השוואת שיטות

	ניתוח שקילות ביולוגית (שני מבחנים חד-צדדיים)	מודל Emax: ניתוח תגובת מינון-פרמקודינמיקה	פרמקוקינטיקה של אוכלוסיות
תחום	פרמקומטריקה	פרמקומטריקה	פרמקומטריקה
משפחה	Hypothesis test	Regression model	Regression model
שנת המקור	1987	1981	1977
הוגה השיטה	Donald J. Schuirmann	Holford & Sheiner	Sheiner, Rosenberg & Marathe
סוג	Parametric equivalence test	Nonlinear dose-response regression model	Nonlinear mixed-effects regression model
מקור מכונן	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.	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.	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.
כינויים	TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi	Maximum Effect Model, Hyperbolic Emax Model, Sigmoidal Emax Model, Emax Farmakodynamik Modeli	PopPK, Nonlinear Mixed-Effects Modeling, NONMEM Approach, Popülasyon Farmakokinetiği
קשורות	2	2	2
תקציר	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.	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.