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Modelo Compartimental Farmacocinético×Análisis de Bioequivalencia (Dos Pruebas Unilaterales)×
CampoFarmacometríaFarmacometría
FamiliaRegression modelHypothesis test
Año de origen19821987
Autor originalGibaldi & PerrierDonald J. Schuirmann
TipoDeterministic ODE-based pharmacokinetic modelParametric equivalence test
Fuente seminalGibaldi, M., & Perrier, D. (1982). Pharmacokinetics (2nd ed.). Marcel Dekker. ISBN: 978-0-8247-1042-2Schuirmann, 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 ↗
AliasMammillary Compartment Model, Multi-Compartment PK Model, Compartmental Analysis, Farmakokinetik Kompartman ModeliTOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi
Relacionados32
ResumenThe 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.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.
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ScholarGateComparar métodos: Pharmacokinetic Compartment Model · Bioequivalence Analysis. Recuperado el 2026-06-19 de https://scholargate.app/es/compare