GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(127)
• Posters(7)
• Presentations(111)
• Papers(9)

• PBPK Models: Opportunities for Enhancements

  Jusko, William

• 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

• Overview of Complex Generics Regulatory Perspective on Bioequivalence

  Jiang, Jeff

• PBPK Modeling to Support Risk Assessment for Oral Drug Products, Including Waiver of Fed BE Studies

  Jereb, Rebeka

• PBPK Modeling for Different Locally-Administered Drug Products

  Jereb, Rebeka

• Establishing Bioequivalence Using Characterization Based Approaches for Topical Products – Challenges & Solutions

  Jani, Romit

• Use of PBPK in New Drug Development and Regulatory Review – Clinical Pharmacology Perspective

  Huang, Shiew-Mei

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

  Hu, Meng