Quality by design (QbD) approach in marketing authorization procedures of Non-Biological Complex Drugs: A critical evaluation
Daniela M. Zagalo, João Sousa, Sérgio Simões
Topics & Concepts
Quality by DesignFlexibility (engineering)Risk analysis (engineering)Quality (philosophy)Computer sciencePharmaceutical industryProcess (computing)Critical quality attributesProcess managementMarketing authorizationAuthorizationBiochemical engineeringManagement scienceNew product developmentBusinessEngineeringMarketingMedicinePharmacologyComputer securityBioinformaticsStatisticsMathematicsEpistemologyPhilosophyBiologyOperating systemBiosimilars and Bioanalytical MethodsPharmaceutical Economics and PolicyComputational Drug Discovery Methods