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Improper Selection of a Pre-specified Primary Dose–Response Analysis Delays Regulatory Drug Approval
Dose–response analysis is one of the accepted efficacy endpoints to establish effectiveness. The purpose of this research was to inform selection of an appropriate pre-specified primary dose–response analysis to demonstrate drug efficacy in a registration trial. The power and the type I error rate o...
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| Hauptverfasser: | , , , |
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| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
Springer US
2013
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC3675735/ https://ncbi.nlm.nih.gov/pubmed/23307587 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/s12248-012-9438-2 |
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