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)

• Development of Generic Drug products under Suitability Petition

  Boyce, Heather

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

  Brasseur, James.; Wang, Yanxing

• A Review of Internal Data on Bioequivalence Studies Conducted with Soft Food Administration

  Boyce, Heather

• Impact of Excipients on Drug Permeation to Support Biowaivers for Non-Q1/Q2 Products

  Bode, Chris

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

  Gong, Yuqing

• Screening Oral Excipients against P-glycoprotein

  Bajaj, Ruchika

• Biopharmaceutic In Vitro In Vivo Extrapolation (IVIV_E) Informed Physiologically-Based Pharmacokinetic Model of Ritonavir Norvir Tablet Absorption in Humans Under Fasted and Fed State Conditions

  Arora, Sumit

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

  Amidon, G

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

  Amidon, Gordon

• New Scientific Directions in Oral Bioequivalence(BE)

  Amidon, Gordon