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| Analisi di Bioequivalenza (Two One-Sided Tests)× | Modello Emax: Analisi Farmacodinamica Dose-Risposta× | |
|---|---|---|
| Campo | Farmacometria | Farmacometria |
| Famiglia≠ | Hypothesis test | Regression model |
| Anno di origine≠ | 1987 | 1981 |
| Ideatore≠ | Donald J. Schuirmann | Holford & Sheiner |
| Tipo≠ | Parametric equivalence test | Nonlinear dose-response regression model |
| Fonte seminale≠ | 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. 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 ↗ |
| Alias | TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi | Maximum Effect Model, Hyperbolic Emax Model, Sigmoidal Emax Model, Emax Farmakodynamik Modeli |
| Correlati | 2 | 2 |
| Sintesi≠ | 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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