手法を比較

	等価性／非劣性試験	等価性検定（TOST
分野	実験計画法	統計学
系統	Hypothesis test	Hypothesis test
提唱年	1987	1987
提唱者	Schuirmann, D.J. / EMA regulatory framework	Donald J. Schuirmann
種類	Parametric equivalence / non-inferiority test	Parametric equivalence test
原典	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.	Schuirmann, D.J. (1987). A Comparison of the Two One-Sided Tests Procedure and the Power Approach for Assessing the Equivalence of Average Bioavailability. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657–680.
別名	non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority)	TOST, two one-sided tests, bioequivalence test, Eşdeğerlik Testi (TOST — Two One-Sided Tests)
関連	6	5
概要	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.	The equivalence test using the Two One-Sided Tests (TOST) procedure is a parametric hypothesis test designed to demonstrate that the difference between two group means falls within a pre-specified equivalence region ±Δ. Introduced by Schuirmann (1987) in the context of pharmaceutical bioequivalence, TOST reverses the logic of classical null-hypothesis testing: instead of trying to detect a difference, it provides positive evidence of similarity.