GDUFA Research Outcomes

MR Oral Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to modified release generic drug products.

• All(66)
• Posters(31)
• Presentations(24)
• Papers(11)

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

  Tan, Ming-Liang

• Bioequivalence for Oral Locally Acting Gastrointestinal Drug Products

  Sun, Wei-Jhe

• Generic Oral Modified Release Drug Products: Establishing Bioequivalence for Additional Strengths

  Sun, Wei Jhe; Wang, Rong

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

  Shoyaib, Abdullah

• Modeling for Success: A Case Example for Oseltamivir Phosphate

  Mousa, Youssef

• Scientific Foundations for Development of Generic MR Oral Products

  Lionberger, Robert

• Establishing Bioequivalence for Generic Oral Modified-Release Products: Regulatory Considerations and Utility of In Vivo Predictive Dissolution

  Lee,Sue-Chih

• 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