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Saggio di Equivalenza / Non-Inferiorità×Disegno Sperimentale Crossover×
CampoDisegno sperimentaleDisegno sperimentale
FamigliaHypothesis testHypothesis test
Anno di origine19871960
IdeatoreSchuirmann, D.J. / EMA regulatory frameworkEarly formalized in clinical research literature; widely used since mid-20th century
TipoParametric equivalence / non-inferiority testWithin-subject repeated-measures design
Fonte seminaleSchuirmann, 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 ↗Senn, S. (2002). Cross-over Trials in Clinical Research (2nd ed.). Wiley. ISBN: 978-0471496533
Aliasnon-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)within-subject crossover, cross-over design, AB/BA design, Çapraz Desen (Crossover Design)
Correlati66
SintesiAn 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.A crossover design is an experimental design in which each participant receives all treatments under investigation, but in a different sequence and across separate time periods. Each subject thus acts as their own control, which substantially reduces between-subject variability and allows efficient treatment comparisons with smaller sample sizes. The approach has been central to clinical pharmacology and comparative research since the mid-20th century, with foundational methodology codified by Senn (2002) and Jones & Kenward (2014).
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ScholarGateConfronta i metodi: Equivalence / Non-Inferiority Trial · Crossover Design. Consultato il 2026-06-18 da https://scholargate.app/it/compare