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)

• Mechanistic Analysis of Triamcinolone Acetonide Release from PLGA Microspheres as a Function of Varying in Vitro Release Conditions

  Doty, Amy; Zhang, Ying; Weinstein, David; Wang, Yan; Choi, Stephanie; Qu, Wen; Mittal, Sachin; Schwendeman, Steven

• Exploring Gastrointestinal Variables Affecting Drug and Formulation Behavior: Methodologies, Challenges and Opportunities

  Hens, Bart; Corsetti, Maura; Spiller, Robin; Marciani, Luca; Vanuytsel, Tim; Tack, Jan; Talattof, Arjang; Amidon, Gordon; Koziolek, Mirko; Weitschies, Werner; Wilson, Clive; Bennink, Roelof; Brouwers, Joachim; Augustijns, Patrick

• Physiologically Based Pharmacokinetic and Absorption Modeling for Osmotic Pump Products

  Ni, Zhanglin; Talattof, Arjang; Fan, Jianghong; Tsakalozou, Eleftheria; Sharan, Satish; Sun, Duxin; Wen, Hong; Zhao, Liang; Zhang, Xinyuan

• Evaluation of the Crystallization Tendency of Commercially Available Amorphous Tacrolimus Formulations Exposed to Different Stress Conditions

  Trasi, Niraj; Purohit, Hitesh; Taylor, Lynne

• Dissolution Test of Tacrolimus Capsule: Effects of Filtration and Glass Adsorption

  Zeng, Kui; Gao, Zongming; Trehy, Michael; Jiang, Wenlei

• Switch-Backs Associated with Generic Drugs Approved Using Product-Specific Determinations of Therapeutic Equivalence

  Gagne, Joshua; Polinski, Jennifer; Jiang, Wenlei; Dutcher, Sarah; Xie, Jing; Lii, Joyce; Fulchino, Lisa; Kesselheim, Aaron

• 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