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)

• 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

• The Development of In Vivo Predictive Dissolution (Ipd) System, Mini-Gastrointestinal Simulator (Mgis), for Bcs Class Iib Drug. The Case Study of Anticancer Drug; Dasatinib.

  Amidon, Gordon

• Solubility and Dissolution of Binary Co-Amorphous Ritonavir-Lopinavir Solid Dispersions

  Taylor, Lynne

• Dissolution Behavior and Solubility of Marketed Amorphous Solid Dispersions of Tacrolimus

  Taylor, Lynne

• Stability of Marketed Tacrolimus Amorphous Dispersions Against Crystallization

  Taylor, Lynne

• A Stochastic Fluid Packet Emptying and Transit Model: A Physiological Approach to Gastrointestinal Transit of Fluid

  Amidon, G L