GDUFA Research Outcomes
Injectable Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to injectable generic drug products.
-
Assessing In Vitro Drug Release from Multivesicular Liposome: Comparison of Reverse Dialysis and Rotary Shaking Methods
Manna, Soumyarwit; Petrochenko, Peter; Wu, Yong; Koo, Bonhye; Ren, Ke; Chen, Lynn; Dong, Yixuan; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby; Wang, Yan; Zheng, Jiwen
-
Assessing In Vitro Drug Release from Multivesicular Liposome: Comparison of Reverse Dialysis and Rotary Shaking Methods
Manna, Soumyarwit; Petrochenko, Peter; Wu, Yong; Dong, Yixuan; Koo, Bonhye; Chen, Lynn; Ren, Ke; Oktem, Berk; Choi, Stephanie; Xu, Xiaoming; Kozak, Darby; Wang, Yan; Zheng, Jiwen
-
Scientific Considerations for In Vitro Bioequivalence Studies of Generic Cyclosporine Ophthalmic Emulsions
Kozak, Darby; Petrochenko, Peter; Wu, Yong; Absar, Mohammad; Zheng, Jiwen; Choi, Stephanie
-
Scientific Considerations for an In Vitro Bioequivalence Approach for Ultrasound Contrast Agent Products: How Size Distribution and Total Volume of Microbubbles Affect Its Echogenicity
Koo, Bonhye; Qin, Bin; Liu, Yunbo; Wu, Yong; Choi, Stephanie; Kozak, Darby; Zheng, Jiwen
-
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