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समतुल्यता / गैर-हीनता परीक्षण×क्रमिक / समूह क्रमिक परीक्षण डिज़ाइन×
क्षेत्रप्रयोगात्मक अभिकल्पप्रयोगात्मक अभिकल्प
परिवारHypothesis testHypothesis test
उद्भव वर्ष19871979
प्रवर्तकSchuirmann, D.J. / EMA regulatory frameworkO'Brien & Fleming; Pocock; Lan & DeMets
प्रकारParametric equivalence / non-inferiority testAdaptive stopping trial design
मौलिक स्रोतSchuirmann, D.J. (1987). A Comparison of the Two One-Sided Tests Procedure and the Power Approach. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657–680. link ↗O'Brien, P.C. & Fleming, T.R. (1979). A Multiple Testing Procedure for Clinical Trials. Biometrics, 35(3), 549–556. DOI ↗
उपनामnon-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)group sequential design, adaptive stopping design, Ardışık Deneme Tasarımı (Sequential / Group Sequential)
संबंधित63
सारांशAn equivalence or non-inferiority trial is a clinical study design that tests whether a new intervention is clinically equivalent to, or no worse than, an established standard by a pre-specified margin. Codified in Schuirmann's 1987 Two One-Sided Tests (TOST) framework and embedded in EMA and FDA regulatory guidance, this design is the regulatory standard for generic drug approval and medical device testing.Sequential and group sequential trial designs allow a study to be stopped early — or continued — based on interim analyses conducted as data accumulate. The core framework was formalised by O'Brien and Fleming in 1979 and extended by Lan and DeMets's alpha-spending approach, and it controls the overall Type I error rate across all planned looks by pre-specifying both efficacy and futility boundaries before enrolment begins.
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ScholarGateविधियों की तुलना करें: Equivalence / Non-Inferiority Trial · Sequential Design. 2026-06-19 को यहाँ से प्राप्त https://scholargate.app/hi/compare