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)

• Changes in Drug Crystallinity in a Commercial Tacrolimus Amorphous Formulation Result in Variable Pharmacokinetics

  Taylor, LS; Trasi, Niraj; Purohit, HS; Sun, D; Kinjo, Minori; Ni, Zhanglin; Mahjabeen, Sanjida; Feng, Karui Kevin; Sun, Wei-Jhe; Matta, Murali K; Decker, Brian; Galinsky, Raymond E

• Designs of Clinical Swallowability Assessments of Solid Oral Dosage Forms in Regulatory Submissions

  Mcguire, Meredith; Mostofa, Agm; Shon, Jihong; Frost, Mitchell; Kim, Myong-Jin; Li, Karen

• The Effect of Food Vehicles on In Vitro Performance of Pantoprazole Sodium Delayed Release Sprinkle Formulation

  Wu, Kai-Wei; Zheng, Kai; Tian, Li; Xia, Li; Hwang, Sung Yong; Nwakama, Patrick E; Sun, Wei Jhe; Kim, Myong Jin; Tampal, N; Xu, Xiaoming; Boyce, Heather; Feng, Xin

• Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations: a Carbamazepine Case Study

  Pawar, Gopal; Wu, Fang; Zhao, Liang; Fang, Lanyan; Burckart, Gilbert; Feng, Kairui; Mousa, Youssef; Al Shoyaib, Abdullah; Jones, Marie-Christine; Batchelor, Hannah

• 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

• 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

• 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

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

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

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

  Trasi, Niraj; Purohit, Hitesh; Taylor, Lynne

• 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