University of Hertfordshire

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Original languageEnglish
Pages (from-to)250-256
Number of pages7
JournalTherapeutic Innovation & Regulatory Science
Volume20
Issue3
Early online date15 Sep 2016
DOIs
Publication statusPublished - 10 Apr 2017

Abstract

Although the quality of decision making (QDM) in the development and regulatory review of medicines influences the delivery of new products, there appears to be no suitable instrument to assess QDM in this area. The aim of this study was to assess differences in QDM using a validated instrument, the Quality of Decision-Making Orientation Scheme (QoDoS), to identify best practices and biases affecting individuals and their organization, as well as to assess differences in decision-making behaviors between pharmaceutical companies and regulatory agencies. QoDoS also enables the measurement against 10 quality decision-making practices (QDMPs) that underpin a quality process

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