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)

• Interaction of Commonly Used Oral Molecular Excipients with P-glycoprotein

  Bajaj, Ruchika; Chong, Lisa; Zou, Ling; Tsakalozou, Eleftheria; Ni, Zhanglin; Giacomini, Kathleen; Kroetz, Deanna

• In Vitro Dissolution Methodology, Mini-Gastrointestinal Simulator (mGIS), Predicts Better in Vivo Dissolution of a Weak Base Drug, Dasatinib

  Tsume, Yasuhiro; Takeuchi, Susumu; Matsui, Kazuki; Amidon, Gregory; Amidon, Gordon

• Unmet Needs: Research Helps Regulators do Their Jobs

  Altman, Russ; Khuri, Natalia; Salit, Marc; Giacomini, Kathleen

• Development of a Pediatric Relative Bioavailability/Bioequivalence Database and Identification of Putative Risk Factors Associated With Evaluation of Pediatric Oral Products

  Pawar, Gopal; Wu, Fang; Zhao, Liang; Fang, Lanyan; Burckart, Gilbert; Feng, Kairui; Mousa, Youssef; Naumann, Franci; Batchelor, Hannah

• Metabolism of Bupropion by Carbonyl Reductases in Liver and Intestine

  Connarn, Jamie; Zhang, Xinyuan; Babiskin, Andrew; Sun, Duxin

• Pharmaceutical Aerosols Deposition Patterns from a Dry Powder Inhaler: Euler Lagrangian Prediction and Validation

  Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• A Quasi-3D Wire Approach to Model Pulmonary Airflow in Human Airways

  Kannan, Ravishekar; Chen, Zhijian; Singh, Narender; Przekwas, Andrzej; Delvadia, Renishkumar; Tian, Geng; Walenga, Ross

• Summary of the In Vivo Predictive Dissolution (iPD) – Oral Drug Delivery (ODD) Conference 2018

  Hens, Bart; Al Gousous, Jozef; Wang, Kai; Salehi, Niloufar; Ziff, Robert; Tsume, Yasuhiro; Bermejo Sanz, Marival; Paixao, Paulo; Brasseur, James; Yu, Alex; Talattof, Arjang; Benninghoff, Gail; Langguth, Peter; Lennernas, Hans; Hasler, William; Marciani, L

• Nanometer-Scale Residual Crystals in a Hot Melt Extruded Amorphous Solid Dispersion: Characterization by Transmission Electron Microscopy

  Moseson, Dana; Mugheirbi, Naila; Stewart, Andrew; Taylor, Lynne

• Dissolution of Indomethacin Crystals into a Polymer Melt: Role of Diffusion and Fragmentation

  Moseson, Dana; Parker, Andrew; Gilpin, Christopher; Stewart, Andrew; Beaudoin, Stephen; Taylor, Lynne