Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presentations
Current Trends in Product-Specific Guidance (PSG) Development & Revisions for Topical Products
Megan Kelchen, PhD
Senior Pharmacologist
Division of Therapeutic Performance I (DTP-I)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Enhanced Understanding of Structure Performance Relationship Using Modeling and Simulation- A Case Study with Dapsone Topical Gel
Eleftheria Tsakalozou, PhD
Lead Pharmacologist
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)
Approaches for Evaluation of Formulation Differences on Performance of Topical Products
Tannaz Ramezanli, PhD, PharmD
Senior Pharmacologist
Division of Therapeutic Performance I (DTP-I)
Office of Research and Standards (ORS)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)