The first part of an in-depth article on Quality by Design (QbD), published in European Pharmaceutical Review in December 2016, focused on designing quality in to a pharmaceutical drug product by considering dosage form design, and understanding the importance of active pharmaceutical ingredients’ (APIs’) and excipients’ properties.
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Quality by Design (QbD) precepts provide opportunities for enhancing efficiencies and reducing costs, especially for generic products. Over 80% of prescriptions dispensed in the United States in 2012 utilised generic dosage forms and it is unlikely that this proportion will increase to any extent because fewer innovative drugs are set…