EPro : Electronic Solutions for Patient-Reported Data.

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Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Byrom, Bill
Otros Autores: Tiplady, Brian
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Farnham : Ashgate Pub., 2010.
Temas:
Clinical trials > Data processing.
Outcome assessment (Medical care) > Data processing.
Études cliniques > Informatique.
Évaluation des résultats (Soins médicaux) > Informatique.
Clinical trials > Data processing
Acceso en línea:Texto completo
Descripción
Sumario:Recently, there has been much open debate with the regulators around the use of ePRO in clinical drug submissions. US and European agencies have approved new drugs that have included ePRO data in the submission dossier, but there are many questions around the adoption of the technology that concern the community. Bill Byrom and Brian Tiplady's ePro addresses these questions, reviews the new FDA guidance, and provides a very contemporary view on this important subject.
Descripción Física:1 online resource (297 pages)
ISBN:9781409412427
1409412423

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