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)

• Regulatory Research on the Effect of Excipients on Drug Absorption

  Zhang, Lei

• Hydrodynamic Enhancement of Dissolution from Drug Particles: In Vivo vs. In Vitro

  Brasseur, James.; Wang, Yanxing

• Essential Elements of BCS III-Based Biowaiver Request

  Zhang, Yi

• Biopharmaceutics Classification System Class 3 Waiver

  Zhang, Yi

• Computational Studies of Drug Release, Transport, and Absorption in the Human Intestines

  Gong, Yuqing

• In Vivo Predictive Dissolution (iPD) to Advance Oral Drug Product Development

  Amidon, Gordon

• New Scientific Directions in Oral Bioequivalence(BE)

  Amidon, Gordon

• Advancing the Science of Oral Solid Dosage Form Development and Performance

  Amidon, G

• Interactions of Oral Molecular Excipients with Breast Cancer Resistance Protein, BCRP

  Zou, Ling; Pottel, Joshua; Khuri, Natalia; Ngo, Huy; Warren, Mark; Huang, Yong; Schoichet, Brian; Giacomini, Kathleen

• Bacterial Metabolism Rescues the Inhibition of Intestinal Drug Absorption by Food and Drug Addictives

  Zou, Ling; Spanogiannopoulos, Peter; Chien, Huan-Chieh; Pieper, Lindsey; Cai, Wenlong; Khuri, Natalia; Pottel, Joshua; Vora, Bianca; Ni, Zhanglin; Tsakalozou, Eleftheria; Zhang, Wenjun; Shoichet, Brian; Turnbaugh, Peter; Giacomini, Kathleen