GDUFA Research Outcomes

Nanotechnology Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to generic products that contain nanomaterials or nanotechnology (e.g., colloidal iron-carbohydrate and liposomal products).

• All(59)
• Posters(15)
• Presentations(25)
• Papers(19)

• Orthogonal and Complementary Measurements of Properties of Drug Products Containing Nanomaterials

  Simon, C G; Borgos, S E; Calzolai, L; Nelson, B C; Parot, J; Petersen, E J; Roesslein, M; Xu, X; Caputo, F

• Scanning Electron-Raman Cryomicroscopy for Characterization of Nanoparticle-Albumin Drug Products

  Yilmaz, Huzeyfe; Ahmed, S; Rodriguez, Jason D; Willett, Daniel R

• Topical Pharmacokinetics of Brinzolamide Suspensions in Rabbits and Variability Analysis for Sample Size and Design Considerations

  Naageshwaran, Vatsala; Bigonne, Helene; Gum, Glenwood; Malla, Spundana; Sol, Charity Del; Bon, Charles; Xu, Xiamoning; Vo, Anh; Smith, William; Beringhs, Andre O’reilly; Kozak, Darby; Tan, Mingliang; Babiskin, Andrew; Babiskin, Andrew; Urtti, Arto; Amo, Eva Del; Ranta, Veli Pekka

• Multiphase Drug Distribution and Exchange in Oil-in-Water Nanoemulsion Revealed by High-Resolution 19F qNMR

  Wang, Deyun; Park, Jin H; Zheng, Jiwen; Cai, Bing; Keire, David; Chen, Kang

• Adaptive Perfusion: An In Vitro Release Test (IVRT) for Complex Drug Products

  Patel, Deval; Zhang, Ying; Dong, Yixuan; Qu, Haiou; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

• Injectable, Long-Acting PLGA Formulations: Analyzing PLGA and Understanding Microparticle Formation

  Park, Kinam; Skidmore, Sarah; Hadar, Justin; Garner, John; Park, Haesun; Otte, Andrew; Soh, Bong Kwan; Yoon, Gwangheum; Yu, Dijia; Yun, Yeonhee; Lee, Byung Kook; Jiang, Xiaohui; Wang, Yan

• Report of the AAPS Guidance Forum on the FDA Draft Guidance for Industry: BDrug Products, Including Biological Products, that Contain Nanomaterials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

• Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

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

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

• Product-Specific Guidance Development for Patisiran Sodium Intravenous Solution

  Zhang, Deyi; Bin, Qin; Wang, Yan