GDUFA Research Outcomes
Injectable Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to injectable generic drug products.
-
Characterizing How Size Distribution and Concentration Affect Echogenicity of Ultrasound Contrast Agent Products: Scientific Considerations for an In Vitro Bioequivalence Approach
Koo, Bonhye; Qin, Bin; Liu, Yunbo; Wu, Yong; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen
-
Characterization of Paclitaxel and Albumin Oligomeric Status in Abraxane during Storage
Jiang, Wenlei
-
A Statistical Bioequivalence Approach Based on Earth Mover’s Distance for Equivalence Testing of Particle Size Distribution
Hu, Meng; Jiang, Xiaohui; Absar, Mohammad; Choi, Stephanie; Shen, Meiyu; Weng, Yuting; Zhao, Liang; Lionberger, Robert
-
Integrating Cellular Disposition Of Doxorubicin Into A Multiscale Physiologically Based Pharmacokinetic Model In Mice And Scale-Up To Humans.
He, Hua; Wu, Yun; Liu, Can; Cao, Yanguang
-
Novel Drug Release Profiling Method for Albumin-Bound Paclitaxel Nanoparticle Drug Products
Gamage, Prabhath; Yurtsever, Fatma; Jiang, Wenlei; Mudalige, Thilak
-
Dexamethasone Intravitreal Implants: Manufacture, Characterization, and Elucidation of Drug Release Mechanism
Costello, Mark; Zhang, Feng; Liu, Joseph; Chen, Beibei; Wang, Yan; Qin, Bin
-
Determining the Bio-distribution of Colloidal Iron Drug Products in Rats by Inductively Coupled Plasma Mass Spectrometry (ICP-MS)
Beekman, Christopher; Matta, Murali; Mohammad, Adil; Gandhi, Adarsh; Sun, Dajun; Jiang, Wenlei; Lionberger, Robert; Rouse, Rodney; Patel, Vikram
-
Impact of Manufacturing Process on Critical Quality Attributes of Multivesicular Liposomes
Bae, Jungeun; Patel, Mehulkumar; Manna, Soumyarwit; Smith, William; Vo, Anh; Wang, Yan; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen; Xu, Xiaoming
-
Scientific Considerations for Generic Cyclosporine Ophthalmic Emulsion In Vitro Bioequivalence Studies
Absar, Mohammad; Petrochenko, Peter; Choi, Stephanie