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Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union

BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicine...

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Detalles Bibliográficos
Autores principales: Clark, Marci J, Harris, Nimanee, Griebsch, Ingolf, Kaschinski, Dagmar, Copley-Merriman, Catherine
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4104468/
https://www.ncbi.nlm.nih.gov/pubmed/24989428
http://dx.doi.org/10.1186/s12955-014-0104-5