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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Dettagli Bibliografici
Pubblicato in:Oncologist
Autori principali: Hansen, Aaron R., Cook, Natalie, Ricci, M. Stacey, Razak, Albiruni, Le Tourneau, Christophe, McKeever, Kathleen, Roskos, Lorin, Dixit, Rakesh, Siu, Lillian L., Hinrichs, Mary Jane
Natura: Artigo
Lingua:Inglês
Pubblicazione: AlphaMed Press 2015
Soggetti:
New Drug Development and Clinical Pharmacology
Accesso online: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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