방법 비교

	생물학적 동등성 분석 (양측 단측 검정)	약동학 구획 모델
분야	계량약리학	계량약리학
계열	Hypothesis test	Regression model
기원 연도	1987	1982
창시자	Donald J. Schuirmann	Gibaldi & Perrier
유형	Parametric equivalence test	Deterministic ODE-based pharmacokinetic model
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.	Gibaldi, M., & Perrier, D. (1982). Pharmacokinetics (2nd ed.). Marcel Dekker. ISBN: 978-0-8247-1042-2
별칭	TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi	Mammillary Compartment Model, Multi-Compartment PK Model, Compartmental Analysis, Farmakokinetik Kompartman Modeli
관련	2	3
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 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.