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| Phân tích tương đương sinh học (Hai kiểm định một phía)× | Dược động học quần thể× | |
|---|---|---|
| Lĩnh vực | Trắc lượng dược học | Trắc lượng dược học |
| Họ≠ | Hypothesis test | Regression model |
| Năm ra đời≠ | 1987 | 1977 |
| Người khởi xướng≠ | Donald J. Schuirmann | Sheiner, Rosenberg & Marathe |
| Loại≠ | Parametric equivalence test | Nonlinear mixed-effects regression model |
| Công trình gốc≠ | 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 ↗ | 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. DOI ↗ |
| Tên gọi khác | TOST Procedure, Average Bioequivalence, BE Analysis, Biyoeşdeğerlik Analizi | PopPK, Nonlinear Mixed-Effects Modeling, NONMEM Approach, Popülasyon Farmakokinetiği |
| Liên quan | 2 | 2 |
| Tóm tắt≠ | 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. |
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