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(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• Modeling Gastrointestinal Lumical Drug Precipitation

  Turner, David

• PBPK Modeling of Supersaturating Drug Products

  Turner, David

• A Critical Overview of the Biological Effects of Excipients (Part I): Impact on Gastrointestinal Absorption

  Giacomini, Kathy; Tsakalozou, Eleftheria

• Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling

  Tan, Ming-Liang

• A Dynamic Bile Salt Model to Predict Bile Salt Disposition within the GI Luminal Fluids

  Stamatopoulos, Konstantinos

• In Silico Tools to Simulate the Regional Differences of the Human GI Tract

  Stamatopoulos, Konstantinos

• Development of PBPK Model for Predicting Food Impact on BE Assessment

  Shoyaib, Abdullah

• Consideration Factors on Study Population Selection for Bioequivalence Studies with Pharmacokinetic Endpoints

  Shon, Jihong

• Amphotericin B Liposome: Revisions of the Product Specific Guidance

  Qin, Bin

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef