GDUFA Research Outcomes

IR Oral Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to immediate release generic drug products.

• All(31)
• Posters(10)
• Presentations(14)
• Papers(7)

• Food Effect and Formulation: How Soluble Fillers Affect the Disintegration and Dissolution of Tablets in Viscous Simulated Fed State Media

  Umer, MF; Stahl, V; Al-Gousous, J; Nawroth, T; Sun, WJ; Wu, F; Jiang, W; Gao, Z; Langguth, P

• A Physiologically Based Biopharmaceutics Modeling (PBBM) Framework for Characterizing Formulation-Dependent Food Effects: Paving the Road towards Fed Virtual BE Studies for Itraconazole Amorphous Solid Dispersions

  Rudolph, Niklas; Charbe, Nitin; Plano, David; Al Shoyaib, Abdullah; Pal, Arindom; Boyce, Heather; Zhao, Liang; Wu, Fang; Polli, James; Dressman, Jennifer; Cristofoletti, Rodrigo

• Global Harmonization of Immediate-Release Solid Oral Drug Product Bioequivalence Recommendations and the Impact on Generic Drug Development

  Kotsybar, Joseph; Hakeem, Susan; Zhang, Lei; Jiang, Wenlei; Jhon, Young Kuk

• 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

• Development and Validation of a HPLC Method for Dissolution and Stability Assay of Liquid-Filled Cyclosporine Capsule Drug Products

  Xu, Xiaoming; Sayeed, Vilayat; Khan, Mansoor

• Development of In Vitro Dissolution Testing Methods to Simulate Fed Conditions for Immediate Release Solid Oral Dosage Forms

  Lex, Timothy; Rodriguez, Jason; Zhang, Lei; Jiang, Wenlei; Gao, Zongming

• Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation: Report of an FDA Public Workshop

  Zhang, Xinyuan; Duan, John; Kesisoglou, Filippos; Novakovic, Jasmina; Amidon, Gordon; Jamei, Masoud; Lukacova, Viera; Eissing, Thomas; Tsakalozou, Eleftheria; Zhao, Liang; Lionberger, Robert

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang

• FEV1 Based Bioequivalence Study for Inhaled Corticosteroids

  Zhao, Liang

• Use of Modeling and Simulation to Support New BE Approaches

  Zhao, Liang