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	Analýza bioekvivalencie (dva jednostranné testy)	Populacionálna farmakokinetika
Odbor	Farmakometria	Farmakometria
Rodina	Hypothesis test	Regression model
Rok vzniku	1987	1977
Tvorca	Donald J. Schuirmann	Sheiner, Rosenberg & Marathe
Typ	Parametric equivalence test	Nonlinear mixed-effects regression model
Pôvodný zdroj	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.	Sheiner, L. B., Rosenberg, B., & Marathe, V. V. (1977). Estimation of population characteristics of pharmacokinetic parameters from routine clinical data. Journal of Pharmacokinetics and Biopharmaceutics, 5(5), 445–479.
Ďalšie názvy	TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi	PopPK, Nonlinear Mixed-Effects Modeling, NONMEM Approach, Popülasyon Farmakokinetiği
Príbuzné	2	2
Zhrnutie	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.	Population Pharmacokinetics (PopPK) is a nonlinear mixed-effects modeling framework that characterizes how drugs are absorbed, distributed, metabolized, and eliminated across a patient population, estimating both typical population parameters and the magnitude of between-subject variability. Introduced by Sheiner, Rosenberg, and Marathe in 1977, it enables parameter estimation from sparse, routinely collected clinical data—making it indispensable in drug development, regulatory submissions, and individualized dosing.