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.
-
Role of Biopredictive Dissolution and Oral PBPK to Evaluate the Impact of Food on Drug Absorption
Al-Gousous, Jozef; Langguth, P
-
Excipient Safety Assessment in Generic Drug Formulations: An Overview
Agarwal, Stuti
-
Expectations and Common Deficiencies for IVRT Studies Submitted in ANDAs for Ophthalmic Emulsion Products
Abuznait, Alaa
-
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