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Reviewing the role of healthy volunteer studies in drug development

BACKGROUND: With the exception of genotoxic oncology drugs, first-in-human, Phase 1 clinical studies of investigational drugs have traditionally been conducted in healthy volunteers (HVs). The primary goal of these studies is to investigate the pharmacokinetics and pharmacodynamics of a novel drug c...

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Detalles Bibliográficos
Autores principales:	Karakunnel, Joyson J., Bui, Nam, Palaniappan, Latha, Schmidt, Keith T., Mahaffey, Kenneth W., Morrison, Briggs, Figg, William D., Kummar, Shivaani
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BioMed Central 2018
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6278009/ https://www.ncbi.nlm.nih.gov/pubmed/30509294 http://dx.doi.org/10.1186/s12967-018-1710-5

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