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)

• Characterizing a Design Space for a Twin-Screw Wet Granulation Process: a Case Study of Extended-Release Tablets

  Sierra Vega, Nobel; Alsharif, Fahd M; O’connor, Thomas; Ashraf, Muhammad; Zidan, Ahmed

• The Effect of Food Vehicles on In Vitro Performance of Pantoprazole Sodium Delayed Release Sprinkle Formulation

  Wu, Kai-Wei; Zheng, Kai; Tian, Li; Xia, Li; Hwang, Sung Yong; Nwakama, Patrick E; Sun, Wei Jhe; Kim, Myong Jin; Tampal, N; Xu, Xiaoming; Boyce, Heather; Feng, Xin

• Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products

  Raw, Andre; Lionberger, Robert; Yu, Lawrence

• In Vitro Approaches to Support Bioequivalence and Substitutability of Generic Proton Pump Inhibitors via Nasogastric Tube Administration

  Ren, Ping; Cui, Minglei; Anand, Om; Xia, Li; Zhao, Zhuojun; Sun, Dajun; Sharp, Trueman; Conner, Dale; Peters, John; Jiang, Wenlei; Stier, Ethan; Jiang, Xiaojian

• Comparison of Generic-to-Brand Switchback Patterns for Generic and Authorized Generic Drugs

  Hansen, Richard; Qian, Jingjing; Berg, Richard; Linneman, James; Seoane Vazquez, Enrique; Dutcher, Sarah; Raofi, Saeid; Page, David; Peissig, Peggy

• The Biopharmaceutics Classification System: Subclasses for In Vivo Predictive Dissolution (IPD) Methodology and IVIVC

  Tsume, Yasuhiro; Mudie, Deanna; Langguth, Peter; Amidon, Greg; Amidon, Gordon

• Ghost-Pill-Buster: A Case Study of Intact Levetiracetam Extended-Release Tablets after Dissolution Testing

  Sun, Dajun; Wen, Hong; Externbrink, Anna; Gao, Zongming; Keire, David; Krauss, Gregory; Jiang, Wenlei

• Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges

  Wen, Hong; Jung, Huijeong; Li, Xuhong

• Analysis of Bead Sizes for MR Capsules Labeled for Sprinkle

  Nagavelli, Laxma; Lionberger, Robert; Sayeed, Vilayat; Yu, Lawrence; Allgire, James; Smith, Anjanette; Wokovich, Anna; Westenberger, Benjamin; Buhse, Lucinda

• Effects of Dissolution Medium pH and Simulated Gastrointestinal Contraction on Drug Release from Nifedipine Extended-Release Tablets

  Gao, Zongming; Ngo, Cindy; Ye, Wei; Rodriguez, Jason; Keire, David; Sun, Dajun; Wen, Hong; Jiang, Wenlei