방법 비교

	생물학적 동등성 분석 (양측 단측 검정)	동등성 검정 (TOST
분야	계량약리학	통계학
계열	Hypothesis test	Hypothesis test
기원 연도	1987	1987
창시자	Donald J. Schuirmann	Donald J. Schuirmann
유형	Parametric equivalence test	Parametric equivalence test
원전	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.	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.
별칭	TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi	TOST, two one-sided tests, bioequivalence test, Eşdeğerlik Testi (TOST — Two One-Sided Tests)
관련	2	5
요약	Bioequivalence Analysis is a regulatory-grade statistical framework used to determine whether a test drug formulation (generic or reformulated) delivers the active ingredient to the systemic circulation at a rate and extent comparable to a reference product. Introduced by Donald J. Schuirmann in 1987, the method operationalizes equivalence through the Two One-Sided Tests (TOST) procedure, replacing the ambiguous absence-of-difference paradigm with an explicit equivalence margin evaluated on log-transformed pharmacokinetic endpoints such as AUC and C_max.	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.