Editorial on hypothesis and objectives in clinical trials: Superiority, equivalence and non-inferiority

Thrombosis Journal

Volumn 7, Issue , 2009, Pages

  Gonzalez, Claudio D ^a   Bolaños, Ricardo ^a   de Sereday, Martha ^b  

^a UNIVERSIDAD DE BUENOS AIRES   (Argentina)

^b Ciudad Autónoma de Buenos Aires   (Argentina)

Author keywords

[No Author keywords available]

Indexed keywords

ALTEPLASE; TENECTEPLASE;

AREA UNDER THE CURVE; BIOEQUIVALENCE; CLINICAL PROTOCOL; CLINICAL STUDY; DRUG EFFICACY; DRUG RESEARCH; EDITORIAL; FIBRINOLYTIC THERAPY; HUMAN; MAXIMUM PLASMA CONCENTRATION; METHODOLOGY; NULL HYPOTHESIS; PHARMACOLOGICAL PARAMETERS; PUBLISHING; TIME TO MAXIMUM PLASMA CONCENTRATION;

EID: 63849238289     PISSN: None     EISSN: 14779560     Source Type: Journal    
DOI: 10.1186/1477-9560-7-3     Document Type: Editorial

References (8)

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2. Lesaffre E Superiority, equivalence and non-inferiority trials Bulletin of the NYU Hospital for Joint Diseases 2008, 66(2):150-154 18537788
3. Chow S-C Liu J-P Classification of Clinical Trials Design and Analysis of Clinical Trials: Concepts and Methodologies John Wiley & Sons, Inc., New Jersey, US Chow, Liu Second 2004, 239-299
4. Wang D Arezina R Bakhai A Bioquivalence Trials Clinical Trials. A practical guide to design, analysis and reporting Remedica, London, UK Wang, Bakhai 2006, 119-129
5. ASSENT 2 Investigators Single-bolus tecneplase compared with front-loaded alteplase in acute myocardial infarction: The ASSSENT-2 double blind randomised trial Lancet 1999, 354:716-722 10.1016/ S0140-6736(99)07403-6 10475182
6. Lesaffre E Bluhmki E Wang-Clow F Berioli S Danays T Fox NL Werf Van de F The general concepts of an equivalence trial, applied to ASSENT-2, a large-scale mortality study comparing two fibrinolytic agents in acute myocardial infarction European Heart Journal 2001, 22(11):898-902 10.1053/euhj.2000.2323 11428813
7. Topol EJ Moliterno DJ Herrmann HC Powers ER Grines CL Cohen DJ Cohen EA Bertrand M Neumann FJ Stone GW DiBattiste PM Demopoulos L TARGET Investigators Comparison of two platelet glycoprotein IIb/IIIa inhibitors, tirofiban and abciximab, for the prevention of ischemic events with percutaneous coronary revascularization New England Journal of Medicine 2001, 344(25):1888-1894 10.1056/NEJM200106213442502 11419425
8. Miller S Neate C Wand D Noninferiority Trials Clinical Trials. A practical guide to design, analysis and reporting Remedica, London, UK Wang, Bakhai 2006, 131-140