Dose Finding in the Clinical Development of 60 US Food and Drug Administration–Approved Drugs Compared With Learning vs. Confirming Recommendations

This review characterizes clinical development that supported the label dose in 60 drug indications recently approved by the US Food and Drug Administration. With Lewis B. Sheiner's Learning vs. Confirming clinical drug development paradigm as a reference point, the clinical development paths,...

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Detalles Bibliográficos
Autores principales: Lyauk, Yassine Kamal, Jonker, Daniël Martijn, Lund, Trine Meldgaard
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2019
Materias:
Research
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742935/
https://www.ncbi.nlm.nih.gov/pubmed/31254374
http://dx.doi.org/10.1111/cts.12641

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6742935/
https://www.ncbi.nlm.nih.gov/pubmed/31254374
http://dx.doi.org/10.1111/cts.12641

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