Back to: Advancing Generic Drug Development: Translating Science to Approval 2024
Presentations
IVRT Methods for In Situ Depot-Forming Long-Acting Injectable Products
Agm (Abu) Mostofa, PhD
Pharmacologist
Division of Bioequivalence I (DBI)
Office of Bioequivalence (OB)
Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Nano-Size Complex Products In Vitro Release Testing (IVRT)
Thilak Mudalige, PhD
Research Chemist
Arkansas Human & Animal Food Laboratory (ARLHAF)
Office of Human & Animal Food Laboratory Operations (OHAFLO)
Office of Regulator Science (ORS)
Office of Regulatory Affairs (ORA)
US Food and Drug Administration (FDA)
Application of Adaptive Perfusion as In Vitro Release Testing Method to Improve Understanding and Assessment of Complex Drug Products
Dongkai Zhu, PhD
Visiting Associate
Division of Pharmaceutical Quality Research VI (DPQR VI)
Office of Pharmaceutical Quality Research (OPQR)
Office of Pharmaceutical Quality (OPQ)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)