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Equivalence / Non-Inferiority Trial/Ushahidi
Rekodi ya ushahidi wa mbinu

Equivalence / Non-Inferiority Trial

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.

Sources recorded, not reviewed

Rekodi ya chanzo

Nukuu zimehamishwa kwa uhalisi kutoka kwa rekodi ya chanzo cha mbinu. Hakuna uthibitisho wa kiwango cha dai unaodokezwa kutoka kwao.

Equivalence and Non-Inferiority Clinical Trial Design
Rekodi ya mbinu ya kiajenda · hypothesis-test / experimental-design
  • 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. · URL
  • EMA (2010). Guideline on the Investigation of Bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1. European Medicines Agency. · URL
Fungua mbinu kamili

Madai yaliyotunzwa

Madai yamehifadhiwa katika daftari la ushahidi, kila moja ikiwa na tathmini yake.

Hakuna madai yaliyotunzwa bado

Mwonekano huu haubuni tathmini ya dai wakati daftari haina yoyote.

Mbinu zinazohusiana

Zilizotengenezwa kutoka kwa grafu ya mbinu na kuonyeshwa kama uhusiano uliopendekezwa na mashine — hakuna dai la ushahidi linalodokezwa.

Same method familyAdaptive Clinical Trial Designmachine-suggested · Relational suggestion, not evidence.Same method familyCrossover Designmachine-suggested · Relational suggestion, not evidence.Same method familyEquivalence Test (TOST)machine-suggested · Relational suggestion, not evidence.Same method familyPower Analysis for t-testmachine-suggested · Relational suggestion, not evidence.Same method familyRandomized Controlled Trialmachine-suggested · Relational suggestion, not evidence.Same method familySequential Analysismachine-suggested · Relational suggestion, not evidence.

Hali ya ushahidi

Sources recorded, not reviewed

Bibliographic sources are present. Claim-level evidence review has not been performed.

Vyanzo

2 nukuu zilizorekodiwa, ziliyonakiliwa kutoka kwa rekodi ya chanzo cha mbinu.

Vitendo

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