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)

• 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

• Nifedipine Release From Extended-Release Solid Oral Formulations Using In Vitro Dissolution Testing Under Simulated Gastrointestinal Compression

  Gao, Zongming; Tian, Li; Rodriguez, Jason

• Quantitative Methods and Modeling to Evaluate Alternative Approaches for COVID-19 Interrupted Bioequivalence Studies

  Zhao, Liang