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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Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products
Raw, Andre; Lionberger, Robert; Yu, Lawrence
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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
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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
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The Biopharmaceutics Classification System: Subclasses for In Vivo Predictive Dissolution (IPD) Methodology and IVIVC
Tsume, Yasuhiro; Mudie, Deanna; Langguth, Peter; Amidon, Greg; Amidon, Gordon
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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
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Drug Delivery Approaches in Addressing Clinical Pharmacology-Related Issues: Opportunities and Challenges
Wen, Hong; Jung, Huijeong; Li, Xuhong
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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
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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
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Nifedipine Release From Extended-Release Solid Oral Formulations Using In Vitro Dissolution Testing Under Simulated Gastrointestinal Compression
Gao, Zongming; Tian, Li; Rodriguez, Jason