Role of patient-reported outcomes and other efficacy endpoints in the drug approval process in Europe (2008-2012)

• मुख्य लेखकों: Dipika Bansal (लेखक), Anil Bhagat (लेखक), Fabrizio Schifano (लेखक), Kapil Gudala (लेखक)
• स्वरूप: पुस्तक
• प्रकाशित: Springer, 2019-04-01T00:00:00Z.
• विषय: article
• ऑनलाइन पहुंच: Connect to this object online.

The present study aimed at systematically reviewing the role and extent of patient-reported outcomes (PROs) usage within the package of scientific evidence considered for marketing authorization (MA). All regulatory information published by the European Medicines Agency (EMA) for products authorized...