方法对比

	等效性/非劣效性试验	交叉设计
领域	实验设计	实验设计
方法族	Hypothesis test	Hypothesis test
起源年份	1987	1960
提出者	Schuirmann, D.J. / EMA regulatory framework	Early formalized in clinical research literature; widely used since mid-20th century
类型	Parametric equivalence / non-inferiority test	Within-subject repeated-measures design
开创性文献	Schuirmann, 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.	Senn, S. (2002). Cross-over Trials in Clinical Research (2nd ed.). Wiley. ISBN: 978-0471496533
别名	non-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)
相关	6	6
摘要	An 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).