Quality risk assessment and DoE-based analytical quality by design approach to stability-indicating assay method for acidic degradation kinetic study of apremilast
Pintu Prajapati, Hitika B. Patel, Shailesh Shah
Topics & Concepts
Quality by DesignDesign of experimentsQuality (philosophy)Risk assessmentForced degradationCritical quality attributesRisk analysis (engineering)Process engineeringReliability engineeringComputer scienceEngineeringChromatographyOperations managementChemistryStatisticsMathematicsBusinessHigh-performance liquid chromatographyDownstream (manufacturing)EpistemologyAmmonium formateComputer securityPhilosophyThermal and Kinetic AnalysisAnalytical Methods in PharmaceuticalsPesticide Residue Analysis and Safety