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(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• Physiologically Based Pharmacokinetic (PBPK) Oral Absorption Model to Predict Mucosal Permeability of Oral Cavity Drug Products

  Kalra, Priyata; Le Merdy, Maxime; Lukacova, V; Dwivedi, Pankaj; Alam, K; Tsakalozou, Eleftheria; Pauletti, G; Zhou, Haiying

• Utilizing PBPK Absorption Modeling to Evaluate Impact of Single-Sex on Bioequivalence Evaluation of Atorvastatin Immediate Release Tablets

  Cheng, Yi Hsien; Wu, Fang; Zhao, Liang; Fang, Lanyan (Lucy)

• Application of Quantitative Models to Systematically Evaluate Factors Impacting Swallowability of Tablets

  Cui, Di; Li, Karen; Al Ghabeish, Manar; Mcguire, Meredith; Sun, Wei-Jhe; Hu, Meng; Zhao, Liang; Kim, Myong – Jin

• Oral Cavity Permeability Assessment Using Sublingual and Buccal In Vitro Tissue Models

  Dwivedi, Pankaj; Alam, K; Tsakalozou, Eleftheria; Pauletti, G

• Oral Cavity Permeation of Buprenorphine Across In Vitro Models of the Buccal and Gingival Mucosa

  Dwivedi, Pankaj; Khondoker, Alam; Tsakalozou, Eleftheria; Kelchen, Megan; Pauletti, Giovanni

• Mechanistic In Vitro Oral Absorption Model to Predict Mucosal Permeability of Oral Cavity Drug Products

  Kalra, Priyata; Lukacova, Viera; Dwivedi, Pankaj; Khondoker, Alam; Tsakalozou, E; Pauletti, Giovanni; Zhou, Haiying

• Application of Physiologically Based Pharmacokinetic Modeling to Support Bioequivalence Evaluation of Mesalamine Delayed Release Tablets

  Thomas, Sherin; Wu, Fang; Zhao, Liang; Fang, Lanyan

• Identify Biopredictive Dissolution for Predicting In Vivo Performance of a BCS II Drug Product Under Fed Conditions

  Du, Ping; Fang, Lanyan; Zhao, Liang; Wu, Fang

• PBPK Modeling to Predict the Effect of Gastric pH on Bioequivalence of Dabigatran Etexilate Capsules

  Pal, Arindom; Mousa, Youssef; Fang, Lanyan; Zhao, Liang; Wu, Fang

• Formulation Effects of Marketed Oral Cavity Products on In Vitro Buccal Permeability

  Dwivedi, Pankaj; Alam, Khondoker; Tsakalozou, Eleftheria; Al Ghabeish, Manar; Pauletti, Giovanni