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)

• A Real-Time NMR Method for Measurement of In Vitro Aggregation Kinetics of Degarelix Drug Products

  Patil, Sharadrao; Qin, Bin; Wang, Yan; Ahmed, Snober; Yilmaz, Huzeyfe; Jiang, Xiaohui; Keire, David; Chen, Kang

• Mechanistic Model and Analysis of Doxorubicin Release from Liposomal Formulations

  Fugit, Kyle; Xiang, Tianxiang; Choi, Du; Kangarlou, Sogol; Csuhai, Eva; Bummer, Paul; Anderson, Bradley

• Evaluation of Size-Based Distribution of Drug and Excipient in Amphotericin B Liposomal Formulation

  Haute, Desiree; Jiang, Wenlei; Mudalige, Thilak

• Comparative Evaluation of US Brand and Generic Intravenous Sodium Ferric Gluconate Complex in Sucrose Injection: Physicochemical Characterization

  Sun, Dajun; Rouse, Rodney; Patel, Vikram; Wu, Yong; Zheng, Jiwen; Karmakar, Alokita; Patri, Anil; Chitranshi, Priyanka

• Evaluation of the Physicochemical Properties of the Iron Nanoparticle Drug Products: Brand and Generic Sodium Ferric Gluconate

  Brandis, Joel; Kihn, Kyle; Taraban, Marc; Schnorr, Julia; Confer, Alex; Batelu, Sharon; Sun, Dajun; Rodriguez, Jason; Jiang, Wenlei; Goldberg, David; Langguth, Peter; Stemmler, Timothy; Yu, Yihua; Kane, Maureen; Polli, James; Michel, Sarah

• Physicochemical Surrogates for In Vitro Toxicity Assessment of Liposomal Amphotericin B

  Marx, Richard; Lee, Jaeweon; Svirkin, Yuri; Yoon, Seongkyu; Landrau, Nelson; Kaisar, Md Abul; Qin, Bin; Park, Jin H; Alam, Khondoker; Kozak, Darby; Wang, Yan; Xu, Xiaoming; Xu, Zheng, Jiwen; Rivnay, Benjamin

• Performance of Redox Active and Chelatable Iron Assays to Determine Labile Iron Release from Intravenous Iron Formulations

  Pai, Amy; Meyer, Dan; Bales, Brian; Cotero, Victoria; Pai, Manjunath; Zheng, Nan; Jiang, Wenlei

• Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: BDrug Products, Including Biological Products, that Contain Nanomaterials

  Vlieger, Jon; Crommelin, Daan; Tyner, Katherine; Drummond, Daryl; Jiang, Wenlei; Mcneil, Scott; Neervannan, Sesha; Crist, Rachael; Shah, Vinod

• Characterization of Complex Drug Formulations using Cryogenic Scanning Electron Microscopy (Cryo-SEM)

  Liang, J; Koo, B; Wu, Y; Manna, S; Noble; M; Kozak, D; Wang, Y; Zheng, J

• An NMR Protocol for In Vitro Paclitaxel Release from an Albumin-Bound Nanoparticle Formulation

  Suh, Minsung; Patil, Sharadrao; Kozak, Darby; Pang, Eric; Choi, Stephanie; Jiang, Xiaohui; Rodriguez, Jason; Keire, David; Chen, Kang