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Фармакокинетичен компартментен модел×Анализ на биоеквивалентност (Два едностранни теста)×Модел Емакс: Фармакодинамичен анализ на зависимостта доза-отговор×
ОбластФармакометрияФармакометрияФармакометрия
СемействоRegression modelHypothesis testRegression model
Година на възникване198219871981
СъздателGibaldi & PerrierDonald J. SchuirmannHolford & Sheiner
ТипDeterministic ODE-based pharmacokinetic modelParametric equivalence testNonlinear dose-response regression model
Основополагащ източникGibaldi, 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 ↗Holford, N. H. G., & Sheiner, L. B. (1981). Understanding the dose-effect relationship: clinical application of pharmacokinetic-pharmacodynamic models. Clinical Pharmacokinetics, 6(6), 429–453. DOI ↗
Други названияMammillary Compartment Model, Multi-Compartment PK Model, Compartmental Analysis, Farmakokinetik Kompartman ModeliTOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik AnaliziMaximum Effect Model, Hyperbolic Emax Model, Sigmoidal Emax Model, Emax Farmakodynamik Modeli
Свързани322
РезюмеThe 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.The Emax model is a nonlinear pharmacodynamic model that describes the relationship between drug concentration and biological effect. Introduced by Holford and Sheiner in 1981, it characterizes dose-response curves using three fundamental parameters: the maximum achievable effect (Emax), the concentration producing half-maximal effect (EC50), and an optional baseline effect (E0). It remains the standard framework in clinical pharmacology and drug development for quantifying pharmacodynamic dose-response relationships.
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ScholarGateСравнение на методи: Pharmacokinetic Compartment Model · Bioequivalence Analysis · Emax Model. Извлечено на 2026-06-20 от https://scholargate.app/bg/compare