Recently, there has been much open debate with the regulators around the use of e PRO in clinical drug submissions.US and European agencies have approved new drugs that have included e PRO 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 e Pro addresses these questions, reviews the new FDA guidance, and provides a very contemporary view on this important subject.e Pro is written by Dr Brian Tiplady and published by Gower. ISBNs for e Pro are 9781409458913, 1409458911 and the print ISBNs are 9780566087714, 0566087715.
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