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(50)
• Posters(23)
• Presentations(18)
• Papers(9)

• Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment

  Jiang, Wenlei

• Equivalence Criteria for In Vitro BE Tests for Locally Acting Drug Products: The Earth Mover’s Distance Approach

  Hu, Meng

• Development of PBPK Model for Predicting Food Impact on BE Assessment

  Shoyaib, Abdullah

• Generic Oral Modified Release Drug Products: Establishing Bioequivalence for Additional Strengths

  Sun, Wei Jhe; Wang, Rong

• Potential Impact of Gastric pH on Generic Drug Bioequivalence Evaluation

  Fan, Jianghong

• PBPK Absorption Modeling to Support Risk Assessment and Biowaiver for Generic Oral Products

  Wu, Fang

• Establishing Bioequivalence for “Additional Strengths” of Oral Modified-Release Drug Products

  Boyce, Heather

• 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