Orally Inhaled Drug Product PSGs: General Considerations Using the Alternative Bioequivalence (BE) Approach In Lieu of Comparative Clinical Endpoint (CCEP) BE Study for Suspension-Based Metered Dose Inhalers

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Author/sHan, Liangfeng
Date:09/24/2024
Meeting Name:Small Business and Industry Assistance (SBIA) Workshop: Advancing Generic Drug Development: Translating Science to Approval 2024
State:MD
City:Bethesda