Providing evidence of efficacy for a new drug

Statistics in Medicine

Volumn 17, Issue 15-16, 1998, Pages 1813-1823

  Ruberg, Stephen ^a   Cairns, Victoria ^a  

^a SANOFI   (France)

Author keywords

[No Author keywords available]

Indexed keywords

CONFERENCE PAPER; DRUG DEVELOPMENT; DRUG EFFECT; DRUG EFFICACY; EUROPE; REGISTRATION; UNITED STATES;

EID: 0032529094     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/(sici)1097-0258(19980815/30)17:15/16<1813::aid-sim983>3.0.co;2-8     Document Type: Conference Paper

References (11)

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3. The Acute Infarction Ramipril Efficacy (AIRE) Study Investigators. 'Effect of ramipril on mortality and morbidity of survivors of acute myocardial infarction with clinical evidence of heart failure', Lancet, 342, No. 8875, 821-828 (1993).
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7. Heidrich, H., Cachovan, M., Creutzig, A., Rieger, H. and Trampisch, H. J. 'Guidelines for therapeutic studies in Fontaine's stages II-IV peripheral arterial occlusive disease', German Society of Angiology, VASA, 24, (2), 114-119 (1995).
8. Heidrich, H., Trampisch, H. J. and Roehmel, J. 'Comments on Guidelines for therapeutic studies in Fontaine's stage II-IV peripheral arterial occlusive disease', German Society of Angiology, VASA, 25 (1), 74-75 (1996).
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10. FDA. 'Guidelines for the clinical evaluation of antidementia drugs', P. Leber, first draft, Nov. 8, Food and Drug Administration, U.S.A., 1990.
11. FDA. 'Guidelines for the clinical evaluation of anti-inflammatory and antirheumatic drugs (adults and children)', September 1977, revised April 1988.