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Analyse de la bioéquivalence (Tests bilatéraux uniques)×Modèle compartimental pharmacocinétique×
DomainePharmacométriePharmacométrie
FamilleHypothesis testRegression model
Année d'origine19871982
Auteur d'origineDonald J. SchuirmannGibaldi & Perrier
TypeParametric equivalence testDeterministic ODE-based pharmacokinetic model
Source fondatriceSchuirmann, 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 ↗Gibaldi, M., & Perrier, D. (1982). Pharmacokinetics (2nd ed.). Marcel Dekker. ISBN: 978-0-8247-1042-2
AliasTOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik AnaliziMammillary Compartment Model, Multi-Compartment PK Model, Compartmental Analysis, Farmakokinetik Kompartman Modeli
Apparentées23
RésuméBioequivalence 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.
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ScholarGateComparer des méthodes: Bioequivalence Analysis · Pharmacokinetic Compartment Model. Consulté le 2026-06-19 sur https://scholargate.app/fr/compare