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Rethinking Statistical Approaches to Evaluating Drug Safety
PURPOSE: The current methods used to evaluate the efficacy of drug products are inadequate. We propose a non-inferiority approach to prove the safety of drugs. MATERIALS AND METHODS: Traditional hypotheses for the evaluation of the safety of drugs are based on proof of hazard, which have proven to b...
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| Formato: | Texto |
| Lenguaje: | English |
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Yonsei University College of Medicine
2007
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2628183/ https://www.ncbi.nlm.nih.gov/pubmed/18159580 http://dx.doi.org/10.3349/ymj.2007.48.6.895 |