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)

• In Vitro Drug Release Testing for Complex Generics: A Bioequivalence Perspective

  Wang, Yan

• Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations

  Wang, Yan

• Updates to the Simcyp Simulator�۪s ADAM / M-ADAM Models

  Turner, David

• Exploiting Dual Solid State PBPK Tools to Assess the Bio(in)equivalence of Tacrolimus Amorphous Formulations with Various Degrees of Crystallization Arising During Storage

  Turner, David

• PBPK Modeling of Supersaturating Drug Products

  Turner, David

• Modeling Gastrointestinal Lumical Drug Precipitation

  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