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How large must a dose‐optimization trial be?
Recently promulgated Draft Guidance from the US Food and Drug Administration Oncology Center of Excellence (OCE) recommends randomized, parallel dose–response trials for “dose optimization,” but with vaguely stated aims that engage none of the statistical principles which typically attend randomizat...
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
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John Wiley and Sons Inc.
2023
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| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10681487/ https://www.ncbi.nlm.nih.gov/pubmed/37667540 http://dx.doi.org/10.1002/psp4.13041 |