Phase 0 Clinical Trials: Conceptions and Misconceptions

Phase 0 clinical trials, developed in response to the United States Food and Drug Administration (FDA)’s recent exploratory Investigational New Drug (IND) guidance, are intended to expedite the clinical evaluation of new molecular entities. The exploratory IND supports the performance of first-in-hu...

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Detalhes bibliográficos
Publicado no:Cancer J
Main Authors: Kummar, Shivaani, Rubinstein, Larry, Kinders, Robert, Parchment, Ralph E., Gutierrez, Martin E., Murgo, Anthony J., Ji, Jay, Mroczkowski, Barbara, Pickeral, Oxana K., Simpson, Mel, Hollingshead, Melinda, Yang, Sherry X., Helman, Lee, Wiltrout, Robert, Collins, Jerry, Tomaszewski, Joseph E., Doroshow, James H.
Formato: Artigo
Idioma:Inglês
Publicado em: 2008
Assuntos:
Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC7185299/
https://ncbi.nlm.nih.gov/pubmed/18536551
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1097/PPO.0b013e318172d6f3
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