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.
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Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment
Mousa, Youssef
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Modeling for Success: A Case Example for Oseltamivir Phosphate
Mousa, Youssef
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Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices
Jiang, Wenlei
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In Vivo Relevance of Dissolution
Jiang, Wenlei
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Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment
Jiang, Wenlei
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Influence of Non-homogeneous Particle Distributions on Drug Release in a Couette In vitro Dissolution Device
Jayaraman, Balaji; Brasseur, James; Wang, Yanxing
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Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach
Hu, Meng
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Development of PBPK Model for Predicting Food Impact on BE Assessment
Shoyaib, Abdullah
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Alternative Model-Based Data Analysis Approach to Demonstrate Bioequivalence
Gong, Yuqing
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The Effects of Excipients on Intestinal Drug Transporters
Giacomini, Kathy