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(251)
• Posters(64)
• Presentations(67)
• Papers(120)

• A Survey on Recommendation of Food Conditions in Bioequivalence Studies with Pharmacokinetic Endpoints for Generic Oral Antineoplastic Drug Development

  Kim, Myong-Jin; Li, Karen; Shon, Jihong

• FDA Perspective on Dissolution Testing for Development of High-Risk Oral Drug Products Containing Amorphous Solid Dispersions

  Zhao, Gang; Wei, Kevin; Nguyen, Duyen; Lim, Hye-Lim; Rege, Bhagwant; Lu, Dongmei; Zhang, Qi

• Safety Considerations of Subject Population Selection in Bioequivalence Studies for Generic Drug Development

  Tran, Tony; Bae, Jungeun; Nguyen, Duyen; Shon, Jihong; Kim, Myong-Jin; Borges, Silvana; Li, Karen

• A Generic Tacrolimus Capsule Shown Not to Be Bioequivalent to the Brand Tacrolimus Capsule in a Post-approval Pharmacokinetic Bioequivalence Study in Healthy Subjects

  Sun, Wei-Jhe; Mahjabeen, Sanjida; Kinjo, Minori; Thomas, Sherin; Wu, Fang; Ni, Zhanglin; Frost, Mitchell; Markollari, Artan; Best, Ryan; Le, Sunny; Kim, Myong-Jin; Zhao, Liang

• 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

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

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