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.
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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
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Evaluation of Glucose Administration Recommendation in Bioequivalence Studies to Support Generic Oral Antidiabetic Drug Development
Xi, Xinyuan
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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
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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
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Brand-to-Generic Therapeutic Equivalence Analysis of Modified-Release (MR) Oral Drug Products
Wen, Hong; Zhang, Xinyuan; Fang, Lanyan; Dutcher, Sarah; Babiskin, Andrew; Zhao, Liang; Jiang, Wenlei; Lionberger, Robert; Sun, Dajun
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Exploring Factors Affecting Nifedipine Biphasic Dissolution Profile Using an inForm Platform
Tian, Li; Box, Karl; Swoboda, Moriah; Tang, Fuxing; Lin, Ho-Pi; Jiang, Wenlei; Ruzicka, Connie; Rodriguez, Jason; Gao, Zongming
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Dissolution Testing of Nifedipine ER Tablet Using the USP Flow-Through Method
Tian, Li; Ye, Wei; Rodriguez, Jason; Sun, Dajun; Jiang, Wenlei; Lin, Ho-Pi; Gao, Zongming
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Dissolution Rate Increases for Morphine Sulfate Extended-Release Drug Product when Mixed with High pH Soft Food for Long Contact Times
Rana, Md Sohel; Jordan, Lorne; Wu, Kai-Wei; Feng, Xin; Sun, Wei-Jhe; Xia, Li; Hwang, Sung Yong; Nwakama, Patrick E; Kim, Myong Jin; Tampal, Nilufer; Boyce, Heather; Tian, Li
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Dissolution Testing of Diltiazem HCI Extended-Release Capsule Products
Li, Min; Gao, Zongming; Tang, Fuxing; Choi, Stephanie; Toth, Roxana; Rodriguez, Jason
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Assessment of the Impact of Drug Dissolution on Pharmacokinetics of Diltiazem Extended Release Drug Products Using Physiologically Based Pharmacokinetic Analysis
Li, Min; Gao, Zongming; Tang, Fuxing; Choi, Stephanie; Toth, Roxana; Rodriguez, Jason