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Determination of the starting dose in the first-in-human clinical trials with monoclonal antibodies: a systematic review of papers published between 1990 and 2013

A systematic review was performed to evaluate how the maximum recommended starting dose (MRSD) was determined in first-in-human (FIH) studies with monoclonal antibodies (mAbs). Factors associated with the choice of each MRSD determination method were also identified. PubMed was searched for FIH stud...

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Detalles Bibliográficos
Autores principales: Suh, Hoon Young, Peck, Carl C, Yu, Kyung-Sang, Lee, Howard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Dove Medical Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5153257/
https://www.ncbi.nlm.nih.gov/pubmed/27994442
http://dx.doi.org/10.2147/DDDT.S121520