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Bioækvivalensanalyse (To ensidede tests)ׯkvivalenstest (TOST×Farmakokinetisk kompartmentmodel×
FagområdeFarmakometriStatistikFarmakometri
FamilieHypothesis testHypothesis testRegression model
Oprindelsesår198719871982
OphavspersonDonald J. SchuirmannDonald J. SchuirmannGibaldi & Perrier
TypeParametric equivalence testParametric equivalence testDeterministic ODE-based pharmacokinetic model
Oprindelig kildeSchuirmann, 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 ↗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 ↗Gibaldi, M., & Perrier, D. (1982). Pharmacokinetics (2nd ed.). Marcel Dekker. ISBN: 978-0-8247-1042-2
AliasserTOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik AnaliziTOST, two one-sided tests, bioequivalence test, Eşdeğerlik Testi (TOST — Two One-Sided Tests)Mammillary Compartment Model, Multi-Compartment PK Model, Compartmental Analysis, Farmakokinetik Kompartman Modeli
Relaterede253
ResuméBioequivalence 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 equivalence test using the Two One-Sided Tests (TOST) procedure is a parametric hypothesis test designed to demonstrate that the difference between two group means falls within a pre-specified equivalence region ±Δ. Introduced by Schuirmann (1987) in the context of pharmaceutical bioequivalence, TOST reverses the logic of classical null-hypothesis testing: instead of trying to detect a difference, it provides positive evidence of similarity.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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ScholarGateSammenlign metoder: Bioequivalence Analysis · Equivalence Test (TOST) · Pharmacokinetic Compartment Model. Hentet 2026-06-20 fra https://scholargate.app/da/compare