GDUFA Research Outcomes

BE Methods & 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(237)
• Posters(60)
• Presentations(64)
• Papers(113)

• Survey of Bioequivalence Data of Abbreviated New Drug Applications of Narrow Therapeutic Index Drug Products

  Anno, Krista; Mina, Mirette; Zhang, Zhen; Zhang, Lei; Jiang, Wenlei

• Exploration for Exclusion of Females of Reproductive Potential as a Bioequivalence Study Population in Product-Specific Guidances for Generic Drug Development

  Paleracio, Christian Grace; Nguyen, Duyen; Li, Karen; Tsui, Cynthia; Frost, Mitchell; Kim, Myong – Jin; Shon, Jihong

• Swallowability of Solid Oral Drug Products in Regulatory Submissions: Patient-Specific Features, Product Physical Attributes, and Clinical Swallowability Study Designs

  Mcguire, Meredith; Mostofa, Agm; Shon, Jihong; Frost, Mitchell; Kim, Myong Jin; Li, Karen

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

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

• Bacterial Metabolism Rescues the Inhibition of Intestinal Drug Absorption by Food and Drug Addictives

  Zou, Ling; Spanogiannopoulos, Peter; Chien, Huan-Chieh; Pieper, Lindsey; Cai, Wenlong; Khuri, Natalia; Pottel, Joshua; Vora, Bianca; Ni, Zhanglin; Tsakalozou, Eleftheria; Zhang, Wenjun; Shoichet, Brian; Turnbaugh, Peter; Giacomini, Kathleen

• Interactions of Azo Dyes Commonly used in Oral Drug Products with the Organic Anion Transporting Peptide 2B1 and Human Gut Bacteria

  Zou, Ling; Spanogiannopoulos, Peter; Ni, Zhanglin; Tsakalozou, Eleftheria; Zhang, Lei; Turnbaugh, Peter; Giacomini, Kathleen

• Excipients Inhibit Human Organic Anion Transporting Peptide 2B1 (OATP2B1)-Mediated Intestinal Uptake of Levothyroxine

  Zou, Ling; Zhang, Xinyuan; Ni, Zhanglin; Tsakalozou, Eleftheria; Giacomini, Kathleen

• Modeling Dynamic Gastrointestinal Fluid Transit As A Basis For Dissolution And Absorption

  Yu, Alex; Jackson, Trachette; Amidon, Gordon; Marciani, Luca; Sun, Duxin

• Impact of Excipients on BCS Class 3 Oral Drug Absorption.

  Vaithianathan, Soundarya; Zhang, Xinyuan; Jiang, Wenlei; Polli, James

• The Incorporation of Absorptive Phase into the In Vivo Predictive Dissolution (Ipd) System to Predict Better In Vivo Dissolution for Ketoconazole and Raloxifene

  Tsume, Yasuhiro; Igawa, Naoto; Drelich, Adam; Amidon, Gordon