Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presentations
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 Inhaler
Liangfeng Han, MD, PhD
Clinical Analyst
Division of Therapeutic Performance 1 (DTP-1)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Orally Inhaled Drug Product PSGs: Considerations for Using Modeling and Simulation with Alternative BE Approaches
Ross Walenga, PhD
Senior Chemical Engineer
Division of Quantitative Methods and Modeling (DQMM)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
OPQR Testing & Research to Support Guidance Development of Inhalation Products
Changning Guo, PhD
Supervisory Chemist
Division of Pharmaceutical Quality Research II (DPQR II)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)