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(57)
• Posters(15)
• Presentations(33)
• Papers(9)

• 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

• Q1 and Q2 Recommendations: Sucralfate Oral Suspension

  Al Ghabeish, Manar

• 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

• 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

• Using PBPK to Establish In Vitro-In Vivo Relationship for Budesonide Delayed Release Oral Drug Product

  Amaral Silva, D; Zhou, Haiying; Wu, Fang; Fotaki, Nikoletta; Pereira Garrastazu, Gabriela; Lukacova, V

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

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