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Volumn , Issue , 2019, Pages 3-26

What is pharmacoepidemiology?

Author keywords

Adverse drug effects; Adverse drug reactions; Drug crises; Drug regulation; Pharmacoepidemiology; Postmarketing drug surveillance

Indexed keywords


EID: 85089640311     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781119413431.ch1     Document Type: Chapter
Times cited : (46)

References (188)
  • 1
    • 0032522873 scopus 로고    scopus 로고
    • Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies
    • Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200-5.
    • (1998) JAMA , vol.279 , pp. 1200-1205
    • Lazarou, J.1    Pomeranz, B.H.2    Corey, P.N.3
  • 2
    • 0022728614 scopus 로고
    • Increased risk of renal dysfunction due to interaction of liver disease and aminoglycosides
    • Moore RD, Smith CR, Lietman PS. Increased risk of renal dysfunction due to interaction of liver disease and aminoglycosides. Am J Med 1986; 80: 1093-7.
    • (1986) Am J Med , vol.80 , pp. 1093-1097
    • Moore, R.D.1    Smith, C.R.2    Lietman, P.S.3
  • 4
    • 0023723039 scopus 로고
    • Integrating pharmacoepidemiology into the design and conduct of clinical trials
    • Strom BL. Integrating pharmacoepidemiology into the design and conduct of clinical trials. J Clin Res Drug Dev 1988; 2: 161-8.
    • (1988) J Clin Res Drug Dev , vol.2 , pp. 161-168
    • Strom, B.L.1
  • 5
    • 84942481986 scopus 로고
    • Pathogenic effects of elixir of sulfanilimide (diethylene glycol) poisoning
    • Geiling EMK, Cannon PR. Pathogenic effects of elixir of sulfanilimide (diethylene glycol) poisoning. JAMA 1938; 111: 919-26.
    • (1938) JAMA , vol.111 , pp. 919-926
    • Geiling, E.M.K.1    Cannon, P.R.2
  • 8
    • 0008579705 scopus 로고
    • Detection and prevention of drug induced blood dyscrasias
    • Erslev AJ, Wintrobe MM. Detection and prevention of drug induced blood dyscrasias. JAMA 1962; 181: 114-19.
    • (1962) JAMA , vol.181 , pp. 114-119
    • Erslev, A.J.1    Wintrobe, M.M.2
  • 11
    • 0016385778 scopus 로고
    • Druginduced illness leading to hospitalization
    • Caranasos GJ, Stewart RB, Cluff LE. Druginduced illness leading to hospitalization. JAMA 1974; 228: 713-17.
    • (1974) JAMA , vol.228 , pp. 713-717
    • Caranasos, G.J.1    Stewart, R.B.2    Cluff, L.E.3
  • 12
    • 0013940249 scopus 로고
    • Malformations caused by drugs in pregnancy
    • Lenz W. Malformations caused by drugs in pregnancy. Am J Dis Child 1966; 112: 99-106.
    • (1966) Am J Dis Child , vol.112 , pp. 99-106
    • Lenz, W.1
  • 13
    • 0015972267 scopus 로고
    • Therapeutic implications of the drug lag
    • Wardell WM. Therapeutic implications of the drug lag. Clin Pharmacol Ther 1974; 15: 73-96.
    • (1974) Clin Pharmacol Ther , vol.15 , pp. 73-96
    • Wardell, W.M.1
  • 15
    • 0015225140 scopus 로고
    • Adenocarcinoma of the vagina: association of maternal stilbestrol therapy with tumor appearance in young women
    • Herbst AL, Ulfelder H, Poskanzer DC. Adenocarcinoma of the vagina: association of maternal stilbestrol therapy with tumor appearance in young women. N Engl J Med 1971; 284: 878-81.
    • (1971) N Engl J Med , vol.284 , pp. 878-881
    • Herbst, A.L.1    Ulfelder, H.2    Poskanzer, D.C.3
  • 16
    • 0016653881 scopus 로고
    • Untoward effects associated with practolol administration
    • Wright P. Untoward effects associated with practolol administration. Oculomucocutaneous syndrome. BMJ 1975; 1: 595-8.
    • (1975) Oculomucocutaneous syndrome. BMJ , vol.1 , pp. 595-598
    • Wright, P.1
  • 17
    • 0018841760 scopus 로고
    • FDA Drug Bull
    • Ticrynafen recalled. FDA Drug Bull 1980; 10: 3-4.
    • (1980) Ticrynafen recalled. , vol.10 , pp. 3-4
  • 18
    • 84888700656 scopus 로고
    • Suspension of benoxaprofen (Opren).
    • Suspension of benoxaprofen (Opren). BMJ 1982; 285: 519-20.
    • (1982) BMJ , vol.285 , pp. 519-520
  • 19
    • 0023572352 scopus 로고
    • The effect of indication on hypersensitivity reactions associated with zomepirac sodium and other nonsteroidal antiinflammatory drugs
    • Strom BL, Carson JL, Morse ML, West SL, Soper KA. The effect of indication on hypersensitivity reactions associated with zomepirac sodium and other nonsteroidal antiinflammatory drugs. Arthritis Rheum 1987; 30: 1142-8.
    • (1987) Arthritis Rheum , vol.30 , pp. 1142-1148
    • Strom, B.L.1    Carson, J.L.2    Morse, M.L.3    West, S.L.4    Soper, K.A.5
  • 20
    • 0017681747 scopus 로고
    • Study of fatal bone marrow depression with special reference to phenylbutazone and oxyphenbutazone
    • Inman WHW. Study of fatal bone marrow depression with special reference to phenylbutazone and oxyphenbutazone. BMJ 1977; 1: 1500-5.
    • (1977) BMJ , vol.1 , pp. 1500-1505
    • Inman, W.H.W.1
  • 21
    • 85102546030 scopus 로고
    • Osmosin (Controlled release indomethacin)
    • London
    • Committee on Safety of Medicines. Osmosin (Controlled release indomethacin). Current Problems, no. 11. London, 1983.
    • (1983) Current Problems , vol.11
  • 22
    • 0023598018 scopus 로고
    • The Bendectin saga: "Voluntary" discontinuation
    • Barash CI, Lasagna L. The Bendectin saga: "Voluntary" discontinuation. J Clin Res Drug Devel 1987; 1: 277-92.
    • (1987) J Clin Res Drug Devel , vol.1 , pp. 277-292
    • Barash, C.I.1    Lasagna, L.2
  • 23
    • 0024817450 scopus 로고
    • The epidemiology of the acute flank pain syndrome from suprofen
    • Strom BL, West SL, Sim E, Carson JL. The epidemiology of the acute flank pain syndrome from suprofen. Clin Pharmacol Ther 1989; 46: 693-9.
    • (1989) Clin Pharmacol Ther , vol.46 , pp. 693-699
    • Strom, B.L.1    West, S.L.2    Sim, E.3    Carson, J.L.4
  • 24
    • 0024283312 scopus 로고
    • FDA ponders approaches to curbing adverse effects of drug used against cystic acne. JAMA 1988; 259: 3225-30.
    • (1988) JAMA , vol.259 , pp. 3225-3230
  • 25
    • 0024516104 scopus 로고
    • When a uniquely effective drug is teratogenic: the case of isotretinoin
    • Stern RS. When a uniquely effective drug is teratogenic: the case of isotretinoin. N Engl J Med 1989; 320: 1007-9.
    • (1989) N Engl J Med , vol.320 , pp. 1007-1009
    • Stern, R.S.1
  • 27
    • 0009426510 scopus 로고
    • The triazolam experience in, in The Netherlands, a problem of signal generation and verification
    • New York: Plenum Press
    • Meyboom RHB. The triazolam experience in 1979 in The Netherlands, a problem of signal generation and verification. In: Strom BL, Velo GP, eds. Drug Epidemiology and Postmarketing Drug Surveillance. New York: Plenum Press, 1992, pp. 159-67.
    • (1979) Strom BL, Velo GP, eds. Drug Epidemiology and Postmarketing Drug Surveillance , vol.1992 , pp. 159-167
    • Meyboom, R.H.B.1
  • 28
    • 0001452425 scopus 로고
    • Triazolam's status in European Community
    • Triazolam's status in European Community. Lancet 1991; 338: 1586-7.
    • (1991) Lancet , vol.338 , pp. 1586-1587
  • 29
    • 0026002911 scopus 로고
    • Triazolam suspended
    • Brahams D. Triazolam suspended. Lancet 1991; 338: 938.
    • (1991) Lancet , vol.338 , pp. 938
    • Brahams, D.1
  • 30
    • 38249012242 scopus 로고
    • Triazolam hearing.
    • Triazolam hearing. Lancet 1992; 339: 1291.
    • (1992) Lancet , vol.339 , pp. 1291
  • 31
    • 0026680232 scopus 로고
    • Penile, testicular, other silicone implants soon will undergo FDA review (news)
    • Randall T. Penile, testicular, other silicone implants soon will undergo FDA review (news). JAMA 1992; 267: 2578-9.
    • (1992) JAMA , vol.267 , pp. 2578-2579
    • Randall, T.1
  • 32
    • 0025809794 scopus 로고
    • Risk of severe hypoglycaemia in insulin treated diabetic patients transferred to human insulin: a case control study
    • Egger M, Smith GD, Imhoof H, Teuscher A. Risk of severe hypoglycaemia in insulin treated diabetic patients transferred to human insulin: a case control study. BMJ 1991; 303: 617-21.
    • (1991) BMJ , vol.303 , pp. 617-621
    • Egger, M.1    Smith, G.D.2    Imhoof, H.3    Teuscher, A.4
  • 33
    • 0025812153 scopus 로고
    • Influence of human insulin on symptoms and awareness of hypoglycaemia: a randomised double blind crossover trial
    • Egger M, Smith GD, Teuscher AU, Teuscher A. Influence of human insulin on symptoms and awareness of hypoglycaemia: a randomised double blind crossover trial. BMJ 1991; 303: 622-6.
    • (1991) BMJ , vol.303 , pp. 622-626
    • Egger, M.1    Smith, G.D.2    Teuscher, A.U.3    Teuscher, A.4
  • 34
    • 0026749845 scopus 로고
    • Double-blind crossover comparison of human and porcine insulins in patients reporting lack of hypoglycaemia awareness
    • Colagiuri S, Miller JJ, Petocz P. Double-blind crossover comparison of human and porcine insulins in patients reporting lack of hypoglycaemia awareness. Lancet 1992; 339: 1432-5.
    • (1992) Lancet , vol.339 , pp. 1432-1435
    • Colagiuri, S.1    Miller, J.J.2    Petocz, P.3
  • 37
    • 0025012833 scopus 로고
    • Emergence of intense suicidal preoccupation during fluoxetine treatment
    • Teicher MH, Glod C, Cole JO. Emergence of intense suicidal preoccupation during fluoxetine treatment. Am J Psychiatry 1990; 147: 207-10.
    • (1990) Am J Psychiatry , vol.147 , pp. 207-210
    • Teicher, M.H.1    Glod, C.2    Cole, J.O.3
  • 38
    • 0025783404 scopus 로고
    • Fluoxetine and suicide: a meta-analysis of controlled trials of treatment for depression
    • Beasley CM, Dornseif BE, Bosomworth JC, et al. Fluoxetine and suicide: a meta-analysis of controlled trials of treatment for depression. BMJ 1991; 303: 685-92.
    • (1991) BMJ , vol.303 , pp. 685-692
    • Beasley, C.M.1    Dornseif, B.E.2    Bosomworth, J.C.3
  • 39
    • 0024515162 scopus 로고
    • Prescribed fenoterol and death from asthma in New Zealand, 1981-83: case-control study
    • Crane J, Pearce N, Flatt A, et al. Prescribed fenoterol and death from asthma in New Zealand, 1981-83: case-control study. Lancet 1989; 1: 917-22.
    • (1989) Lancet , vol.1 , pp. 917-922
    • Crane, J.1    Pearce, N.2    Flatt, A.3
  • 40
    • 0025318713 scopus 로고
    • Case-control study of prescribed fenoterol and death from asthma in New Zealand, 1977-81
    • Pearce N, Grainger J, Atkinson M, et al. Case-control study of prescribed fenoterol and death from asthma in New Zealand, 1977-81. Thorax 1990; 45: 170-5.
    • (1990) Thorax , vol.45 , pp. 170-175
    • Pearce, N.1    Grainger, J.2    Atkinson, M.3
  • 41
    • 0025797080 scopus 로고
    • Prescribed fenoterol and death from asthma in New Zealand, 1981-7: a further casecontrol study
    • Grainger J, Woodman K, Pearce N, et al. Prescribed fenoterol and death from asthma in New Zealand, 1981-7: a further casecontrol study. Thorax 1991; 46: 105-11.
    • (1991) Thorax , vol.46 , pp. 105-111
    • Grainger, J.1    Woodman, K.2    Pearce, N.3
  • 42
    • 0026595475 scopus 로고
    • The use of beta-agonists and the risk of death and near death from asthma
    • Spitzer WO, Suissa S, Ernst P, et al. The use of beta-agonists and the risk of death and near death from asthma. N Engl J Med 1992; 326:501-6.
    • (1992) N Engl J Med , vol.326 , pp. 501-506
    • Spitzer, W.O.1    Suissa, S.2    Ernst, P.3
  • 43
    • 84944656960 scopus 로고
    • The Food and Drug Administration and medroxyprogesterone acetate. What are the issues?
    • Rosenfield A, Maine D, Rochat R, Shelton J, Hatcher RA. The Food and Drug Administration and medroxyprogesterone acetate. What are the issues? JAMA 1983; 249: 2922-8.
    • (1983) JAMA , vol.249 , pp. 2922-2928
    • Rosenfield, A.1    Maine, D.2    Rochat, R.3    Shelton, J.4    Hatcher, R.A.5
  • 44
    • 0025781746 scopus 로고
    • Breast cancer and depot-medroxyprogesterone acetate: a multinational study
    • WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Breast cancer and depot-medroxyprogesterone acetate: a multinational study. Lancet 1991; 338:833-8.
    • (1991) Lancet , vol.338 , pp. 833-838
  • 45
    • 0026566509 scopus 로고
    • Depotmedroxyprogesterone acetate (DMPA) and risk of invasive squamous cell cervical cancer
    • WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Depotmedroxyprogesterone acetate (DMPA) and risk of invasive squamous cell cervical cancer. Contraception 1992; 45: 299-312.
    • (1992) Contraception , vol.45 , pp. 299-312
  • 46
    • 84948009828 scopus 로고
    • From the Food and Drug Administration: warnings issued on nonsedating antihistamines terfenadine and astemizole
    • Nightingale SL. From the Food and Drug Administration: warnings issued on nonsedating antihistamines terfenadine and astemizole. JAMA 1992; 268: 705.
    • (1992) JAMA , vol.268 , pp. 705
    • Nightingale, S.L.1
  • 47
    • 0026793695 scopus 로고
    • Antihistamines alert
    • Ahmad SR. Antihistamines alert. Lancet 1992; 340: 542.
    • (1992) Lancet , vol.340 , pp. 542
    • Ahmad, S.R.1
  • 49
    • 0025911491 scopus 로고
    • Bromocriptine and puerperal seizures
    • Gross TP. Bromocriptine and puerperal seizures. Epidemiology 1991; 2: 234-5.
    • (1991) Epidemiology , vol.2 , pp. 234-235
    • Gross, T.P.1
  • 50
    • 0027402794 scopus 로고
    • The withdrawal of temafloxacin: are there implications for other quinolones?
    • Finch RG. The withdrawal of temafloxacin: are there implications for other quinolones? Drug Saf 1993; 8: 9-11.
    • (1993) Drug Saf , vol.8 , pp. 9-11
    • Finch, R.G.1
  • 54
    • 0029132121 scopus 로고
    • Nifedipine: dose-related increase in mortality in patients with coronary heart disease
    • Furberg CD, Psaty BM, Meyer JV. Nifedipine: dose-related increase in mortality in patients with coronary heart disease. Circulation 1995; 92: 1326-31.
    • (1995) Circulation , vol.92 , pp. 1326-1331
    • Furberg, C.D.1    Psaty, B.M.2    Meyer, J.V.3
  • 55
    • 0030600342 scopus 로고    scopus 로고
    • Calcium-channel blockade and incidence of cancer in aged populations
    • Pahor M, Guralnik JM, Ferrucci L, et al. Calcium-channel blockade and incidence of cancer in aged populations. Lancet 1996; 348: 493-7.
    • (1996) Lancet , vol.348 , pp. 493-497
    • Pahor, M.1    Guralnik, J.M.2    Ferrucci, L.3
  • 56
    • 2042455581 scopus 로고    scopus 로고
    • Calcium antagonists and mortality in patients with coronary artery disease: a cohort study of 11, 575 patients
    • Braun S, Boyko V, Behar S, et al. Calcium antagonists and mortality in patients with coronary artery disease: a cohort study of 11, 575 patients. J Am Coll Cardiol 1996; 28: 7-11.
    • (1996) J Am Coll Cardiol , vol.28 , pp. 7-11
    • Braun, S.1    Boyko, V.2    Behar, S.3
  • 57
    • 0030989640 scopus 로고    scopus 로고
    • Association of calcium channel blocker use with increased rate of acute myocardial infarction in patients with left ventricular dysfunction
    • Kostis JB, Lacy CR, Cosgrove NM, Wilson AC. Association of calcium channel blocker use with increased rate of acute myocardial infarction in patients with left ventricular dysfunction. Am Heart J 1997; 133: 550-7.
    • (1997) Am Heart J , vol.133 , pp. 550-557
    • Kostis, J.B.1    Lacy, C.R.2    Cosgrove, N.M.3    Wilson, A.C.4
  • 59
  • 60
    • 0032054681 scopus 로고    scopus 로고
    • Calcium channel blockers and the risk of cancer
    • Rosenberg L, Rao RS, Palmer JR, et al. Calcium channel blockers and the risk of cancer. JAMA 1998; 279: 1000-4.
    • (1998) JAMA , vol.279 , pp. 1000-1004
    • Rosenberg, L.1    Rao, R.S.2    Palmer, J.R.3
  • 61
    • 0032212372 scopus 로고    scopus 로고
    • Calcium channel blockers, cancer incidence, and cancer mortality in a cohort of U.S
    • Michels KB, Rosner BA, Walker AM, et al. Calcium channel blockers, cancer incidence, and cancer mortality in a cohort of U.S. women: the Nurses' Health Study. Cancer 1998; 83: 2003-7.
    • (1998) women: the Nurses' Health Study. Cancer , vol.83 , pp. 2003-2007
    • Michels, K.B.1    Rosner, B.A.2    Walker, A.M.3
  • 62
    • 0029890375 scopus 로고    scopus 로고
    • Cisapride and fatal arrhythmia
    • Wysowski DK, Bacsanyi J. Cisapride and fatal arrhythmia. N Engl J Med 1996; 335: 290-1.
    • (1996) N Engl J Med , vol.335 , pp. 290-291
    • Wysowski, D.K.1    Bacsanyi, J.2
  • 63
    • 0032904146 scopus 로고    scopus 로고
    • Torsade de pointes induced by cisapride/clarithromycin interaction
    • Piquette RK. Torsade de pointes induced by cisapride/clarithromycin interaction. Ann Pharmacother 1999; 33: 22-6.
    • (1999) Ann Pharmacother , vol.33 , pp. 22-26
    • Piquette, R.K.1
  • 64
    • 0034694849 scopus 로고    scopus 로고
    • Contraindicated use of cisapride: impact of Food and Drug Administration regulatory action
    • Smalley W, Shatin D, Wysowski DK, et al. Contraindicated use of cisapride: impact of Food and Drug Administration regulatory action. JAMA 2000; 284: 3036-9.
    • (2000) JAMA , vol.284 , pp. 3036-3039
    • Smalley, W.1    Shatin, D.2    Wysowski, D.K.3
  • 65
    • 0034909358 scopus 로고    scopus 로고
    • Contraindicated medications dispensed with cisapride: temporal trends in relation to the sending of "Dear Doctor" letters
    • Weatherby LB, Walker AM, Fife D, Vervaet P, Klausner MA. Contraindicated medications dispensed with cisapride: temporal trends in relation to the sending of "Dear Doctor" letters. Pharmacoepidemiol Drug Saf 2001; 10: 211-18.
    • (2001) Pharmacoepidemiol Drug Saf , vol.10 , pp. 211-218
    • Weatherby, L.B.1    Walker, A.M.2    Fife, D.3    Vervaet, P.4    Klausner, M.A.5
  • 66
    • 0032055849 scopus 로고    scopus 로고
    • Aminorex, dexfenfluramine, and primary pulmonary hypertension
    • Kramer MS, Lane DA. Aminorex, dexfenfluramine, and primary pulmonary hypertension. J Clin Epidemiol 1998; 51: 361-4.
    • (1998) J Clin Epidemiol , vol.51 , pp. 361-364
    • Kramer, M.S.1    Lane, D.A.2
  • 67
    • 0030876952 scopus 로고    scopus 로고
    • Valvular heart disease associated with fenfluramine-phentermine
    • Connolly HM, Crary JL, McGoon MD, et al. Valvular heart disease associated with fenfluramine-phentermine. N Engl J Med 1997; 337: 581-8.
    • (1997) N Engl J Med , vol.337 , pp. 581-588
    • Connolly, H.M.1    Crary, J.L.2    McGoon, M.D.3
  • 68
    • 0033179867 scopus 로고    scopus 로고
    • Detailed examination of fenfluraminephentermine users with valve abnormalities identified in Fargo, North Dakota
    • Kimmel SE, Keane MG, Crary JL, et al. Detailed examination of fenfluraminephentermine users with valve abnormalities identified in Fargo, North Dakota. Am J Cardiol 1999; 84: 304-8.
    • (1999) Am J Cardiol , vol.84 , pp. 304-308
    • Kimmel, S.E.1    Keane, M.G.2    Crary, J.L.3
  • 69
    • 0030032413 scopus 로고    scopus 로고
    • Parenteral ketorolac and risk of gastrointestinal and operative site bleeding: a postmarketing surveillance study
    • Strom BL, Berlin JA, Kinman JL, et al. Parenteral ketorolac and risk of gastrointestinal and operative site bleeding: a postmarketing surveillance study. JAMA 1996; 275: 376-82.
    • (1996) JAMA , vol.275 , pp. 376-382
    • Strom, B.L.1    Berlin, J.A.2    Kinman, J.L.3
  • 70
    • 0031053255 scopus 로고    scopus 로고
    • Parenteral ketorolac: the risk for acute renal failure
    • Feldman HI, Kinman JL, Berlin JA, et al. Parenteral ketorolac: the risk for acute renal failure. Ann Intern Med 1997; 126: 193-9.
    • (1997) Ann Intern Med , vol.126 , pp. 193-199
    • Feldman, H.I.1    Kinman, J.L.2    Berlin, J.A.3
  • 71
    • 0030692852 scopus 로고    scopus 로고
    • Lack of hepatotoxic effects of parenteral ketorolac in the hospital setting
    • Hennessy S, Kinman JL, Berlin JA, et al. Lack of hepatotoxic effects of parenteral ketorolac in the hospital setting. Arch Intern Med 1997; 157: 2510-14.
    • (1997) Arch Intern Med , vol.157 , pp. 2510-2514
    • Hennessy, S.1    Kinman, J.L.2    Berlin, J.A.3
  • 72
    • 0002656782 scopus 로고    scopus 로고
    • Risk of hospitalization for upper gastrointestinal tract bleeding associated with ketorolac, other nonsteroidal anti-inflammatory drugs, calcium antagonists, and other antihypertensive drugs
    • Garcia Rodriguez LA, Cattaruzzi C, Troncon MG, Agostinis L. Risk of hospitalization for upper gastrointestinal tract bleeding associated with ketorolac, other nonsteroidal anti-inflammatory drugs, calcium antagonists, and other antihypertensive drugs. Arch Intern Med 1998; 158: 33-9.
    • (1998) Arch Intern Med , vol.158 , pp. 33-39
    • Garcia Rodriguez, L.A.1    Cattaruzzi, C.2    Troncon, M.G.3    Agostinis, L.4
  • 73
    • 0032496879 scopus 로고    scopus 로고
    • Life-threatening interaction of mibefradil and beta-blockers with dihydropyridine calcium channel blockers
    • Mullins ME, Horowitz BZ, Linden DH, Smith GW, Norton RL, Stump J. Life-threatening interaction of mibefradil and beta-blockers with dihydropyridine calcium channel blockers. JAMA 1998; 280: 157-8.
    • (1998) JAMA , vol.280 , pp. 157-158
    • Mullins, M.E.1    Horowitz, B.Z.2    Linden, D.H.3    Smith, G.W.4    Norton, R.L.5    Stump, J.6
  • 74
    • 0029671042 scopus 로고    scopus 로고
    • Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study
    • Spitzer WO, Lewis MA, Heinemann LA, Thorogood M, MacRae KD. Third generation oral contraceptives and risk of venous thromboembolic disorders: an international case-control study. BMJ 1996; 312: 83-8.
    • (1996) BMJ , vol.312 , pp. 83-88
    • Spitzer, W.O.1    Lewis, M.A.2    Heinemann, L.A.3    Thorogood, M.4    MacRae, K.D.5
  • 75
    • 0029586002 scopus 로고
    • Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components
    • Jick H, Jick SS, Gurewich V, Myers MW, Vasilakis C. Risk of idiopathic cardiovascular death and nonfatal venous thromboembolism in women using oral contraceptives with differing progestagen components. Lancet 1995; 346: 1589-93.
    • (1995) Lancet , vol.346 , pp. 1589-1593
    • Jick, H.1    Jick, S.S.2    Gurewich, V.3    Myers, M.W.4    Vasilakis, C.5
  • 76
    • 0031610077 scopus 로고    scopus 로고
    • Cardiovascular Disease and Steroid Hormone Contraception
    • WHO Technical Report Series. Cardiovascular Disease and Steroid Hormone Contraception. Geneva: World Health Organization, 1998.
    • (1998) Geneva: World Health Organization
  • 77
    • 0032499460 scopus 로고    scopus 로고
    • Increased risk of cerebral venous sinus thrombosis with third-generation oral contraceptives
    • de Bruijn SF, Stam J, Vandenbroucke JP. Increased risk of cerebral venous sinus thrombosis with third-generation oral contraceptives. Lancet 1998; 351: 1404.
    • (1998) Lancet , vol.351 , pp. 1404
    • de Bruijn, S.F.1    Stam, J.2    Vandenbroucke, J.P.3
  • 79
  • 81
    • 0031840421 scopus 로고    scopus 로고
    • Adverse events associated with Vitamin K1: results of a worldwide postmarketing surveillance programme
    • Pereira SP, Williams R. Adverse events associated with Vitamin K1: results of a worldwide postmarketing surveillance programme. Pharmacoepidemiol Drug Saf 1998; 7: 173-82.
    • (1998) Pharmacoepidemiol Drug Saf , vol.7 , pp. 173-182
    • Pereira, S.P.1    Williams, R.2
  • 82
    • 0242278337 scopus 로고    scopus 로고
    • Troglitazone-associated hepatic failure
    • Misbin RI. Troglitazone-associated hepatic failure. Ann Intern Med 1999; 130: 330.
    • (1999) Ann Intern Med , vol.130 , pp. 330
    • Misbin, R.I.1
  • 83
    • 0032535749 scopus 로고    scopus 로고
    • Fatal hepatotoxicity associated with troglitazone
    • Vella A, de Groen PC, Dinneen SF. Fatal hepatotoxicity associated with troglitazone. Ann Intern Med 1998; 129: 1080.
    • (1998) Ann Intern Med , vol.129 , pp. 1080
    • Vella, A.1    de Groen, P.C.2    Dinneen, S.F.3
  • 84
    • 0032125137 scopus 로고    scopus 로고
    • Troglitazone-induced hepatic failure leading to liver transplantation: a case report
    • Neuschwander-Tetri BA, Isley WL, Oki JC, et al. Troglitazone-induced hepatic failure leading to liver transplantation: a case report. Ann Intern Med 1998; 129: 38-41.
    • (1998) Ann Intern Med , vol.129 , pp. 38-41
    • Neuschwander-Tetri, B.A.1    Isley, W.L.2    Oki, J.C.3
  • 85
    • 0032125406 scopus 로고    scopus 로고
    • Two cases of severe clinical and histologic hepatotoxicity associated with troglitazone
    • Gitlin N, Julie NL, Spurr CL, Lim KN, Juarbe HM. Two cases of severe clinical and histologic hepatotoxicity associated with troglitazone. Ann Intern Med 1998; 129: 36-8.
    • (1998) Ann Intern Med , vol.129 , pp. 36-38
    • Gitlin, N.1    Julie, N.L.2    Spurr, C.L.3    Lim, K.N.4    Juarbe, H.M.5
  • 86
    • 4344670663 scopus 로고    scopus 로고
    • Suspension of rotavirus vaccine after reports of intussusception-United States, 1999
    • Centers for Disease Control and Prevention. Suspension of rotavirus vaccine after reports of intussusception-United States, 1999. Morb Mortal Wkly Rep 2004; 53: 786-9.
    • (2004) Morb Mortal Wkly Rep , vol.53 , pp. 786-789
  • 87
    • 0037077917 scopus 로고    scopus 로고
    • Alosetron: a case study in regulatory capture, or a victory for patients' rights?
    • Moynihan R. Alosetron: a case study in regulatory capture, or a victory for patients' rights? BMJ 2002; 325: 592-5.
    • (2002) BMJ , vol.325 , pp. 592-595
    • Moynihan, R.1
  • 89
    • 0036181103 scopus 로고    scopus 로고
    • Rapacuronium redux
    • Schulman SR. Rapacuronium redux. Anesth Analg 2002; 94: 483-4.
    • (2002) Anesth Analg , vol.94 , pp. 483-484
    • Schulman, S.R.1
  • 90
    • 0035469324 scopus 로고    scopus 로고
    • Ziprasidone and the QTc interval: pharmacokinetic and pharmacodynamic considerations
    • Kelly DL, Love RC. Ziprasidone and the QTc interval: pharmacokinetic and pharmacodynamic considerations. Psychopharmacol Bull 2001; 35: 66-79.
    • (2001) Psychopharmacol Bull , vol.35 , pp. 66-79
    • Kelly, D.L.1    Love, R.C.2
  • 91
    • 0034700436 scopus 로고    scopus 로고
    • Phenylpropanolamine and the risk of hemorrhagic stroke
    • Kernan WN, Viscoli CM, Brass LM, et al. Phenylpropanolamine and the risk of hemorrhagic stroke. N Engl J Med 2000; 343: 1826-32.
    • (2000) N Engl J Med , vol.343 , pp. 1826-1832
    • Kernan, W.N.1    Viscoli, C.M.2    Brass, L.M.3
  • 92
    • 0037154759 scopus 로고    scopus 로고
    • Adverse event reports following vaccination for Lyme disease: December 1998-July 2000
    • Lathrop SL, Ball R, Haber P, et al. Adverse event reports following vaccination for Lyme disease: December 1998-July 2000. Vaccine 2002; 20: 1603-8.
    • (2002) Vaccine , vol.20 , pp. 1603-1608
    • Lathrop, S.L.1    Ball, R.2    Haber, P.3
  • 94
    • 0242380319 scopus 로고    scopus 로고
    • Myocarditis: the unexpected return of smallpox vaccine adverse events
    • Chen RT, Lane JM. Myocarditis: the unexpected return of smallpox vaccine adverse events. Lancet 2003; 362: 1345-6.
    • (2003) Lancet , vol.362 , pp. 1345-1346
    • Chen, R.T.1    Lane, J.M.2
  • 95
    • 6044267892 scopus 로고    scopus 로고
    • Failing the public health-rofecoxib, Merck, and the FDA
    • Topol EJ. Failing the public health-rofecoxib, Merck, and the FDA. N Engl J Med 2004; 351: 1707-9.
    • (2004) N Engl J Med , vol.351 , pp. 1707-1709
    • Topol, E.J.1
  • 96
    • 0036039326 scopus 로고    scopus 로고
    • The significance of QT interval in drug development
    • Shah RR. The significance of QT interval in drug development. Br J Clin Pharmacol 2002; 54: 188-202.
    • (2002) Br J Clin Pharmacol , vol.54 , pp. 188-202
    • Shah, R.R.1
  • 97
    • 85081148095 scopus 로고    scopus 로고
    • (accessed April 2019)
    • U.S. Food & Drug Administration. Drug Safety-Related Labeling Changes. http://www.fda.gov/Safety/MedWatch/SafetyInformation/Safety-RelatedDrugLabelingChanges/default.htm (accessed April 2019).
    • Drug Safety-Related Labeling Changes
  • 98
    • 85102546331 scopus 로고
    • FDA Drug Review: Postapproval Risks 1976-1985
    • April
    • United States Government Accountability Office. FDA Drug Review: Postapproval Risks 1976-1985. GAO/PEMD-90-15, April 1990, p. 24.
    • (1990) GAO/PEMD-90-15 , pp. 24
  • 100
    • 85102547969 scopus 로고    scopus 로고
    • Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process
    • March, (accessed April 2019)
    • United States Government Accountability Office. Drug Safety: Improvement Needed in FDA's Postmarket Decision-Making and Oversight Process. GAO-06-402. March 2006. http://www.gao.gov/new.items/d06402. pdf (accessed April 2019).
    • (2006) GAO-06-402
  • 102
    • 0015972267 scopus 로고
    • Therapeutic implications of the drug lag
    • Wardell WM. Therapeutic implications of the drug lag. Clin Pharmacol Ther 1974; 15(1): 73-96.
    • (1974) Clin Pharmacol Ther , vol.15 , Issue.1 , pp. 73-96
    • Wardell, W.M.1
  • 103
    • 84871486472 scopus 로고    scopus 로고
    • (accessed November 2010)
    • US Food & Drug Administration. Prescription Drug User Fee Act (PDUFA). http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm(accessed November 2010).
    • Prescription Drug User Fee Act (PDUFA)
  • 104
    • 22144470134 scopus 로고    scopus 로고
    • Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates
    • Berndt ER, Gottschalk AH, Philipson TJ, Strobeck MW. Industry funding of the FDA: effects of PDUFA on approval times and withdrawal rates. Nat Rev Drug Discov 2005; 4(7): 545-54.
    • (2005) Nat Rev Drug Discov , vol.4 , Issue.7 , pp. 545-554
    • Berndt, E.R.1    Gottschalk, A.H.2    Philipson, T.J.3    Strobeck, M.W.4
  • 105
    • 0033549087 scopus 로고    scopus 로고
    • The safety of newly approved medicines: do recent market removals mean there is a problem?
    • Friedman MA, Woodcock J, Lumpkin MM, Shuren JE, Hass AE, Thompson LJ. The safety of newly approved medicines: do recent market removals mean there is a problem? JAMA 1999; 281: 1728-34.
    • (1999) JAMA , vol.281 , pp. 1728-1734
    • Friedman, M.A.1    Woodcock, J.2    Lumpkin, M.M.3    Shuren, J.E.4    Hass, A.E.5    Thompson, L.J.6
  • 107
    • 84988543093 scopus 로고    scopus 로고
    • FDA drug review: the debate over safety, efficacy, and speed
    • Lurie P, Woodcock J, Kaitin KI. FDA drug review: the debate over safety, efficacy, and speed. Medical Crossfire 1999; 1: 52-60.
    • (1999) Medical Crossfire , vol.1 , pp. 52-60
    • Lurie, P.1    Woodcock, J.2    Kaitin, K.I.3
  • 108
    • 0032542251 scopus 로고    scopus 로고
    • Making medicines safer-the need for an independent drug safety board
    • Wood AJ, Stein CM, Woosley R. Making medicines safer-the need for an independent drug safety board. N Engl J Med 1998; 339: 1851-4.
    • (1998) N Engl J Med , vol.339 , pp. 1851-1854
    • Wood, A.J.1    Stein, C.M.2    Woosley, R.3
  • 109
  • 110
    • 85102540525 scopus 로고    scopus 로고
    • The Future of Drug Safety: Promoting and Protecting the Health of the Public
    • DC: National Academy of Sciences
    • Institute of Medicine Committee on the Assessment of the US Drug Safety System. The Future of Drug Safety: Promoting and Protecting the Health of the Public. Washington, DC: National Academy of Sciences, 2007.
    • (2007) Washington
  • 111
    • 85102540472 scopus 로고    scopus 로고
    • PDUFA IV fees will go to improve postmarket drug safety
    • (accessed April 2019)
    • FDAnews. PDUFA IV fees will go to improve postmarket drug safety. FDAnews Drug Daily Bulletin 2008; 5. http://www.fdanews.com/newsletter/article?articleId=106457&issueId=11559 (accessed April 2019).
    • (2008) FDAnews Drug Daily Bulletin , vol.5
  • 112
    • 84871072020 scopus 로고    scopus 로고
    • (accessed April 2019)
    • U.S. Food & Drug Administration. Food and Drug Administration Safety and Innovation Act (FDASIA). https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/default.htm (accessed April 2019).
    • Food and Drug Administration Safety and Innovation Act (FDASIA)
  • 113
    • 85102538845 scopus 로고    scopus 로고
    • (accessedApril 2019)
    • U.S. Food & Drug Administration. Generic Drug User Fee Amendments. https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm (accessedApril 2019).
    • Generic Drug User Fee Amendments.
  • 114
    • 85102540357 scopus 로고    scopus 로고
    • (accessed April 2019)
    • U.S. Food & Drug Admniistration. Biosimilar User Fee Act (BsUFA). https://www.fda.gov/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/default.htm(accessed April 2019).
    • Biosimilar User Fee Act (BsUFA)
  • 115
    • 85030445023 scopus 로고    scopus 로고
    • (accessed April 2019)
    • Congress.gov. H.R.6-21st Century Cures Act. https://www.congress.gov/bill/114thcongress/house-bill/6 (accessed April 2019).
    • H.R.6-21st Century Cures Act
  • 117
    • 50549207549 scopus 로고
    • Medical review of prescribing
    • Muller C. Medical review of prescribing. J Chronic Dis 1965; 18: 689-96.
    • (1965) J Chronic Dis , vol.18 , pp. 689-696
    • Muller, C.1
  • 118
    • 0014210017 scopus 로고
    • Prescribing of chloramphenicol in general practice
    • Meade TW. Prescribing of chloramphenicol in general practice. BMJ 1967; 1: 671-4.
    • (1967) BMJ , vol.1 , pp. 671-674
    • Meade, T.W.1
  • 119
    • 0014309944 scopus 로고
    • Personal factors as a cause of differences in prescribing by general practitioners
    • Joyce CRB, Last JM, Weatherall M. Personal factors as a cause of differences in prescribing by general practitioners. Br J Prev Soc Med 1968; 22: 170-7.
    • (1968) Br J Prev Soc Med , vol.22 , pp. 170-177
    • Joyce, C.R.B.1    Last, J.M.2    Weatherall, M.3
  • 120
    • 0014298381 scopus 로고
    • Outpatient drug prescribing related to clinic utilization in four New York City hospitals
    • Muller C. Outpatient drug prescribing related to clinic utilization in four New York City hospitals. Health Serv Res 1968; 3: 142-54.
    • (1968) Health Serv Res , vol.3 , pp. 142-154
    • Muller, C.1
  • 121
    • 0004417489 scopus 로고
    • Casecontrol surveillance of serious illnesses attributable to ambulatory drug use
    • Epidemiological Evaluation of Drugs. Littleton, MA: PSG
    • Slone D, Shapiro S, Miettinen OS. Casecontrol surveillance of serious illnesses attributable to ambulatory drug use. In: Colombo F, Shapiro S, Slone D, Tognoni G, eds. Epidemiological Evaluation of Drugs. Littleton, MA: PSG, 1977, pp. 59-82.
    • (1977) Colombo F, Shapiro S, Slone D, Tognoni G, eds , pp. 59-82
    • Slone, D.1    Shapiro, S.2    Miettinen, O.S.3
  • 122
    • 85102541676 scopus 로고
    • Final Report
    • DC: U.S. Government Printing Office
    • Joint Commission on Prescription Drug Use. Final Report. Washington, DC: U.S. Government Printing Office, 1980.
    • (1980) Washington
  • 123
    • 0022211730 scopus 로고
    • The Computerized Online Medicaid Analysis and Surveillance System: a new resource for post-marketing drug surveillance
    • Strom BL, Carson JL, Morse ML, Leroy AA. The Computerized Online Medicaid Analysis and Surveillance System: a new resource for post-marketing drug surveillance. Clin Pharmacol Ther 1985; 38: 359-64.
    • (1985) Clin Pharmacol Ther , vol.38 , pp. 359-364
    • Strom, B.L.1    Carson, J.L.2    Morse, M.L.3    Leroy, A.A.4
  • 124
    • 0021297101 scopus 로고
    • Prescription event monitoring
    • Inman WHW. Prescription event monitoring. Acta Med Scand Suppl 1984; 683: 119-26.
    • (1984) Acta Med Scand Suppl , vol.683 , pp. 119-126
    • Inman, W.H.W.1
  • 125
    • 0010749476 scopus 로고
    • Members of the ASCPT Pharmacoepidemiology Section. Position paper on the use of purported postmarketing drug surveillance studies for promotional purposes
    • Strom BL, Members of the ASCPT Pharmacoepidemiology Section. Position paper on the use of purported postmarketing drug surveillance studies for promotional purposes. Clin Pharmacol Ther 1990; 48: 598.
    • (1990) Clin Pharmacol Ther , vol.48 , pp. 598
    • Strom, B.L.1
  • 126
    • 10544229343 scopus 로고    scopus 로고
    • ISPE. Guidelines for good epidemiology practices for drug, device, and vaccine research in the United States
    • Andrews EA, Avorn J, Bortnichak EA, et al.; ISPE. Guidelines for good epidemiology practices for drug, device, and vaccine research in the United States. Pharmacoepidemiol Drug Saf 1996; 5: 333-8.
    • (1996) Pharmacoepidemiol Drug Saf , vol.5 , pp. 333-338
    • Andrews, E.A.1    Avorn, J.2    Bortnichak, E.A.3
  • 127
    • 39749089389 scopus 로고    scopus 로고
    • Guidelines for good pharmacoepidemiology practices (GPP)
    • ISPE. Guidelines for good pharmacoepidemiology practices (GPP). Pharmacoepidemiol Drug Saf 2008; 17: 200-8.
    • (2008) Pharmacoepidemiol Drug Saf , vol.17 , pp. 200-208
  • 128
    • 33750548434 scopus 로고    scopus 로고
    • Privacy issues in research using record linkage
    • Neutel CI. Privacy issues in research using record linkage. Pharmacoepidemiol Drug Saf 1997; 6: 367 -9.
    • (1997) Pharmacoepidemiol Drug Saf , vol.6 , pp. 367-369
    • Neutel, C.I.1
  • 129
    • 0030690056 scopus 로고    scopus 로고
    • The threat to medical-records research
    • Melton LJ III. The threat to medical-records research. N Engl J Med 1997; 337: 1466-70.
    • (1997) N Engl J Med , vol.337 , pp. 1466-1470
    • Melton, L.J.1
  • 130
    • 0032792609 scopus 로고    scopus 로고
    • Data privacy and confidentiality
    • Mann RD. Data privacy and confidentiality. Pharmacoepidemiol Drug Saf 1999; 8: 245.
    • (1999) Pharmacoepidemiol Drug Saf , vol.8 , pp. 245
    • Mann, R.D.1
  • 131
    • 0032812286 scopus 로고    scopus 로고
    • Data privacy, medical record confidentiality, and research in the interest of public health
    • Andrews EB. Data privacy, medical record confidentiality, and research in the interest of public health. Pharmacoepidemiol Drug Saf 1999; 8: 247-60.
    • (1999) Pharmacoepidemiol Drug Saf , vol.8 , pp. 247-260
    • Andrews, E.B.1
  • 132
    • 0032792052 scopus 로고    scopus 로고
    • The issue of data privacy and confidentiality in Europe-1998
    • Mann RD. The issue of data privacy and confidentiality in Europe-1998. Pharmacoepidemiol Drug Saf 1999; 8: 261-4.
    • (1999) Pharmacoepidemiol Drug Saf , vol.8 , pp. 261-264
    • Mann, R.D.1
  • 133
    • 0035986736 scopus 로고    scopus 로고
    • The need for a national infrastructure to improve the rational use of therapeutics
    • Califf RM. The need for a national infrastructure to improve the rational use of therapeutics. Pharmacoepidemiol Drug Saf 2002; 11: 319-27.
    • (2002) Pharmacoepidemiol Drug Saf , vol.11 , pp. 319-327
    • Califf, R.M.1
  • 134
    • 85102540181 scopus 로고    scopus 로고
    • H.R.1-Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Sec. 1013
    • (accessed April 2019)
    • Congress.gov. H.R.1-Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Sec. 1013. Research on Outcomes of Health Care Items and Services. https://www.congress.gov/bill/108th-congress/housebill/00001 (accessed April 2019).
    • Research on Outcomes of Health Care Items and Services
  • 135
    • 85102542602 scopus 로고    scopus 로고
    • The Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) research network (U19)
    • (accessed April 2019)
    • Agency for Healthcare Research and Quality. The Developing Evidence to Inform Decisions about Effectiveness (DEcIDE) research network (U19). 2013. https://grants.nih.gov/grants/guide/rfa-files/RFAHS-13-009.html (accessed April 2019).
    • (2013)
  • 136
    • 33847161854 scopus 로고    scopus 로고
    • To Err Is Human: Building a Safer Health System
    • DC: National Academies Press
    • Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System. Washington, DC: National Academies Press, 2000.
    • (2000) Washington
    • Kohn, L.T.1    Corrigan, J.M.2    Donaldson, M.S.3
  • 137
    • 0029066463 scopus 로고
    • Incidence of adverse drug events and potential adverse drug events: implications for prevention
    • Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA 1995; 274: 29-34.
    • (1995) JAMA , vol.274 , pp. 29-34
    • Bates, D.W.1    Cullen, D.J.2    Laird, N.3
  • 138
    • 0025924692 scopus 로고
    • Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I
    • Brennan TA, Leape LL, Laird NM, et al. Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N Engl J Med 1991; 324: 370-6.
    • (1991) N Engl J Med , vol.324 , pp. 370-376
    • Brennan, T.A.1    Leape, L.L.2    Laird, N.M.3
  • 139
    • 0031032055 scopus 로고    scopus 로고
    • Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality
    • Classen DC, Pestotnik SL, Evans R, Scott R, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients: excess length of stay, extra costs, and attributable mortality. JAMA 1997; 277: 301-6.
    • (1997) JAMA , vol.277 , pp. 301-306
    • Classen, D.C.1    Pestotnik, S.L.2    Evans, R.3    Scott, R.4    Lloyd, J.F.5    Burke, J.P.6
  • 140
    • 0031012726 scopus 로고    scopus 로고
    • The costs of adverse drug events in hospitalized patients
    • Bates DW, Spell N, Cullen DJ, et al. The costs of adverse drug events in hospitalized patients. JAMA 1997; 277: 307-11.
    • (1997) JAMA , vol.277 , pp. 307-311
    • Bates, D.W.1    Spell, N.2    Cullen, D.J.3
  • 141
    • 0032574258 scopus 로고    scopus 로고
    • Increase in US medication-error deaths between 1983 and 1993
    • Phillips DP, Christenfeld N, Glynn LM. Increase in US medication-error deaths between 1983 and 1993. Lancet 1998; 351: 643-4.
    • (1998) Lancet , vol.351 , pp. 643-644
    • Phillips, D.P.1    Christenfeld, N.2    Glynn, L.M.3
  • 142
    • 0032580641 scopus 로고    scopus 로고
    • Increase in US medicationerror deaths (letter)
    • Manasse HR. Increase in US medicationerror deaths (letter). Lancet 1998; 351: 1655.
    • (1998) Lancet , vol.351 , pp. 1655
    • Manasse, H.R.1
  • 143
    • 0032580641 scopus 로고    scopus 로고
    • Increase in US medication-error deaths (letter)
    • Ferner RE, Anton C. Increase in US medication-error deaths (letter). Lancet 1998; 351: 1655-6.
    • (1998) Lancet , vol.351 , pp. 1655-1656
    • Ferner, R.E.1    Anton, C.2
  • 144
    • 0032580604 scopus 로고    scopus 로고
    • Increase in US medication-error deaths (letter)
    • Rooney C. Increase in US medication-error deaths (letter). Lancet 1998; 351: 1656-7.
    • (1998) Lancet , vol.351 , pp. 1656-1657
    • Rooney, C.1
  • 145
    • 14644429243 scopus 로고    scopus 로고
    • Increase in US medication-error deaths (letter)
    • Phillips DP, Christenfeld N, Glynn LM. Increase in US medication-error deaths (letter). Lancet 1998; 351: 1657.
    • (1998) Lancet , vol.351 , pp. 1657
    • Phillips, D.P.1    Christenfeld, N.2    Glynn, L.M.3
  • 146
    • 0034608973 scopus 로고    scopus 로고
    • Deaths due to medical errors are exaggerated in the Institute of Medicine report
    • McDonald CJ, Weiner M, Hui SL. Deaths due to medical errors are exaggerated in the Institute of Medicine report. JAMA 2000; 284: 93-5.
    • (2000) JAMA , vol.284 , pp. 93-95
    • McDonald, C.J.1    Weiner, M.2    Hui, S.L.3
  • 147
    • 0034608839 scopus 로고    scopus 로고
    • Institute of Medicine error figures are not exaggerated
    • Leape LL. Institute of Medicine error figures are not exaggerated. JAMA 2000; 284: 95-7.
    • (2000) JAMA , vol.284 , pp. 95-97
    • Leape, L.L.1
  • 148
    • 0042093742 scopus 로고    scopus 로고
    • Estrogen plus progestin and the risk of coronary heart disease
    • Manson JE, Hsia J, Johnson KC, et al. Estrogen plus progestin and the risk of coronary heart disease. N Engl J Med 2003; 349: 523-34.
    • (2003) N Engl J Med , vol.349 , pp. 523-534
    • Manson, J.E.1    Hsia, J.2    Johnson, K.C.3
  • 149
    • 0037125379 scopus 로고    scopus 로고
    • Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial
    • Writing Group for the Women's Health Initiative Investigators. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results from the Women's Health Initiative randomized controlled trial. JAMA 2002; 288: 321-33.
    • (2002) JAMA , vol.288 , pp. 321-333
  • 150
    • 1642576185 scopus 로고    scopus 로고
    • The discrepancy between observational studies and randomized trials of menopausal hormone therapy: did expectations shape experience?
    • Col NF, Pauker SG. The discrepancy between observational studies and randomized trials of menopausal hormone therapy: did expectations shape experience? Ann Intern Med 2003; 139: 923-9.
    • (2003) Ann Intern Med , vol.139 , pp. 923-929
    • Col, N.F.1    Pauker, S.G.2
  • 151
    • 0036898962 scopus 로고    scopus 로고
    • Perspectives on the Women's Health Initiative trial of hormone replacement therapy
    • Grimes DA, Lobo RA. Perspectives on the Women's Health Initiative trial of hormone replacement therapy. Obstet Gynecol 2002; 100: 1344-53.
    • (2002) Obstet Gynecol , vol.100 , pp. 1344-1353
    • Grimes, D.A.1    Lobo, R.A.2
  • 152
    • 0037208854 scopus 로고    scopus 로고
    • Observational studies and randomized trials of hormone replacement therapy: what can we learn from them?
    • Whittemore AS, McGuire V. Observational studies and randomized trials of hormone replacement therapy: what can we learn from them? Epidemiology 2003; 14: 8-9.
    • (2003) Epidemiology , vol.14 , pp. 8-9
    • Whittemore, A.S.1    McGuire, V.2
  • 153
    • 0037208922 scopus 로고    scopus 로고
    • Larger lessons from the Women's Health Initiative
    • Piantadosi S. Larger lessons from the Women's Health Initiative. Epidemiology 2003; 14: 6-7.
    • (2003) Epidemiology , vol.14 , pp. 6-7
    • Piantadosi, S.1
  • 154
    • 85102539671 scopus 로고    scopus 로고
    • New Drug Approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints
    • (accessed April 2019)
    • United States Government Accountability Office. New Drug Approval: FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints. GAO Highlights, September 23, 2009. http://www.gao.gov/highlights/d09866high.pdf (accessed April 2019).
    • (2009) GAO Highlights, September 23
  • 155
    • 85102543164 scopus 로고    scopus 로고
    • Report to the President and Congress on Comparative Effectiveness Research
    • DC: US Department of Health and Human Services
    • Federal Coordinating Council for Comparative Effectiveness Research. Report to the President and Congress on Comparative Effectiveness Research. Washington, DC: US Department of Health and Human Services, 2009.
    • (2009) Washington
  • 156
    • 84873069274 scopus 로고    scopus 로고
    • (accessed April 2019)
    • National Institute for Health and Clinical Excellence. What We Do. http://www.nice.org.uk/aboutnice/whatwedo/what_we_do.jsp (accessed April 2019).
    • What We Do
  • 157
    • 0142121432 scopus 로고    scopus 로고
    • Trends in development and approval times for new therapeutics in the United States
    • Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2003;2(9): 695-702.
    • (2003) Nat Rev Drug Discov , vol.2 , Issue.9 , pp. 695-702
    • Reichert, J.M.1
  • 158
    • 77952254018 scopus 로고    scopus 로고
    • Overcoming Phase II attrition problem
    • Haberman AB. Overcoming Phase II attrition problem. Genet Eng Biotechn N 2009; 29: 1.
    • (2009) Genet Eng Biotechn N , vol.29 , pp. 1
    • Haberman, A.B.1
  • 159
    • 0346800634 scopus 로고    scopus 로고
    • Washington, DC:PhRMA
    • Pharmaceutical Research and Manufacturers of America (PhRMA). Pharmaceutical Industry Profile 2003. Washington, DC:PhRMA, 2003, p. 75.
    • (2003) Pharmaceutical Industry Profile 2003 , pp. 75
  • 160
    • 85102548413 scopus 로고    scopus 로고
    • Pharmaceutical Research and Manufacturers of America (PhRMA). Pharmaceutical Industry Profile 2009. Washington, DC: PhRMA, 2003, p. 2.
    • (2009) Washington, DC: PhRMA , vol.2003 , pp. 2
  • 161
    • 85102539345 scopus 로고    scopus 로고
    • Cost to bring drug to market: $802m
    • April 29, (accessed April 2019)
    • Shafrin J. Cost to bring drug to market: $802m. Healthcare Economist, April 29, 2006. http://healthcare-economist.com/2006/04/29/802m (accessed April 2019).
    • (2006) Healthcare Economist
    • Shafrin, J.1
  • 162
    • 61449238277 scopus 로고    scopus 로고
    • Drug development cost estimates hard to swallow
    • Collier R. Drug development cost estimates hard to swallow. CMAJ 2009; 180: 279-80.
    • (2009) CMAJ , vol.180 , pp. 279-280
    • Collier, R.1
  • 163
  • 164
    • 84876326795 scopus 로고    scopus 로고
    • (accessed April 2019)
    • Government of Canada. Health Canada. http://www.hc-sc.gc.ca/index-eng.php (accessed April 2019).
    • Health Canada
  • 165
    • 85102538854 scopus 로고    scopus 로고
    • (accessed April 2019)
    • China Food and Drug Administration. https://en.wikipedia.org/wiki/China_Food_and_Drug_Administration (accessed April 2019)
  • 166
    • 85102546762 scopus 로고    scopus 로고
    • (accessed April 2019)
    • Danish Medicines Agency. About Us. http://www.dkma.dk/1024/visUKLSForside.asp?artikelID=728 (accessed April 2019).
    • About Us
  • 167
    • 84935129121 scopus 로고    scopus 로고
    • (accessed April 2019)
    • Norwegian Medicines Agency. About Us. http://www.legemiddelverket.net/templates/InterPage____16645.aspx (accessed April 2019).
    • About Us.
  • 168
    • 85102544834 scopus 로고    scopus 로고
    • Update, (accessed April 2019)
    • Pacific Bridge Medical. Singapore's Pharmaceutical and Medical Device Regulatory Environment: 2005 Update. https://www.pacificbridgemedical.com/publication/singapore-8217-s-pharmaceutical-andmedical-device-regulatory-environment-2005-update (accessed April 2019).
    • (2005) Singapore's Pharmaceutical and Medical Device Regulatory Environment
  • 169
    • 85099232922 scopus 로고    scopus 로고
    • (accessed April 2019)
    • New Zealand Medicines and Medical Devices Safety Authority. About Medsafe. http://www.medsafe.govt.nz/other/about.asp(accessed April 2019).
    • About Medsafe
  • 170
    • 85102543189 scopus 로고    scopus 로고
    • (accessed April 2019)
    • Central Drugs Standard Control Organization. About CDSCO. https://cdsco.gov.in/opencms/opencms/en/Home (accessed April 2019).
    • About CDSCO.
  • 171
    • 84888676504 scopus 로고    scopus 로고
    • Pharmacopolitics: drug regulation in the United States and Germany
    • Reichert JM. Pharmacopolitics: drug regulation in the United States and Germany. N Engl J Med 2004; 350: 2220-1.
    • (2004) N Engl J Med , vol.350 , pp. 2220-2221
    • Reichert, J.M.1
  • 172
    • 84935129121 scopus 로고    scopus 로고
    • (accessed April 2019)
    • European Medicines Agency. About Us. https://www.ema.europa.eu/en/about-us (accessed April 2019).
    • About Us.
  • 173
    • 0032982963 scopus 로고    scopus 로고
    • Harmonising and competing for medicines regulation: how healthy are the European Union's systems of drug approval?
    • Abraham J, Lewis G. Harmonising and competing for medicines regulation: how healthy are the European Union's systems of drug approval? Soc Sci Med 1999; 48: 1655-67.
    • (1999) Soc Sci Med , vol.48 , pp. 1655-1667
    • Abraham, J.1    Lewis, G.2
  • 174
    • 84873069274 scopus 로고    scopus 로고
    • (accessed April 2019)
    • European Medicines Agency. What We Do. https://www.ema.europa.eu/en/about-us/what-we-do (accessed April 2019).
    • What We Do
  • 175
    • 85102542124 scopus 로고    scopus 로고
    • Philadelphia, PA: OIG. May, (accessed April 2019)
    • Department of Health and Human Services, Office of Inspector General. Postmarketing Studies of Prescription Drugs. OEI-03-94-00760. Philadelphia, PA: OIG. May 1996, p. 11. http://oig.hhs.gov/oei/reports/oei-03-94-00760.pdf (accessed April 2019).
    • (1996) Postmarketing Studies of Prescription Drugs. OEI-03-94-00760. , pp. 11
  • 176
    • 0017179357 scopus 로고
    • Prazosin: severe side effects are dose-dependent
    • Rosendorff C. Prazosin: severe side effects are dose-dependent. BMJ 1976; 2: 508.
    • (1976) BMJ , vol.2 , pp. 508
    • Rosendorff, C.1
  • 178
    • 84985266606 scopus 로고
    • Case studies of expedited review: AZT and L-Dopa
    • Kaitin KI. Case studies of expedited review: AZT and L-Dopa. Law Med Health Care 1991; 19: 242-6.
    • (1991) Law Med Health Care , vol.19 , pp. 242-246
    • Kaitin, K.I.1
  • 180
    • 0042370346 scopus 로고    scopus 로고
    • Postmarketing drug dosage changes
    • Peck CC. Postmarketing drug dosage changes. Pharmacoepidemiol Drug Saf 2003;12: 425-6.
    • (2003) Pharmacoepidemiol Drug Saf , vol.12 , pp. 425-426
    • Peck, C.C.1
  • 183
    • 0017408539 scopus 로고
    • Drug interactions and multiple drug administration
    • May FE, Stewart RB, Cluff LE. Drug interactions and multiple drug administration. Clin Pharmacol Ther 1977; 22: 322-8.
    • (1977) Clin Pharmacol Ther , vol.22 , pp. 322-328
    • May, F.E.1    Stewart, R.B.2    Cluff, L.E.3
  • 184
    • 0023009494 scopus 로고
    • Adverse respiratory and cardiovascular events attributed to timolol ophthalmic solution, 1978-1985
    • Nelson WL, Fraunfelder FT, Sills JM, Arrowsmith JB, Kuritsky JN. Adverse respiratory and cardiovascular events attributed to timolol ophthalmic solution, 1978-1985. Am J Ophthalmol 1986; 102: 606-11.
    • (1986) Am J Ophthalmol , vol.102 , pp. 606-611
    • Nelson, W.L.1    Fraunfelder, F.T.2    Sills, J.M.3    Arrowsmith, J.B.4    Kuritsky, J.N.5
  • 185
    • 0022508895 scopus 로고
    • Risks of agranulocytosis and aplastic anemia: a first report of their relation to drug use with special reference to analgesics
    • International Agranulocytosis and Aplastic Anemia Study. Risks of agranulocytosis and aplastic anemia: a first report of their relation to drug use with special reference to analgesics. JAMA 1986; 256: 1749-57.
    • (1986) JAMA , vol.256 , pp. 1749-1757
  • 186
    • 0016280717 scopus 로고
    • Epidemiology of acute drug intoxications: patient characteristics, drugs, and medical complications
    • Stewart RB, Forgnone M, May FE, Forbes J, Cluff LE. Epidemiology of acute drug intoxications: patient characteristics, drugs, and medical complications. Clin Toxicol 1974; 7: 513-30.
    • (1974) Clin Toxicol , vol.7 , pp. 513-530
    • Stewart, R.B.1    Forgnone, M.2    May, F.E.3    Forbes, J.4    Cluff, L.E.5
  • 187
    • 0021525476 scopus 로고
    • New drugs and clinical economics: analysis of cost-effectiveness analysis in the assessment of pharmaceutical innovations
    • Eisenberg JM. New drugs and clinical economics: analysis of cost-effectiveness analysis in the assessment of pharmaceutical innovations. Rev Infect Dis 1984; 6(Suppl 4): 905-8.
    • (1984) Rev Infect Dis , vol.6 , pp. 905-908
    • Eisenberg, J.M.1
  • 188
    • 84972760831 scopus 로고
    • Reducing drug therapyinduced hospitalization: impact of drug utilization review
    • Morse ML, Leroy AA, Gaylord TA, Kellenberger T. Reducing drug therapyinduced hospitalization: impact of drug utilization review. Drug Inf J 1982; 16: 199-202.
    • (1982) Drug Inf J , vol.16 , pp. 199-202
    • Morse, M.L.1    Leroy, A.A.2    Gaylord, T.A.3    Kellenberger, T.4


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