เปรียบเทียบวิธี

	การวิเคราะห์ชีวสมมูล (การทดสอบด้านเดียวสองครั้ง)	การทดสอบสมมูล (TOST	แบบจำลองเชิงปริมาตรเภสัชจลนศาสตร์
สาขาวิชา	เภสัชมิติ	สถิติศาสตร์	เภสัชมิติ
ตระกูล	Hypothesis test	Hypothesis test	Regression model
ปีกำเนิด	1987	1987	1982
ผู้ริเริ่ม	Donald J. Schuirmann	Donald J. Schuirmann	Gibaldi & Perrier
ประเภท	Parametric equivalence test	Parametric equivalence test	Deterministic ODE-based pharmacokinetic model
แหล่งต้นตำรับ	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.	Gibaldi, M., & Perrier, D. (1982). Pharmacokinetics (2nd ed.). Marcel Dekker. ISBN: 978-0-8247-1042-2
ชื่อเรียกอื่น	TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi	TOST, two one-sided tests, bioequivalence test, Eşdeğerlik Testi (TOST — Two One-Sided Tests)	Mammillary Compartment Model, Multi-Compartment PK Model, Compartmental Analysis, Farmakokinetik Kompartman Modeli
ที่เกี่ยวข้อง	2	5	3
สรุป	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.	The pharmacokinetic compartment model represents the body as one or more hypothetical compartments interconnected by first-order rate processes, describing how a drug is absorbed, distributed, and eliminated over time. Systematized by Gibaldi and Perrier in 1982, these models use ordinary differential equations to characterize plasma concentration-time profiles. They are the cornerstone of drug development, dosage regimen design, and regulatory submission pharmacokinetic analyses.