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Hypothesis test

Kesiwepesi / Kesiwepesi ya Kutokuwa duni (Equivalence / Non-Inferiority Trial)

Kesiwepesi au kesiwepesi ya kutokuwa duni ni muundo wa utafiti wa kimatibabu unaojaribu kama matibabu mapya yanafanana kimatibabu na, au si duni kuliko, kiwango kilichoanzishwa kwa kiwango kilichofafanuliwa awali. Ulioandikwa katika mfumo wa Schuirmann wa 1987 wa Vipimo Vya Kimoja Vya Kimoja (TOST) na kuingizwa katika miongozo ya udhibiti ya EMA na FDA, muundo huu ndio kiwango cha udhibiti kwa ajili ya kuidhinisha dawa za jumla na kupima vifaa tiba.

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Vyanzo

  1. 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
  2. EMA (2010). Guideline on the Investigation of Bioequivalence. CPMP/EWP/QWP/1401/98 Rev. 1. European Medicines Agency. link

Jinsi ya kunukuu ukurasa huu

ScholarGate. (2026, June 1). Equivalence and Non-Inferiority Clinical Trial Design. ScholarGate. https://scholargate.app/sw/experimental-design/equivalence-trial

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Imerejelewa na

ScholarGateEquivalence / Non-Inferiority Trial (Equivalence and Non-Inferiority Clinical Trial Design). Imepatikana 2026-06-15 kutoka https://scholargate.app/sw/experimental-design/equivalence-trial · Seti ya data: https://doi.org/10.5281/zenodo.20539026