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.

• All(66)
• Posters(31)
• Presentations(24)
• Papers(11)

• 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

• Improving Administration Method Consistency of Product-Specific Guidances for Chewable Tablets and Tablet Products with Chewing in Labeling

  Lim, Hye Lim; Boyce, Heather; Kim, M; Sun, W

• 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; Kim, Myong Jin

• In Vitro Evaluation of Morphine Sulfate Extended – Release Formulation Sprinkled on Soft Foods – A Comparison of Two Dosage Strengths of T=0 M and T=6 M Drug Products

  Rana, Md Sohel; Wu, Kai Wei; Feng, Xu; Sun, Wei Jhe; Xia, Li; Nwakama, Patrick; Kim, Myong Jin; Tampal, Nilufer; Abdallah, Ihab; Boyce, Heather; Tian, Li

• ��In Vitro Evaluation of Excipients as Inhibitors of Human Intestinal P-glycoprotein

  Bajaj, R; Chong, L; Zhou, L; Tsakalozou, E; Ni, Z; Giacomini, K; Kroetz D

• In Vitro Performance of Pantoprazole Sodium Delayed Release Granules when Sprinkled on Soft Foods

  Zheng, Kai; Jordan, Lorne; Tian, Li; Hoover, Alicia; Mahjabeen, Sanjida; Sun, Wei Jhe; Xia, Li; Lee, Sue Chih; Hwang, Sung Yong; Nwakama, Patrick; Xi, Xinyuan; Kim, Myong Jin; Tampal, Nilufer; Boyce, Heather; Feng, Xin