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.
Rekodi ya chanzo
Nukuu zimehamishwa kwa uhalisi kutoka kwa rekodi ya chanzo cha mbinu. Hakuna uthibitisho wa kiwango cha dai unaodokezwa kutoka kwao.
- 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
Madai yaliyotunzwa
Madai yamehifadhiwa katika daftari la ushahidi, kila moja ikiwa na tathmini yake.
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.