GDUFA Research Outcomes

Complex Oral Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the oral route, including buccal and locally-acting gastrointestinal products.

• All(41)
• Posters(5)
• Presentations(28)
• Papers(8)

• Review of Complex Generic Drugs Delivered Through the Female Reproductive Tract: The Current Competitive Landscape and Emerging Role of Physiologically Based Pharmacokinetic Modeling to Support Development and Regulatory Decisions

  Donnelly, Mark; Tsakalozou, Eleftheria; Sharan, Satish; Straubinger, Thomas; Bies, Robert; Zhao, Liang

• Mechanistic Fluid Transport Model to Estimate Gastrointestinal Fluid Volume and Its Dynamic Change over Time

  Yu, Alex; Jackson, Trachette; Tsume, Yasuhiro; Koenigsknecht, Mark; Wysocki, Jeffrey; Marciani, Luca; Amidon, Gordon; Frances, Ann; Baker, Jason; Hasler, William; Wen, Bo; Pai, Amit; Sun, Duxin

• Development and Validation of an Ion Chromatography Method for the Determination of Phosphate-Binding of Lanthanum Carbonate

  Samy, Raghu; Faustino, Patrick; Adams, Wallace; Yu, Lawrence; Khan, Mansoor; Yang, Yongsheng

• Measurement of in vivo Gastrointestinal Release and Dissolution of Three Locally Acting Mesalamine Formulations in Regions of the Human Gastrointestinal Tract

  Yu, Alex; Baker, Jason; Fioritto, Ann; Wang, Ying; Luo, Ruijuan; Li, Siwei; Wen, Bo; Bly, Michael; Tsume, Yasuhiro; Koenigsknecht, Mark

• Evaluation of the In Vitro Efficacy of Sevelamer Hydrochloride and Sevelamer Carbonate

  Yang, Yongsheng; Mohammad, Adil; Berendt, Robert; Carlin, Alan; Khan, Mansoor; Faustino, Patrick

• In Vivo Predictive Dissolution: Comparing the Effect of Bicarbonate and Phosphate Buffer on the Dissolution of Weak Acids and Weak Bases

  Krieg, Brian; Taghavi, Seyed; Amidon, Gordon; Amidon, Gregory

• 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

• Impact of Particle Flocculation on the Dissolution and Bioavailability of Injectable Suspensions

  Smith, William; Bae, Jungeun; Zhang, Ying; Qin, Bin; Wang, Yan; Kozak, Darby; Ashraf, Muhammad; Xu, Xiaoming

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

  Zhao, Liang

• Leveraging Modeling and Simulation to Make Regulatory Impacts for Long-Acting Generic Drug Approvals

  Zhao, Liang