GDUFA Research Outcomes

Complex Oral Products

• All(54)
• Posters(13)
• Presentations(33)
• Papers(8)

• Bioequivalence Assessment for Long-Acting Injectables (LAIs) – FDA Regulatory Perspectives

  Jiang, Wenlei

• 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

• An Overview of Challenges and Opportunities for Innovation in Complex Generic Drug Product Development

  Jiang, Xiaohui

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

  Hu, Meng

• Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART II

  Fotaki, Nikoletta

• Model-informed Drug Development for Long-acting Injectable Products

  Fang, Lanyan (Lucy)

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• Complex Nasal Suspension PSGs: Utilization of Newly Recommended In Vitro Only Bioequivalence Option

  Boc, Susan