GDUFA Research Outcomes

Complex Oral Products

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the oral route, including buccal and locally-acting gastrointestinal products.

• All(41)
• Posters(5)
• Presentations(28)
• Papers(8)

• In Vivo Relevance of Dissolution

  Jiang, Wenlei

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

  Jiang, Wenlei

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

  Hu, Meng

• Bioequivalence of Polymeric Long Acting Drugs

  Wang, Yan

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

  Fang, Lanyan (Lucy)

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• Evaluation of U.S. FDA Approved Generic Oral Solution Products

  Hakeem, Susan; Huang, Yih-Chain; Jiang, Wenlei

• Contrasting Regional Availability Of Different Mesalamine Products In The Gastrointestinal Tract In Healthy Humans Using A Novel Multi-Port Luminal Aspiration System And Correlation With Systemic Absorption.

  Fioritto, Ann; Baker, Jason; Collins, Kristen; Wen, Bo; Wang, Ying; Luo, Ruijuan; Bleske, Barry; Johnson, Mark; Koenigsknecht, Mark; Hasler, William; Sun, Duxin

• Development of an in-Vitro Protein Binding Method for the Evaluation of Bioequivalence of Sucralfate Suspension

  Feng, Xin; Al-Ghabeish, Manar; Lionberger, Robert; Cruz, Celia; Ashraf, Muhammad

• A Novel Method To Investigate Local Concentrations Of Mesalamine In The Gastrointestinal Tract Of Healthy Volunteers.

  Brown, Sara; Bly, Michael; Baker, Jason; May, Kristen; Fioritto, Ann; Hasler, William; Sun, Duxin