So sánh phương pháp

	Phân tích tương đương sinh học (Hai kiểm định một phía)	Mô hình dược động học theo khoang
Lĩnh vực	Trắc lượng dược học	Trắc lượng dược học
Họ	Hypothesis test	Regression model
Năm ra đời	1987	1982
Người khởi xướng	Donald J. Schuirmann	Gibaldi & Perrier
Loại	Parametric equivalence test	Deterministic ODE-based pharmacokinetic model
Công trình gốc	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
Tên gọi khác	TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi	Mammillary Compartment Model, Multi-Compartment PK Model, Compartmental Analysis, Farmakokinetik Kompartman Modeli
Liên quan	2	3
Tóm tắt	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.