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जैव-समतुल्यता विश्लेषण (दो एक-तरफ़ा परीक्षण)×समतुल्यता परीक्षण (TOST×
क्षेत्रऔषधमितिसांख्यिकी
परिवारHypothesis testHypothesis test
उद्भव वर्ष19871987
प्रवर्तकDonald J. SchuirmannDonald J. Schuirmann
प्रकारParametric equivalence testParametric equivalence test
मौलिक स्रोतSchuirmann, 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. DOI ↗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. DOI ↗
उपनामTOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik AnaliziTOST, two one-sided tests, bioequivalence test, Eşdeğerlik Testi (TOST — Two One-Sided Tests)
संबंधित25
सारांशBioequivalence 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.
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ScholarGateविधियों की तुलना करें: Bioequivalence Analysis · Equivalence Test (TOST). 2026-06-19 को यहाँ से प्राप्त https://scholargate.app/hi/compare