메뉴 건너뛰기




Volumn 20, Issue 1, 1999, Pages 16-39

Carvedilol and the Food and Drug Administration (FDA) approval process: The FDA paradigm and reflections on hypothesis testing

Author keywords

Advisory committee; Alpha blocker; Beta blocker; Carvedilol; Congestive heart failure; FDA; FDA paradigm; strength of evidence; Type I error

Indexed keywords

CARVEDILOL; NEW DRUG;

EID: 0032971979     PISSN: 01972456     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0197-2456(98)00054-3     Document Type: Article
Times cited : (66)

References (9)
  • 1
    • 0033011501 scopus 로고    scopus 로고
    • Carvedilol and the Food and Drug Administration approval process: an introduction
    • L.D. Fisher L.A. Moyé Carvedilol and the Food and Drug Administration approval process an introduction Controlled Clin Trials 20 1999 1 15
    • (1999) Controlled Clin Trials , vol.20 , pp. 1-15
    • Fisher, L.D.1    Moyé, L.A.2
  • 2
    • 0024321898 scopus 로고
    • Preliminary report: effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
    • Cardiac Arrhythmia Trial (CAST) Investigators Preliminary report effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction N Engl J Med 321 1989 406 412
    • (1989) N Engl J Med , vol.321 , pp. 406-412
    • Cardiac Arrhythmia Trial (CAST) Investigators1
  • 3
    • 85119798671 scopus 로고    scopus 로고
    • Packer M, Carver JR, Rodeheffer RJ, et al. for the PROMISE Study Research Group. Effect of oral milrinone on mortality in severe chronic heart failure. N Engl J Med 1991;325:1468–1475.
  • 4
    • 85119800387 scopus 로고    scopus 로고
    • Packer M, Rouleau J, Swedberg K, et al. and the Profile Investigators & Coordinators. Effect of flosqsequinan on survival in chronic heart failure: preliminary results of the PROFILE study [abstract 1612]. Circulation 1993;88(Suppl. I):I–301.
  • 5
    • 85119803717 scopus 로고    scopus 로고
    • R. Royall Statistical Evidence A Likelihood Paradigm 1997 Chapman and Hall London
    • (1997)
    • Royall, R.1
  • 6
    • 0002516459 scopus 로고
    • Sequential trials, sequential analysis and the likelihood principle
    • J. Cornfield Sequential trials, sequential analysis and the likelihood principle Am Stat 20 1966 18 22
    • (1966) Am Stat , vol.20 , pp. 18-22
    • Cornfield, J.1
  • 7
    • 0029937949 scopus 로고    scopus 로고
    • The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group
    • M. Packer M.R. Bristow J.M. Cohn The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. U.S. Carvedilol Heart Failure Study Group N Engl J Med 334 1996 1349 1355
    • (1996) N Engl J Med , vol.334 , pp. 1349-1355
    • Packer, M.1    Bristow, M.R.2    Cohn, J.M.3
  • 8
    • 85119808636 scopus 로고
    • R.W. Emerson Familiar Quotations by John Bartlett 1955 Little, Brown & Company Boston
    • (1955)
    • Emerson, R.W.1
  • 9
    • 0032972732 scopus 로고    scopus 로고
    • Endpoint Interpretation in clinical trials: the case for discipline
    • L. Moyé Endpoint Interpretation in clinical trials the case for discipline Controlled Clin Trials 20 1999 40 49
    • (1999) Controlled Clin Trials , vol.20 , pp. 40-49
    • Moyé, L.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.