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)

• Application of Physiologically Based Absorption Modeling for Amphetamine Salts Drug Products in Generic Drug Evaluation

  Zhang, Xinyuan

• Snapshots of Iron Speciation: Tracking the Fate of Iron Nanoparticle Drugs via a Liquid Chromatography-Inductively Coupled Plasma- Mass Spectrometric Approach

  Neu, Heather; Alexishin, Sergei; Brandis, Joel; Williams, Anne; Li, Wenjing; Sun, Dajun; Zheng, Nan; Jiang, Wenlei; Zimrin, Ann; Fink, Jeffrey; Polli, James; Kane, Maureen; Michel, Sarah

• Interactions of Oral Molecular Excipients with Breast Cancer Resistance Protein, BCRP

  Zou, Ling; Pottel, Joshua; Khuri, Natalia; Ngo, Huy; Ni, Zhanglin; Tsakalozou, Eleftheria; Warren, Mark; Huang, Yong; Schoichet, Brian; Giacomini, Kathleen

• The Effect of Excipients on the Permeability of BCS Class III Compounds and Implications for Biowaivers

  Alan, Parr; Hidalgo, Ismael; Bode, Chris; Brown, William; Yazdanian, Mehran; Gonzalez, Mario; Sagawa, Kazuko; Miller, Kevin; Jiang, Wenlei; Stippler, Erika

• Investigating the Impact of Drug Crystallinity in Amorphous Tacrolimus Capsules on Pharmacokinetics and Bioequivalence Using Discriminatory in Vitro Dissolution Testing and PBPK Modeling and Simulation

  Purohit, Hitesh; Trasi, Niraj; Sun, Dajun; Chow, Edwin; Wen, Hong; Zhang, Xinyuan; Gao, Yi; Taylor, Lynne

• Modeling and Mechanistic Approaches for Oral Absorption: Quality by Design in Action

  Yu, Lawrence; Zhang, Xinyuan; Lionberger, Robert

• Scientific considerations to move towards biowaiver for biopharmaceutical classification system class III drugs: How modeling and simulation can help

  Wu, Fang; Cristofoletti, Rodrigo; Zhao, Liang; Rostami-Hodjegan, Amin

• Reply to “On the Effect of Common Excipients on the Oral Absorption of Class 3 Drugs”

  Vaithianathan, Soundarya; Haidar, Sam; Zhang, Xinyuan; Jiang, Wenlei; Avon, Christopher; Dowling, Thomas; Shao, Changxing; Kane, Maureen; Hoag, Stephen; Flasar, Mark; Ting, Tricia; Polli, James

• Gastric Emptying and Intestinal Appearance of Nonabsorbable Drugs Phenol Red and Paromomycin in Human Subjects: A Multi-Compartment Stomach Approach

  Paixao, Paulo; Bermejo, Marival; Hens, Bart; Tsume, Yasuhiro; Dickens, Joseph; Shedden, Kerby; Salehi, Niloufar; Koenigsknecht, Mark; Baker, Jason; Hasler, William; Lionberger, Robert; Fan, Jianghong; Wysocki, Jeffrey; Wen, Bo; Lee, Allen; Frances, Ann; Amidon, G E; Yu, A; Benninghoff, G; Lobenberg, R; Talattof, A; Sun, D; Amidon, G L

• Transporters in Regulatory Science: Notable Contributions from Dr. Giacomini in the Past Two Decades

  Zhang, Lei; Liu, Qi; Huang, Shiew Mei; Lionberger, Robert