GDUFA Research Outcomes

BE Methods & Analyses

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

• All(251)
• Posters(64)
• Presentations(67)
• Papers(120)

• A Quasi-3D Wire Approach to Model Pulmonary Airflow in Human Airways

  Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• Summary of the In Vivo Predictive Dissolution (iPD) – Oral Drug Delivery (ODD) Conference 2018

  Hens, Bart; Al Gousous, Jozef; Wang, Kai; Salehi, Niloufar; Ziff, Robert; Tsume, Yasuhiro; Bermejo Sanz, Marival; Paixao, Paulo; Brasseur, James; Yu, Alex; Talattof, Arjang; Benninghoff, Gail; Langguth, Peter; Lennernas, Hans; Hasler, William; Marciani, L

• Nanometer-Scale Residual Crystals in a Hot Melt Extruded Amorphous Solid Dispersion: Characterization by Transmission Electron Microscopy

  Moseson, Dana; Mugheirbi, Naila; Stewart, Andrew; Taylor, Lynne

• Dissolution of Indomethacin Crystals into a Polymer Melt: Role of Diffusion and Fragmentation

  Moseson, Dana; Parker, Andrew; Gilpin, Christopher; Stewart, Andrew; Beaudoin, Stephen; Taylor, Lynne

• Gastrointestinal Motility Variation and Implications for Plasma Level Variation: Oral Drug Products

  Talattof, Arjang; Price, Judy; Amidon, Gordon

• Linking the Gastrointestinal Behavior of Ibuprofen with the Systemic Exposure between and within Humans-Part 2: Fed State

  Paixao, Paulo; Bermejo, Marival; Hens, Bart; Tsume, Yasuhiro; Dicken, Joseph; Shedden, Kerby; Salehi, Niloufar; Koenigsknecht, Mark; Baker, Jason; Hasler, William; Lionberger, Robert; Fan, Jianghong; Wysocki, Jeffrey; Wen, Bo; Lee, Allen; Frances, Ann; Amidon, G E; Yu, A; Benninghoff, G; Lobenberg, R; Talattof, A; Su, D; Amidon, G L

• Effect of Common Excipients on the Oral Drug Absorption of Biopharmaceutics Classification System Class 3 Drugs Cimetidine and Acyclovir

  Vaithianathan, Soundarya; Haidar, Sam; Zhang, Xinyuan; Jiang, Wenlei; Avon, Christopher; Dowling, Thomas; Shao, Changxing; Kane, Maureen; Hoag, Stephen; Flasar, Mark; Ting, Tricia; Polli, James

• Interactions of Azo Dyes Commonly Used in Oral Drug Products with the Organic Anion Transporting Polypeptide 2B1 (OATP2B1) and Human Gut Bacteria

  Zou, Ling

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang