메뉴 건너뛰기




Volumn 132, Issue 9, 2000, Pages 715-722

Claims of equivalence in medical research: Are they supported by the evidence?

Author keywords

[No Author keywords available]

Indexed keywords

ALTEPLASE;

EID: 0034595229     PISSN: 00034819     EISSN: None     Source Type: Journal    
DOI: 10.7326/0003-4819-132-9-200005020-00006     Document Type: Article
Times cited : (146)

References (41)
  • 1
    • 0030894813 scopus 로고    scopus 로고
    • Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism
    • Dong BJ, Hauck WW, Gambertoglio JG, Gee L, White JR, Bubp JL, et al. Bioequivalence of generic and brand-name levothyroxine products in the treatment of hypothyroidism. JAMA. 1997;277:1205-13.
    • (1997) JAMA , vol.277 , pp. 1205-1213
    • Dong, B.J.1    Hauck, W.W.2    Gambertoglio, J.G.3    Gee, L.4    White, J.R.5    Bubp, J.L.6
  • 3
    • 0027077457 scopus 로고
    • Low-dose radiation therapy and reduced chemotherapy in childhood Hodgkin's disease: The experience of the French Society of Pediatric Oncology
    • Oberlin O, Leverger G, Pacquement H, Raquin MA, Chompret A, Habrand JL, et al. Low-dose radiation therapy and reduced chemotherapy in childhood Hodgkin's disease: the experience of the French Society of Pediatric Oncology. J Clin Oncol. 1992;10:1602-8.
    • (1992) J Clin Oncol. , vol.10 , pp. 1602-1608
    • Oberlin, O.1    Leverger, G.2    Pacquement, H.3    Raquin, M.A.4    Chompret, A.5    Habrand, J.L.6
  • 4
    • 0029900724 scopus 로고    scopus 로고
    • Larynx preservation in pyriform sinus cancer: Preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group
    • Lefebvre JL, Chevalier D, Luboinski B, Kirkpatrick A, Collette L, Sahmoud T. Larynx preservation in pyriform sinus cancer: preliminary results of a European Organization for Research and Treatment of Cancer phase III trial. EORTC Head and Neck Cancer Cooperative Group. J Natl Cancer Inst. 1996; 88:890-9.
    • (1996) J Natl Cancer Inst. , vol.88 , pp. 890-899
    • Lefebvre, J.L.1    Chevalier, D.2    Luboinski, B.3    Kirkpatrick, A.4    Collette, L.5    Sahmoud, T.6
  • 5
    • 0029043963 scopus 로고
    • GR106642X: A new, non-ozone depleting propellant for inhalers
    • Taggart SC, Custovic A, Richards DH, Woodcock A. GR106642X: a new, non-ozone depleting propellant for inhalers. BMJ. 1995;310:1639-40.
    • (1995) BMJ , vol.310 , pp. 1639-1640
    • Taggart, S.C.1    Custovic, A.2    Richards, D.H.3    Woodcock, A.4
  • 6
    • 84971580244 scopus 로고
    • Absence of evidence is not evidence of absence
    • Altman DG, Bland JM. Absence of evidence is not evidence of absence. BMJ. 1995;311:485.
    • (1995) BMJ , vol.311 , pp. 485
    • Altman, D.G.1    Bland, J.M.2
  • 7
    • 0029987569 scopus 로고    scopus 로고
    • Trials to assess equivalence: The importance of rigorous methods
    • Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36-9.
    • (1996) BMJ , vol.313 , pp. 36-39
    • Jones, B.1    Jarvis, P.2    Lewis, J.A.3    Ebbutt, A.F.4
  • 8
    • 0018484431 scopus 로고
    • When can 'non significantly different' treatments be considered as 'equivalent'?
    • Spriet A, Beiler D. When can 'non significantly different' treatments be considered as 'equivalent'? Br J Clin Pharmacol. 1979;7:623-4.
    • (1979) Br J Clin Pharmacol. , vol.7 , pp. 623-624
    • Spriet, A.1    Beiler, D.2
  • 10
    • 0029887822 scopus 로고    scopus 로고
    • Once-daily aminoglycoside dosing in immunocompetent adults: A meta-analysis
    • Hatala R, Dinh T, Cook DJ. Once-daily aminoglycoside dosing in immunocompetent adults: a meta-analysis. Ann Intern Med. 1996;124:717-25.
    • (1996) Ann Intern Med. , vol.124 , pp. 717-725
    • Hatala, R.1    Dinh, T.2    Cook, D.J.3
  • 11
    • 0028070312 scopus 로고
    • Therapeutic interchange of fluoxetine and sertraline: Experience in the clinical setting
    • Stock AJ, Kofoed L. Therapeutic interchange of fluoxetine and sertraline: experience in the clinical setting. Am J Hosp Pharm. 1994;51:2279-81.
    • (1994) Am J Hosp Pharm. , vol.51 , pp. 2279-2281
    • Stock, A.J.1    Kofoed, L.2
  • 12
    • 0027070827 scopus 로고
    • Functionally relevant gamma-aminobutyric acid A receptors: Equivalence between receptor affinity (Kd) and potency (EC50)?
    • Edgar PP, Schwartz RD. Functionally relevant gamma-aminobutyric acid A receptors: equivalence between receptor affinity (Kd) and potency (EC50)? Mol Pharmacol. 1992;41:1124-9.
    • (1992) Mol Pharmacol. , vol.41 , pp. 1124-1129
    • Edgar, P.P.1    Schwartz, R.D.2
  • 13
    • 0027095964 scopus 로고
    • Bioavailability of a new controlled-release oral naproxen formulation given with and without food
    • Palazzini M, Cristofori M, Babbini M. Bioavailability of a new controlled-release oral naproxen formulation given with and without food. Int J Clin Pharmacol Res. 1992;12:179-84.
    • (1992) Int J Clin Pharmacol Res. , vol.12 , pp. 179-184
    • Palazzini, M.1    Cristofori, M.2    Babbini, M.3
  • 16
    • 0030814329 scopus 로고    scopus 로고
    • Equivalence trials
    • Ware JH, Antman EM. Equivalence trials [Editorial]. N Engl J Med. 1997; 337:1159-61.
    • (1997) N Engl J Med. , vol.337 , pp. 1159-1161
    • Ware, J.H.1    Antman, E.M.2
  • 17
    • 0024638447 scopus 로고
    • Effect sizes for interpreting changes in health status
    • Kazis LE, Anderson JJ, Meenan RF. Effect sizes for interpreting changes in health status. Med Care. 1989;27:S178-S189.
    • (1989) Med Care , vol.27
    • Kazis, L.E.1    Anderson, J.J.2    Meenan, R.F.3
  • 18
    • 0018076475 scopus 로고
    • The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial
    • Freiman JA, Chalmers TC, Smith H, Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial. N Engl J Med. 1978;299:690-4.
    • (1978) N Engl J Med. , vol.299 , pp. 690-694
    • Freiman, J.A.1    Chalmers, T.C.2    Smith, H.3    Kuebler, R.R.4
  • 19
    • 0343110392 scopus 로고    scopus 로고
    • National Library of Medicine Abridged Index Medicus. v 28. Washington, DC: U.S. Department of Health and Human Services; 1997.
    • National Library of Medicine Abridged Index Medicus. v 28. Washington, DC: U.S. Department of Health and Human Services; 1997.
  • 20
    • 0027087116 scopus 로고
    • Therapeutic equivalence of a fenoterol/ipratropium bromide combination (Berodual) inhaled as a dry powder and by metered dose inhaler in chronic obstructive airway disease
    • Rammeloo RH, Luursema PB, Sips AP, Beumer HM, Wald FD, Cornelissen PJ. Therapeutic equivalence of a fenoterol/ipratropium bromide combination (Berodual) inhaled as a dry powder and by metered dose inhaler in chronic obstructive airway disease. Respiration. 1992;59:322-6.
    • (1992) Respiration , vol.59 , pp. 322-326
    • Rammeloo, R.H.1    Luursema, P.B.2    Sips, A.P.3    Beumer, H.M.4    Wald, F.D.5    Cornelissen, P.J.6
  • 21
    • 0026612957 scopus 로고
    • A comparison of circulating hormone levels in postmenopausal women receiving hormone replacement therapy
    • Jurgens RW, Downey LJ, Abernethy WD, Cutler NR, Conrad J. A comparison of circulating hormone levels in postmenopausal women receiving hormone replacement therapy. Am J Obstet Gynecol. 1992;167:459-60.
    • (1992) Am J Obstet Gynecol. , vol.167 , pp. 459-460
    • Jurgens, R.W.1    Downey, L.J.2    Abernethy, W.D.3    Cutler, N.R.4    Conrad, J.5
  • 22
    • 0027731044 scopus 로고
    • Cefepime versus cefotaxime in the treatment of lower respiratory tract infections
    • Barckow D, Schwigon CD. Cefepime versus cefotaxime in the treatment of lower respiratory tract infections. J Antimicrob Chemother. 1993;32:187-93.
    • (1993) J Antimicrob Chemother. , vol.32 , pp. 187-193
    • Barckow, D.1    Schwigon, C.D.2
  • 23
    • 0029119427 scopus 로고
    • Deflazacort versus methylprednisolone in polymyalgia rheumatica: Clinical equivalence and relative antiinflammatory potency of different treatment regimens
    • Di Munno O, Imbimbo B, Mazzantini M, Milani S, Occhipinti G, Pasero G. Deflazacort versus methylprednisolone in polymyalgia rheumatica: clinical equivalence and relative antiinflammatory potency of different treatment regimens. J Rheumatol. 1995;22:1492-8.
    • (1995) J Rheumatol. , vol.22 , pp. 1492-1498
    • Di Munno, O.1    Imbimbo, B.2    Mazzantini, M.3    Milani, S.4    Occhipinti, G.5    Pasero, G.6
  • 24
    • 0029999825 scopus 로고    scopus 로고
    • Subcutaneous low-molecular-weight heparin versus standard heparin and the prevention of thromboembolisnn in medical inpatients
    • Harenberg J, Roebruck P, Heene DL. Subcutaneous low-molecular-weight heparin versus standard heparin and the prevention of thromboembolisnn in medical inpatients. Haemostasis. 1996;26:127-39.
    • (1996) Haemostasis. , vol.26 , pp. 127-139
    • Harenberg, J.1    Roebruck, P.2    Heene, D.L.3
  • 25
    • 0029142436 scopus 로고
    • Randomised, double-blind comparison of reteplase double-bolus administration with streptokinase in acute myocardial infarction: Trial to investigate equivalence. International joint efficacy comparison of thrombolytics
    • Randomised, double-blind comparison of reteplase double-bolus administration with streptokinase in acute myocardial infarction: trial to investigate equivalence. International Joint Efficacy Comparison of Thrombolytics. Lancet. 1995;346:329-36.
    • (1995) Lancet , vol.346 , pp. 329-336
  • 26
    • 0028789047 scopus 로고
    • A randomized comparison of the effect of four antihypertensive monotherapies on the subjective quality of life in previously untreated asymptomatic patients: Field trial in general practice. The OCAPI study group optimiser le choix d'un anti-hypertenseur de premiere intention
    • Boissel JP, Collet JP, Lion L, Ducruet T, Moleur P, Luciani J, et al. A randomized comparison of the effect of four antihypertensive monotherapies on the subjective quality of life in previously untreated asymptomatic patients: field trial in general practice. The OCAPI Study Group Optimiser le Choix d'un Anti-hypertenseur de Premiere Intention. J Hypertens. 1995;13:1059-67.
    • (1995) J Hypertens , vol.13 , pp. 1059-1067
    • Boissel, J.P.1    Collet, J.P.2    Lion, L.3    Ducruet, T.4    Moleur, P.5    Luciani, J.6
  • 28
    • 0017643592 scopus 로고
    • Significance testing to establish equivalence between treatments, with special reference to data in the form of 2×2 tables
    • Dunnett CW, Gent M. Significance testing to establish equivalence between treatments, with special reference to data in the form of 2×2 tables. Biometrics. 1977;33:593-602.
    • (1977) Biometrics , vol.33 , pp. 593-602
    • Dunnett, C.W.1    Gent, M.2
  • 29
    • 0016817841 scopus 로고
    • Clinical biostatistics. XXXIV. The other side of "statistical significance": Alpha, beta, delta, and the calculation of sample size
    • Feinstein AR. Clinical biostatistics. XXXIV. The other side of "statistical significance": alpha, beta, delta, and the calculation of sample size. Clin Pharmacol Ther. 1975;18:491-505.
    • (1975) Clin Pharmacol Ther. , vol.18 , pp. 491-505
    • Feinstein, A.R.1
  • 30
    • 0018103242 scopus 로고
    • Sample size requirements for evaluating a conservative therapy
    • Makuch R, Simon R. Sample size requirements for evaluating a conservative therapy. Cancer Treat Rep. 1978;62:1037-40.
    • (1978) Cancer Treat Rep. , vol.62 , pp. 1037-1040
    • Makuch, R.1    Simon, R.2
  • 31
    • 0023615056 scopus 로고
    • A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability
    • Schuirmann DJ. A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm. 1987;15:657-80.
    • (1987) J Pharmacokinet Biopharm. , vol.15 , pp. 657-680
    • Schuirmann, D.J.1
  • 32
    • 0029125802 scopus 로고
    • Assessing equivalence of inhaled drugs
    • Fuller RW, Hallett C, Dahl R. Assessing equivalence of inhaled drugs. Respir Med. 1995;89:525-7.
    • (1995) Respir Med. , vol.89 , pp. 525-527
    • Fuller, R.W.1    Hallett, C.2    Dahl, R.3
  • 33
    • 0029006762 scopus 로고
    • Bayesian predictive approach for inference about proportions
    • Lecoutre B, Derzko G, Grouin JM. Bayesian predictive approach for inference about proportions. Stat Med. 1995;14:1057-63.
    • (1995) Stat Med. , vol.14 , pp. 1057-1063
    • Lecoutre, B.1    Derzko, G.2    Grouin, J.M.3
  • 34
    • 0002092642 scopus 로고
    • General approaches to the problem of bioequivalence
    • O'Quigley J, Baudoin C. General approaches to the problem of bioequivalence. The Statistician. 1988;37:51-8.
    • (1988) The Statistician , vol.37 , pp. 51-58
    • O'Quigley, J.1    Baudoin, C.2
  • 35
    • 0031860230 scopus 로고    scopus 로고
    • Zeta and delta: Critical descriptive boundaries in statistical analysis
    • Feinstein AR. Zeta and delta: critical descriptive boundaries in statistical analysis. J Clin Epidemiol. 1998;51:527-30.
    • (1998) J Clin Epidemiol. , vol.51 , pp. 527-530
    • Feinstein, A.R.1
  • 36
    • 0029155045 scopus 로고
    • Moclobemide versus clomipramine in depressed patients in general practice. A randomized, double-blind, parallel, multicenter study
    • Kragh-Sorensen P, Muller B, Andersen JV, Buch D, Stage KB. Moclobemide versus clomipramine in depressed patients in general practice. A randomized, double-blind, parallel, multicenter study. J Clin Psychopharmacol. 1995;15:24S-30S.
    • (1995) J Clin Psychopharmacol. , vol.15
    • Kragh-Sorensen, P.1    Muller, B.2    Andersen, J.V.3    Buch, D.4    Stage, K.B.5
  • 37
    • 0027240597 scopus 로고
    • An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. The GUSTO investigators
    • An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. The GUSTO investigators. N Engl J Med. 1993; 329:673-82.
    • (1993) N Engl J Med. , vol.329 , pp. 673-682
  • 38
    • 0030847845 scopus 로고    scopus 로고
    • A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction. The continuous infusion versus Double-Bolus Administration of Alteplase (COBALT) investigators
    • A comparison of continuous infusion of alteplase with double-bolus administration for acute myocardial infarction. The Continuous Infusion versus double-bolus administration of Alteplase (COBALT) Investigators. N Engl J Med. 1997;337:1124-30.
    • (1997) N Engl J Med. , vol.337 , pp. 1124-1130
  • 39
    • 0033612881 scopus 로고    scopus 로고
    • Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: The ASSENT-2 double-blind randomised trial. Assessment of the safety and efficacy of a new thrombolytic investigators
    • Single-bolus tenecteplase compared with front-loaded alteplase in acute myocardial infarction: the ASSENT-2 double-blind randomised trial. Assessment of the Safety and Efficacy of a New Thrombolytic Investigators. Lancet. 1999; 354:716-22.
    • (1999) Lancet. , vol.354 , pp. 716-722
  • 40
    • 0031961328 scopus 로고    scopus 로고
    • Generic substitution - Comparing the clinical efficacy of a generic substitute for fluphenazine decanoate with the original product
    • Verster GC, Joubert G, Stevens M, van der Merwe H. Generic substitution - comparing the clinical efficacy of a generic substitute for fluphenazine decanoate with the original product. S Afr Med J. 1998;88:260-2
    • (1998) S Afr Med J , vol.88 , pp. 260-262
    • Verster, G.C.1    Joubert, G.2    Stevens, M.3    Van Der Merwe, H.4
  • 41
    • 0031886455 scopus 로고    scopus 로고
    • Comparative efficacy and safety of controlled-release morphine suppositories and tablets in cancer pain
    • Babul N, Provencher L, Laberge F, Harsanyi Z, Moulin D. Comparative efficacy and safety of controlled-release morphine suppositories and tablets in cancer pain. J Clin Pharmacol. 1998;38:74-81.
    • (1998) J Clin Pharmacol. , vol.38 , pp. 74-81
    • Babul, N.1    Provencher, L.2    Laberge, F.3    Harsanyi, Z.4    Moulin, D.5


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.