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Choice of Starting Dose for Biopharmaceuticals in First-in-Human Phase I Cancer Clinical Trials
BACKGROUND. First-in-human (FIH) trials of low-molecular-weight anticancer agents conventionally derive a safe start dose (SD) from one-tenth the severely toxic dose in 10% of rodents or one-sixth the highest nonseverely toxic dose (HNSTD) in nonrodent species. No consensus has been reached on wheth...
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| Publicado no: | Oncologist |
|---|---|
| Main Authors: | , , , , , , , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
AlphaMed Press
2015
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC4571794/ https://ncbi.nlm.nih.gov/pubmed/25964306 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1634/theoncologist.2015-0008 |
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