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)

• 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

• Stability 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

• 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

• 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

• Evaluation of Glucose Administration Recommendation in Bioequivalence Studies to Support Generic Oral Antidiabetic Drug Development

  Xi, Xinyuan

• In Vitro Evaluation of an Extended-Release Methylphenidate Hydrochloride Product Sprinkled on Food Vehicles

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

• A Brief Review of FDA-Approved New Drug Applications Labeled with Sprinkle Administration

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