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)

• Innovative Approaches for Demonstration of Bioequivalence: the US FDA Perspective

  Zhang, Xinyuan; Zheng, Nan; Lionberger, Robert; Yu, Lawrence

• A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption

  Martinez, M N; Sinko, B; Wu, F; Flanagan, T; Borbas, E; Tsakalozou, Eleftheria; Giacomini, K M

• Bacterial metabolism rescues the inhibition of intestinal drug absorption by food and drug additives

  Zou, Ling; Spanogiannopoulos, Peter; Peiper, Lindsey; Chein, Huan Chieh; Cai, Wenlong; Khuri, Natalia; Pottel, Joshua; Vora, Bianca; Ni, Zhanglin; Tsakalozou, Eleftheria; Zhang, Wenjun; Schoichet, Brian; Giacomini, Kathleen; Turnbaugh, Peter

• Prevalence and Predictors of Generic Drug Skepticism among Physicians: Results of a National Survey

  Kesselheim, Aaron; Gagne, Joshua; Eddings, Wesley; Franklin, Jessica; Ross, Kathryn; Fulchino, Lisa; Campbell, Eric

• Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation

  Zhang, Xinyuan

• Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography-Inductively Coupled Plasma- Mass Spectrometric Approach

  Neu, Heather; Alexishin, Sergei; Brandis, Joel; Williams, Anne; Li, Wenjing; Sun, Dajun; Zheng, Nan; Jiang, Wenlei; Zimrin, Ann; Fink, Jeffrey; Polli, James; Kane, Maureen; Michel, Sarah

• Interactions of Oral Molecular Excipients with Breast Cancer Resistance Protein, BCRP

  Zou, Ling; Pottel, Joshua; Khuri, Natalia; Ngo, Huy; Ni, Zhanglin; Tsakalozou, Eleftheria; Warren, Mark; Huang, Yong; Schoichet, Brian; Giacomini, Kathleen

• The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers

  Alan, Parr; Hidalgo, Ismael; Bode, Chris; Brown, William; Yazdanian, Mehran; Gonzalez, Mario; Sagawa, Kazuko; Miller, Kevin; Jiang, Wenlei; Stippler, Erika

• Investigating the Impact of Drug Crystallinity in Amorphous Tacrolimus Capsules on Pharmacokinetics and Bioequivalence Using Discriminatory in Vitro Dissolution Testing and PBPK Modeling and Simulation

  Purohit, Hitesh; Trasi, Niraj; Sun, Dajun; Chow, Edwin; Wen, Hong; Zhang, Xinyuan; Gao, Yi; Taylor, Lynne

• Modeling and Mechanistic Approaches for Oral Absorption: Quality by Design in Action

  Yu, Lawrence; Zhang, Xinyuan; Lionberger, Robert