EPro : Electronic Solutions for Patient-Reported Data.
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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| Format: | Electronic eBook |
| Language: | English |
| Published: |
Farnham :
Ashgate Pub.,
2010.
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| Online Access: | Full text (Emerson users only) Full text (Emmanuel users only) Full text (NECO users only) Full text (MCPHS users only) Full text (Wentworth users only) |
| Summary: | 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. |
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| Physical Description: | 1 online resource (297 pages) |
| ISBN: | 9781409412427 1409412423 |