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)

• 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

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef

• Modeling for Success: A Case Example for Oseltamivir Phosphate

  Mousa, Youssef

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei

• In Vivo Relevance of Dissolution

  Jiang, Wenlei

• Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment

  Jiang, Wenlei

• Influence of Non-homogeneous Particle Distributions on Drug Release in a Couette In vitro Dissolution Device

  Jayaraman, Balaji; Brasseur, James; Wang, Yanxing

• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach

  Hu, Meng