Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presentations
Totality of Evidence Including Physiologically Based Pharmacokinetic (PBPK) Modeling to Support BE Assessment and Approval of Mesalamine Delayed Release Tablets
Dr. Yang Lu
Senior Staff Fellow
Division of Bioequivalence III (DBIII)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Fang Wu, PhD
Senior 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)
Challenges and Progress in Emerging Complex Generic Oligonucleotide Products
Likan Liang, PhD
Supervisory Chemist
Division of Product Quality Assessment X (DPQA X)
Office of Product Quality Assessment II (OPQA II)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
The Journey of First Approvals of Complex Generic Long-acting Injectable Products
Yan Wang, PhD
Lead Pharmacologist / Acting Deputy Division Director
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)