GDUFA Research Outcomes

BE Methods and 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(192)
• Posters(44)
• Presentations(45)
• Papers(103)

• In Vivo Predictive Dissolution: Transport Analysis of the CO2 , Bicarbonate in Vivo Buffer System

  Krieg, Brian; Taghavi, Seyed; Amidon, Gordon; Amidon, Gregory

• A Mechanistic Physiologically-Based Biopharmaceutics Modeling (PBBM) Approach to Assess the In Vivo Performance of an Orally Administered Drug Product: From IVIVC to IVIVP

  Bermejo, Marival; Hens, Bart; Dickens, Joseph; Mudie, Deanna; Paixao, Paulo; Tsume, Yasuhiro; Shedden, Kerby; Amidon, Gordon

• Surface Area Normalized Dissolution to Study Differences in Itraconazolecopovidone Solid Dispersions Prepared by Spray-Drying and Hot Melt Extrusion

  Bhardwaj, Vivekanand; Trasi, Niraj; Zemlyanov, Dmitry; Taylor, Lynne

• Implementation of a Reference-Scaled Average Bioequivalence Approach for Highly Variable Generic Drug Products by the US Food and Drug Administration

  Davit, Barbara; Chen, Meiling; Conner, Dale; Haidar, Sam; Kim, Stephanie; Lee, Christina; Lionberger, Robert; Makhlouf, Fairouz; Nwakama, Patrick; Patel, Devvrat; Schuirmann, Donald; Yu, Lawrence

• Analysis of Diffusion-Controlled Dissolution from Polydisperse Collections of Drug Particles with an Assessed Mathematical Model

  Wang, Yanxing; Abrahamsson, Bertil; Lindfors, Lennart; Brasseur, James

• Impact of P-glycoprotein-Mediated Intestinal Efflux Kinetics on Oral Bioavailability of P-Glycoprotein Substrates

  Kwon, Hyojong; Lionberger, Robert; Yu, Lawrence

• Low Buffer Capacity and Alternating Motility along the Human Gastrointestinal Tract: Implications for in Vivo Dissolution and Absorption of Ionizable Drugs

  Hens, Bart; Tsume, Yasuhiro; Bermejo, Marival; Paixao, Paulo; Koenigsknecht, Mark; Baker, Jason; Hasler, William; Lionberger, Robert; Fan, Jianghong; Dickens, Joseph; Shedden, Kerby; Wen, Bo; Wysocki, Jeffrey; Loebenberg, Raimar; Lee, Allen; Frances, Ann

• Comparing a Bayesian Approach (BEST) with the Two One Sided Tests (TOST) for Bioequivalence Studies

  Peck, Carl; Campbell, Gregory; Yoo, Isaac; Feng, Kairui; Hu, Meng; Zhao, Liang

• Nanoscale Infrared, Thermal, and Mechanical Characterization of Telaprevir-Polymer Miscibility in Amorphous Solid Dispersions Prepared by Solvent Evaporation

  Taylor, Lynne

• CDER Risk Assessment Exercise to Evaluate Potential Risks from the Use of Nanomaterials in Drug Products

  Cruz, Celia; Tyner, Katherine; Velazquez, Lydia; Hyams, Kenneth; Jacobs, Abigail; Shaw, Arthur; Jiang, Wenlei; Lionberger, Robert; Hinderling, Peter; Kong, Yoon; Brown, Paul; Ghosh, Tapash; Strasinger, Caroline; Suarez Sharp, Sandra; Henry, Don; Uitert, Maat Van; Sadrieh, Nakissa; Morefield, Elaine