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)

• Dissolution and Translational Modeling Strategies Toward Establishing an In Vitro-In Vivo Link-a Workshop Summary Report

  Heimbach, Tycho; Suarez Sharp, Sandra; Kakhi, Maziar; Holmstock, Nico; Olivares Morales, Andres; Pepin, Xavier; Sjogren, Erik; Tsakalozou, Eleftheria; Seo, Paul; Li, Min; Zhang, Xinyuan; Lin, Hopi; Montague, Timothy; Mitra, Amitava; Morris, Denise; Patel, N; Kesisoglou, F

• Dissolution Performance of Binary Amorphous Drug Combinations–Impact of a Second Drug on the Maximum Achievable Supersaturation

  Taylor, Lynne

• Modeling and Simulation of the Effect of Proton Pump Inhibitors on Magnesium Homeostasis. 1. Oral Absorption of Magnesium

  Bai, Jane; Hausman, Ethan; Lionberger, Robert; Zhang, Xinyuan

• The activities of drug inactive ingredients on biological targets

  Pottel, Joshua; Armstrong, Duncan; Zou, Ling; Fekete, Alexander; Huang, Xiping; Torosyan, Hayarpi; Bednarczyk, Dallas; Whitebread, Steven; Bhhatarai, Barun; Liang, Guiqing; Jin, Hong; Ghaemi, Nassir; Slocum, Samuel; Lukacs, Katalin; Irwin, John; Berg, Ell

• 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