GDUFA Research Outcomes
MR Oral Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to modified release generic drug products.
-
Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach
Hu, Meng
-
Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation
Fan, Jianghong
-
Establishing Bioequivalence for “Additional Strengths” of Oral Modified-Release Drug Products
Boyce, Heather
-
Impact of Excipients on Drug Permeation to Support Biowaivers for Non-Q1/Q2 Products
Bode, Chris
-
Q1 and Q2 Recommendations: Sucralfate Oral Suspension
Al Ghabeish, Manar
-
Effect of Omeprazole Administration on the Pharmacokinetics of Oral Extended-release Nifedepine: Physiologically based Pharmacokinetic Modeling
Tan, Mingliang; Gao, Zongming; Babiskin, Andrew; Kim, Myong Jin; Fang, Lanyan; Zhang, Lei; Zhao, Liang
-
A Science-based Approach for Recommendation of Antagonist Blockade in the Bioequivalence Studies of Opioid Drug Products
Oh, Christine; Mostofa, Agm; Natarajan, Karthika; Sun, Wei-Jhe; Boyce, Heather J; Kim, Myong Jin
-
In Vitro Evaluation of Two Morphine Sulfate Extended-Release Products Sprinkled on Soft Foods
Rana, Md Sohel; Feng, Xin; Sun, Wei-Jhe; Xia, Li; Nwakama, Patrick; Kim, Myong Jin; Tampal, Nilufer; Boyce, Heather; Tian, Li
-
Ethanol Solubility of Rate Controlling Polymer in Modified Release Formulation Can Impact Alcohol Dose Dumping: An Assessment Through Principal Component Analysis
Badge, Shapali; Hossain, Md Nayeem; Boyce, Heather; Kim, Myong-Jin; Al-Ghabeish, Manar
-
Gastrointestinal Intubation Using a Multi-Port Aspiration Catheter to Study Drug Release of Extended-Release Glipizide Drug Products in The Gastrointestinal Tract of Healthy Humans
Abdelnabi, M; Watts, L; Singh, P; Li, R; Lkhagva, A; Duan, S; Liu, S; Wen, B; Baker, J; Matvekas, A; Chey, WD; Hasler, WL; Raofi, S; Sun, Wei-Jhe; Boyce, Heather; Kinjo, Minori; Pai, MP; Sun, D; Nojkov, B