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)

• Probing the Mechanism of Bupivacaine Drug Release from Multivesicular Liposomes

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

• Distinguishing Pharmacokinetics of Marketed Nanomedicine Formulations Using a Stable Isotope Tracer Assay

  Skoczen, Sarah; Snapp, Kelsie; Crist, Rachael; Kozak, Darby; Jiang, Xiaohui; Liu, Hao; Stern, Stephan

• Scientific and Regulatory Considerations for Generic Complex Drug Products Containing Nanomaterials

  Zheng, Nan; Sun, Dajun; Zou, Peng; Jiang, Wenlei

• Quantitative Analysis of Cholesterol Oxidation Products and Desmosterol in Parenteral Liposomal Pharmaceutical Formulations

  Wang, Changguang; Siriwardane, Dumindika; Jiang, Wenlei; Mudalige, Thilak

• Comparative Evaluation of US Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Biodistribution after Intravenous Dosing in Rats

  Beekman, Christopher; Matta, Murali; Thomas, Christopher; Mohammad, Adil; Stewart, Sharron; Xu, Lin; Chockalingam, Ashok; Shea, Katherine; Sun, Dajun; Jiang, Wenlei; Patel, Vikram; Rouse, Rodney

• Regulatory Research Supporting the Development of Drug Products Containing Nanomaterials A US-FDA Perspective

  Tyner, Katherine

• Nanomedicine Pharmacokinetics and Bioanalytical Methods to Measure Drug Release

  Stern, Stephan

• Advances in Iron Colloid Products: Product-Specific Guidance Discussion

  Jiang, Wenlei

• Complex Drug Products Containing Nanomaterials

  Jiang, Wenlei

• Regulatory Uses of IVRT Studies on Complex Generic Ophthalmic, Injectable, Implantable, and Inserted Products

  Qin, Bin