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Discordant MIC Analysis: A New Path to Licensure for Anti-infective Drugs
BACKGROUND: Evaluation of anti-infective drugs for licensure often relies on a noninferiority (NI) design where new drug B is noninferior to comparator drug A if the difference in success rates is reliably not worse than some fixed margin. The margin must be based on historical studies that estimate...
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| Autori principali: | , , |
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| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
2013
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3845416/ https://ncbi.nlm.nih.gov/pubmed/24287133 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/1740774513507503 |
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