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Is the “3+3” dose escalation phase 1 clinical trial design suitable for therapeutic cancer vaccine development? A recommendation for alternative design
PURPOSE: Phase 1 clinical trials are generally conducted to identify the maximum tolerated dose (MTD) or the biologically active dose (BAD) using a traditional dose escalation design. This design may not be applied to cancer vaccines, given their unique mechanism of action. The FDA recently publishe...
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| Main Authors: | , , , |
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| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
2014
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4167476/ https://ncbi.nlm.nih.gov/pubmed/25037736 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1158/1078-0432.CCR-13-2671 |
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