Dennis Lock
Gower
Paperback
544
2007
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.
Gower
Paperback
544
2007
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.