方法对比

	等效性/非劣效性试验	t检验的功效分析
领域	实验设计	统计学
方法族	Hypothesis test	Hypothesis test
起源年份	1987	1969
提出者	Schuirmann, D.J. / EMA regulatory framework	Jacob Cohen
类型	Parametric equivalence / non-inferiority test	Sample size determination
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.	Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences (2nd ed.). Lawrence Erlbaum Associates. ISBN: 978-0805802832
别名	non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)	t-test power analysis, sample size calculation for t-test, Güç Analizi — t-Testi
相关	6	5
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.	Power analysis for the t-test is a sample size planning procedure that determines how many participants are required to detect a mean difference of a given magnitude with acceptable probability. Formalised by Jacob Cohen in his 1969 and 1988 editions of Statistical Power Analysis for the Behavioral Sciences, it links four quantities — effect size (Cohen's d), significance level (α), statistical power (1 − β), and sample size — so that fixing any three allows calculation of the fourth.