مقایسهٔ روشها
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| آزمایش برابری / عدمِفوقانی× | آزمون همارزی (TOST× | |
|---|---|---|
| حوزه≠ | طراحی آزمایش | آمار |
| خانواده | Hypothesis test | Hypothesis test |
| سال پیدایش | 1987 | 1987 |
| پدیدآور≠ | Schuirmann, D.J. / EMA regulatory framework | Donald J. Schuirmann |
| نوع≠ | Parametric equivalence / non-inferiority test | Parametric equivalence test |
| منبع بنیادین≠ | Schuirmann, D.J. (1987). A Comparison of the Two One-Sided Tests Procedure and the Power Approach. Journal of Pharmacokinetics and Biopharmaceutics, 15(6), 657–680. link ↗ | 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 ↗ |
| نامهای دیگر | non-inferiority trial, bioequivalence study, active-control trial, Denklik ve Üstünlük Olmayan Çalışma (Equivalence / Non-Inferiority) | TOST, two one-sided tests, bioequivalence test, Eşdeğerlik Testi (TOST — Two One-Sided Tests) |
| مرتبط≠ | 6 | 5 |
| خلاصه≠ | An equivalence or non-inferiority trial is a clinical study design that tests whether a new intervention is clinically equivalent to, or no worse than, an established standard by a pre-specified margin. Codified in Schuirmann's 1987 Two One-Sided Tests (TOST) framework and embedded in EMA and FDA regulatory guidance, this design is the regulatory standard for generic drug approval and medical device testing. | 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. |
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