drug Administration
    • Coulter, A.W. 1984. Pharmacology and toxicology review of NDA 18-619 (fenclofenac), June 29. New Drug Application for Fenclofenac (FLE 0519). Washington, DC: Food and Drug Administration.
    • (1984) Pharmacology and Toxicology Review of NDA 18-619 (fenclofenac)
    • Coulter, A.W.1
  • 44
    • 0022624322 scopus 로고
    • CSM Update: Non-steroidal anti-inflammatory drugs and serious gastrointestinal adverse reactions. Part 2
    • Csm
    • Csm. 1986. CSM Update: Non-steroidal anti-inflammatory drugs and serious gastrointestinal adverse reactions. Part 2. British Medical Journal 292: 1190-1.
    • (1986) British Medical Journal , vol.292 , pp. 1190-1191
  • 45
    • 0036557424 scopus 로고    scopus 로고
    • A tale of two experts: Thalidomide and political engagement in the United States and West Germany
    • Daemmrich, A. 2002. A tale of two experts: Thalidomide and political engagement in the United States and West Germany. Social History of Medicine 15:137-58.
    • (2002) Social History of Medicine , vol.15 , pp. 137-158
    • Daemmrich, A.1
  • 47
    • 0037648454 scopus 로고    scopus 로고
    • Risk versus risk: Decision-making dilemmas in the US and Germany
    • Daemmrich, A., and G. Krücken. 2000. Risk versus risk: Decision-making dilemmas in the US and Germany. Science as Culture 9:505-34.
    • (2000) Science As Culture , vol.9 , pp. 505-534
    • Daemmrich, A.1    Krücken, G.2
  • 48
    • 0001130039 scopus 로고
    • Drugs watchdogs and the drug industry
    • Delamothe, T. 1989. Drugs watchdogs and the drug industry. British Medical Journal 299:476.
    • (1989) British Medical Journal , vol.299 , pp. 476
    • Delamothe, T.1
  • 50
    • 34548174279 scopus 로고
    • Background analysis in promotional materials for company sales representatives
    • Eli Lilly. 1982. Background analysis in promotional materials for company sales representatives.
    • (1982)
    • Eli, L.1
  • 52
    • 34548166363 scopus 로고
    • New Flosint (indoprofen): Towards mobility without pain (advertisement)
    • Farmitalia
    • Farmitalia. 1982. New Flosint (indoprofen): Towards mobility without pain (advertisement).
    • (1982)
  • 54
    • 34548186520 scopus 로고
    • Finkel Internal memorandum 26 October (FLE 0552). Washington, DC: Food and Drug Administration
    • Finkel 1981. Memorandum re: NDA 18-619 (fenclofenac). Internal memorandum 26 October (FLE 0552). Washington, DC: Food and Drug Administration.
    • (1981) Memorandum Re: NDA 18-619 (fenclofenac)
  • 55
    • 34548180176 scopus 로고
    • FDA (Food and Drug Administration). Adria Laboratories, December 20 (END 0134). Washington, DC: Food and Drug Administration
    • FDA (Food and Drug Administration). 1983. Memorandum of meeting re: NDA 18-617 Endyne (indoprofen), Adria Laboratories, December 20 (END 0134). Washington, DC: Food and Drug Administration.
    • (1983) Memorandum of Meeting Re: NDA 18-617 Endyne (indoprofen)
  • 56
    • 34548179948 scopus 로고    scopus 로고
    • FDA (Food and Drug Administration). Section 506(b)(3) of the Food, Drug and Cosmetic Act, amended by section 112 of FDAMA
    • FDA (Food and Drug Administration). FDA Modernisation Act. Section 506(b)(3) of the Food, Drug and Cosmetic Act, amended by section 112 of FDAMA.
    • FDA Modernisation Act
  • 59
    • 34548186989 scopus 로고
    • April 10. New Drug Application for Fenclofenac (FLE 0264). Washington, DC: Food and Drug Administration
    • Friedberg, M. 1984. Statistical review and evaluation, April 10. New Drug Application for Fenclofenac (FLE 0264). Washington, DC: Food and Drug Administration.
    • (1984) Statistical Review and Evaluation
    • Friedberg, M.1
  • 60
    • 0018619659 scopus 로고
    • Carcinogenic risk assessment in the United States and Great Britain: The case of Aldrin/Dieldrin
    • Gillespie, B., P. Eva, and R. Johnston. 1979. Carcinogenic risk assessment in the United States and Great Britain: The case of Aldrin/ Dieldrin. Social Studies of Science 9:265-301.
    • (1979) Social Studies of Science , vol.9 , pp. 265-301
    • Gillespie, B.1    Eva, P.2    Johnston, R.3
  • 61
    • 0036383022 scopus 로고    scopus 로고
    • Accommodating science to external demands: The emergence of Dutch toxicology
    • Groenewegen, P. 2002. Accommodating science to external demands: The emergence of Dutch toxicology. Science, Technology, & Human Values 27: 479-98.
    • (2002) Science, Technology, & Human Values , vol.27 , pp. 479-498
    • Groenewegen, P.1
  • 62
    • 34548178088 scopus 로고
    • October 26. New Drug Application for Fenclofenac (FLE 0026). Washington, DC: Food and Drug Administration
    • Harter, J. 1981. Supervisor's review sign off form, October 26. New Drug Application for Fenclofenac (FLE 0026). Washington, DC: Food and Drug Administration.
    • (1981) Supervisor's Review Sign Off Form
    • Harter, J.1
  • 64
    • 0038975903 scopus 로고
    • Hmso. London: Her Majesty's Stationery Office
    • Hmso. 1968. Medicines Act 1968. London: Her Majesty's Stationery Office.
    • (1968) Medicines Act 1968
  • 65
    • 84965794687 scopus 로고
    • Opren parliamentary debate
    • House of Commons. (27 January)
    • House of Commons. 1983. Opren parliamentary debate. Hansard (27 January): 573-85.
    • (1983) Hansard , pp. 573-585
  • 67
    • 0018763674 scopus 로고
    • Scientific basis for identification of potential carcinogens and estimation of risks
    • Interagency Regulatory Liaison Group
    • Interagency Regulatory Liaison Group. 1979. Scientific basis for identification of potential carcinogens and estimation of risks. Journal of the National Cancer Institute 63:241-68.
    • (1979) Journal of the National Cancer Institute , vol.63 , pp. 241-268
  • 68
    • 0002187837 scopus 로고    scopus 로고
    • Science and hell's kitchen: The local understanding of hazard issues
    • In edited by A. Irwin and B. Wynne Cambridge: Cambridge University Press
    • Irwin, A., A. Dale, and D. Smith. 1996. Science and hell's kitchen: The local understanding of hazard issues. In Misunderstanding science? The public reconstruction of science and technology, edited by A. Irwin and B. Wynne, 47-64. Cambridge: Cambridge University Press.
    • (1996) Misunderstanding Science? The Public Reconstruction of Science and Technology , pp. 47-64
    • Irwin, A.1    Dale, A.2    Smith, D.3
  • 72
    • 0032397530 scopus 로고    scopus 로고
    • Untangling context: Understanding a university laboratory in the commercial world
    • Kleinman, D.L. 1998. Untangling context: Understanding a university laboratory in the commercial world. Science, Technology, & Human Values 23:285-314.
    • (1998) Science, Technology, & Human Values , vol.23 , pp. 285-314
    • Kleinman, D.L.1
  • 74
    • 0028928635 scopus 로고
    • Revisiting the origins of "compulsory drug prescriptions"
    • Marks, H.M. 1995. Revisiting the origins of "compulsory drug prescriptions". American Journal of Public Health 85:109-115.
    • (1995) American Journal of Public Health , vol.85 , pp. 109-115
    • Marks, H.M.1
  • 75
    • 0033231992 scopus 로고    scopus 로고
    • "Not just a statistic": The history of USA and UK policy over thrombotic disease and the oral contraceptive pill, 1960s-1970s
    • Marks, L. 1999. "Not just a statistic": The history of USA and UK policy over thrombotic disease and the oral contraceptive pill, 1960s-1970s. Social Science & Medicine 49:1139-55.
    • (1999) Social Science & Medicine , vol.49 , pp. 1139-1155
    • Marks, L.1
  • 76
    • 0016384218 scopus 로고
    • Non-steroidal anti-inflammatory drugs
    • Mills, J.A. 1974. Non-steroidal anti-inflammatory drugs. New England Journal of Medicine 288:781.
    • (1974) New England Journal of Medicine , vol.288 , pp. 781
    • Mills, J.A.1
  • 77
    • 0035354450 scopus 로고    scopus 로고
    • Affiliation bias and expert disagreement in framing the nicotine addiction debate
    • Murphy, P. 2001. Affiliation bias and expert disagreement in framing the nicotine addiction debate. Science, Technology, & Human Values 26:278-99.
    • (2001) Science, Technology, & Human Values , vol.26 , pp. 278-299
    • Murphy, P.1
  • 78
    • 0020580361 scopus 로고
    • Non-steroidal analgesic and anti-inflammatory agents
    • Nuki, G. 1983. Non-steroidal analgesic and anti-inflammatory agents. British Medical Journal 287:39-43.
    • (1983) British Medical Journal , vol.287 , pp. 39-43
    • Nuki, G.1
  • 79
    • 0022964959 scopus 로고
    • Radiological evaluation of erosions: A quantitative method for assessing long-term remittive therapy in rheumatoid arthritis
    • O'Brien, W.M. 1986. Radiological evaluation of erosions: A quantitative method for assessing long-term remittive therapy in rheumatoid arthritis. British Journal of Clinical Pharmacology 22:173S-182S.
    • (1986) British Journal of Clinical Pharmacology , vol.22
    • O'Brien, W.M.1
  • 80
    • 34548162949 scopus 로고
    • Letter to Ronald Kartzinel, FDA, 20 June from James Page, Vice President, Medical Affairs, Adria Laboratories (END 0109)
    • Page, J.A. 1979. Re: IND 11-385 Indoprofen. Letter to Ronald Kartzinel, FDA, 20 June from James Page, Vice President, Medical Affairs, Adria Laboratories (END 0109).
    • (1979) Re: IND 11-385 Indoprofen
    • Page, J.A.1
  • 81
    • 34548170068 scopus 로고
    • Letter from the Acting Director
    • Division of Oncology and Radiopharmaceutical Drug Products, FDA to RT French Company (subsidiary of Reckitt & Colman), February 21 (FLE 0775)
    • Palmer, J.F. 1985. Letter from the Acting Director, Division of Oncology and Radiopharmaceutical Drug Products, FDA to RT French Company (subsidiary of Reckitt & Colman), February 21 (FLE 0775).
    • (1985)
    • Palmer, J.F.1
  • 82
    • 0032385802 scopus 로고    scopus 로고
    • Comparative risk assessment: Where does the public fit in?
    • Perhac, R.M. 1998. Comparative risk assessment: Where does the public fit in? Science, Technology, & Human Values 23:221-41.
    • (1998) Science, Technology, & Human Values , vol.23 , pp. 221-241
    • Perhac, R.M.1
  • 83
    • 34548164160 scopus 로고
    • Series editor's introduction
    • In edited by J.V. Pickstone Basingstoke: Macmillan
    • Pickstone, J.V. 1992. Series editor's introduction. In Medical innovations in historical perspective, edited by J.V. Pickstone, ix-x. Basingstoke: Macmillan.
    • (1992) Medical Innovations in Historical Perspective
    • Pickstone, J.V.1
  • 84
    • 33645564591 scopus 로고    scopus 로고
    • Hailing a miracle drug: The interferon
    • In edited by W. de Blecourt and C. Usborne. Basingstoke: Palgrave Macmillan
    • Pieters, T. 2004. Hailing a miracle drug: The interferon. In Cultural approaches to the history of medicine, edited by W. de Blecourt and C. Usborne. Basingstoke: Palgrave Macmillan.
    • (2004) Cultural Approaches to the History of Medicine
    • Pieters, T.1
  • 87
  • 90
    • 0344440086 scopus 로고
    • internal memorandum, 23 April. New Drug Application for indoprofen (END 0143). Washington, DC: Food and Drug Administration
    • Richman, D.J. 1984. Memorandum, internal memorandum, 23 April. New Drug Application for indoprofen (END 0143). Washington, DC: Food and Drug Administration.
    • (1984) Memorandum
    • Richman, D.J.1
  • 93
    • 6044267892 scopus 로고    scopus 로고
    • Failing the public health: Rofecoxib, Merck and the FDA
    • Topol, E.J. 2004. Failing the public health: Rofecoxib, Merck and the FDA. New England Journal of Medicine 351:1707-1709.
    • (2004) New England Journal of Medicine , vol.351 , pp. 1707-1709
    • Topol, E.J.1
  • 94
    • 34548173785 scopus 로고
    • US Congress. a Subcommittee of the Committee on Government Operations House of Representatives, August 3 and 4. Washington, DC: US Government Printing Office
    • US Congress. 1982. The regulation of new drugs by the Food and Drug Administration: The new drug review process. Hearing before a Subcommittee of the Committee on Government Operations House of Representatives, August 3 and 4. Washington, DC: US Government Printing Office.
    • (1982) The Regulation of New Drugs By the Food and Drug Administration: The New Drug Review Process Hearing Before
  • 95
    • 34548170807 scopus 로고
    • US Congress. Hearing of the Intergovernmental Relations and Human Resources Subcommittee of the House of Representatives, April 26 and 27. Washington, DC: US Government Printing Office
    • US Congress. 1983. FDA's regulation of Zomax. Hearing of the Intergovernmental Relations and Human Resources Subcommittee of the House of Representatives, April 26 and 27. Washington, DC: US Government Printing Office.
    • (1983) FDA's Regulation of Zomax
  • 96
    • 0034195047 scopus 로고    scopus 로고
    • Beyond skeptical relativism: Evaluating the social constructions of expert risk assessments
    • Van Zwanenberg, P., and E. Millstone. 2000. Beyond skeptical relativism: Evaluating the social constructions of expert risk assessments. Science, Technology, & Human Values 25:259-82.
    • (2000) Science, Technology, & Human Values , vol.25 , pp. 259-282
    • Van Zwanenberg, P.1    Millstone, E.2
  • 97
    • 0015237292 scopus 로고
    • Inhibition of prostaglandin synthesis as a mechanism for aspirin-like drugs
    • Vane, J.R. 1971. Inhibition of prostaglandin synthesis as a mechanism for aspirin-like drugs. Nature New Biology 231:232-5.
    • (1971) Nature New Biology , vol.231 , pp. 232-235
    • Vane, J.R.1
  • 99
    • 0000059810 scopus 로고
    • Reporting and under-reporting
    • In edited by R. D. Mann Lancashire: Parthenon
    • Walker, S.R., and C.E. Lumley. 1987. Reporting and under-reporting. In Adverse drug reactions, edited by R. D. Mann, 124-25. Lancashire: Parthenon.
    • (1987) Adverse Drug Reactions , pp. 124-125
    • Walker, S.R.1    Lumley, C.E.2
  • 100
    • 0015896840 scopus 로고
    • Introduction of new therapeutic drugs in the US and Great Britain: An international comparison
    • Wardell, W. 1973. Introduction of new therapeutic drugs in the US and Great Britain: An international comparison. Clinical Pharmacology and Therapeutics 14:773-90.
    • (1973) Clinical Pharmacology and Therapeutics , vol.14 , pp. 773-790
    • Wardell, W.1
  • 102
    • 0042972955 scopus 로고    scopus 로고
    • Emergent patterns in the regulation of pharmaceuticals: Institutions and interests in the US, Canada, Britain, and France
    • Wiktorowicz, M.E. 2003. Emergent patterns in the regulation of pharmaceuticals: Institutions and interests in the US, Canada, Britain, and France. Journal of Health, Politics, Policy and Law 28:615-58.
    • (2003) Journal of Health, Politics, Policy and Law , vol.28 , pp. 615-658
    • Wiktorowicz, M.E.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.