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FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply

Philip J Almeter, James T Isaacs, Aaron N Hunter, Bradley S Henderson, Thomas L Platt, Billie J. Mitchell, David Do, Alyssa B. Brainard, J. Elliott Brown, Rachael M. Stone, Bao-Han Nguyen, Matthew F Warren, Smaran A Bhaktawara, Megan N Bossle, Lindsey M Long, Stephanie P Zapata, Cinnamon R. Larkin, Thomas A Lyman, Seth A. Larkin, Jonathan A. Labuhn, Jeffrey W. Reynolds, Erin E. Schuler, Ryan W. Naseman, Gary L. Johnson, Robert A. Lodder

2022Journal of Pharmaceutical Innovation18 citationsDOIOpen Access PDF

Topics & Concepts

Quality (philosophy)DrugRisk analysis (engineering)Quality by DesignPharmaceutical drugPharmaceutical manufacturingSupply chainGood manufacturing practiceDrug detectionFood and drug administrationBusinessOperations managementMedicineEngineeringMarketingPharmacologyNew product developmentChromatographyEpistemologyChemistryPhilosophyPharmaceutical Quality and CounterfeitingPharmaceutical Economics and PolicyBiosimilars and Bioanalytical Methods
FDA Approaches in Monitoring Drug Quality, Forces Impacting the Drug Quality, and Recent Alternative Strategies to Assess Quality in the US Drug Supply | Litcius