Scientific and regulatory activities initiated by the U.S. food and drug administration to foster approvals of generic dry powder inhalers: Quality perspective
Nashwa El‐Gendy, Craig M. Bertha, Mohammed Abd El-Shafy, Dhaval K. Gaglani, Andrew Babiskin, Elizabeth Bielski, Susan Boc, Sneha Dhapare, Lanyan Fang, Katharine Feibus, Anubhav Kaviratna, Bing V. Li, Markham C. Luke, Tian Ma, Bryan Newman, Michael Spagnola, Ross Walenga, Liang Zhao
Topics & Concepts
Food and drug administrationDry-powder inhalerQuality (philosophy)Quality by DesignProduct (mathematics)BusinessRegulatory scienceRisk analysis (engineering)MedicineNew product developmentInhalerMarketingAsthmaInternal medicinePathologyPhilosophyEpistemologyGeometryMathematicsInhalation and Respiratory Drug DeliveryDrug Solubulity and Delivery SystemsIntravenous Infusion Technology and Safety