GDUFA Research Outcomes

Injectable Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to injectable generic drug products.

• All(119)
• Posters(43)
• Presentations(31)
• Papers(45)

• New Tools to Improve Complex Drug Regulation: Establishing Simple and Cost-efficient Techniques for nanoparticle Counting

  Myung, Ja-Hye; Elliott, Lindsay; Stavis, Samuel; Zheng, Jiwen; Kozak, Darby

• Cellular Pharmacokinetic/Pharmacodynamic Of Doxorubicin In A Wide Array Of Cell Lines.

  LeMerdy, Maxime; Hendriks, Bart; Cao, Yanguang

• Quantification of Drug Bound Iron, non-Transferrin Bound Iron, Transferrin Bound Iron, and Total Iron in Serum in a Rat Pharmacokinetic Study

  Matta, Murali; Beekman, Christopher; Gandhi, Adarsh; Rouse, Rodney

• Mechanistic Understanding of In Vitro Drug Release of Bupivacaine from Multivesicular Liposomes

  Manna, Soumyarwit; Petrochenko, Peter; Wu, Yong; Koo, Bonhye; Chen, Lynn; Dong, Yixuan; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby; Wang, Yan; Zheng, Jiwen

• Developing Physicochemical Characterization and In vitro Release Test Methods to Probe Drug Release Mechanism from Multivesicular Liposomes

  Manna, Soumyarwit; Wu, Yong; Petrochenko, Peter; Koo, Bonhye; Chen, Lynn; Dong, Yixuan; Xu, Xiaoming; Choi, Stephanie; Kozak, Darby; Wang, Yan; Zheng, Jiwen

• Probing Mechanism of Drug Release from Multivesicular Liposomes

  Manna, Soumyarwit; Wu, Yong; Petrochenko, Peter; Koo, Bonhye; 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; 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