GDUFA Research Outcomes

BE Methods and Analyses

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.

• All(192)
• Posters(44)
• Presentations(45)
• Papers(103)

• The Evaluation of In Vitro Drug Dissolution of Commercially Available Oral Dosage Forms for Itraconazole in Gastrointestinal Simulator with Biorelevant Media

  Matsui, Kazuki; Tsume, Yasuhiro; Amidon, Gregory; Amidon, Gordon

• In Vivo Dissolution and Systemic Absorption of Immediate Release Ibuprofen in Human Gastrointestinal Tract under Fed and Fasted Conditions

  Koenigsknecht, Mark; Baker, Jason; Wen, Bo; Frances, Ann; Zhang, Huixia; Yu, Alex; Zhao, Ting; Tsume, Yasuhiro; Pai, Manjunath; Bleske, Barry; Zhang, Xinyuan; Lionberger, Robert; Lee, Allen; Amidon, Gordon; Hasler, William; Sun, Duxin

• Physiologically Based Pharmacokinetic Modeling for Substitutability Analysis of Venlafaxine Hydrochloride Extended-Release Formulations Using Different Release Mechanisms: Osmotic Pump Versus Openable Matrix

  Lin, Hopi; Sun, Dajun; Zhang, Xinyuan; Wen, Hong

• Non-Sink Dissolution Conditions for Predicting Product Quality and In Vivo Performance of Supersaturating Drug Delivery Systems

  Sun, Dajun; Wen, Hong; Taylor, Lynne

• A Bioequivalence Approach for Generic Narrow Therapeutic Index Drugs: Evaluation of the Reference-Scaled Approach and Variability Comparison Criterion

  Jiang, Wenlei; Makhlouf, Fairouz; Schuirmann, Donald; Zhang, Xinyuan; Zheng, Nan; Conner, Dale; Yu, Lawrence; Lionberger, Robert

• A Protocol for Assay of Poly(lactide-co-glycolide) in Clinical Products

  Garner, John; Skidmore, Sarah; Park, Haesun; Park, Kinam; Choi, Stephanie; Wang, Yan

• Measuring the Impact of Gastrointestinal Variables on the Systemic Outcome

  Hens, Bart; Talattof, Arjang; Paixao, Paulo; Bermejo, Marival; Tsume, Yasuhiro; Lobenberg, Raimar; Amidon, Gordon

• Pulse Packet Stochastic Model for Gastric Emptying in the Fasted State: A Physiological Approach

  Amidon, Gordon

• Assessing the Impact of Endogenously Derived Crystalline Drug on the In Vivo Performance of Amorphous Formulations

  Purohit, Hitesh; Trasi, Niraj; Osterling, Donald; Stolarik, Deanne; Jenkins, Gary; Gao, Wenqing; Zhang, Geoff; Taylor, Lynne

• Utility of Physiologically Based Pharmacokinetic Absorption Modeling to Predict the Impact of Salt-to-Base Conversion on Prasugrel HCl Product Bioequivalence in the Presence of Proton Pump Inhibitors

  Fan, Jianghong; Zhang, Xinyuan; Zhao, Liang