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)

• Development of PBPK Model for Predicting Food Impact on BE Assessment

  Shoyaib, Abdullah

• Consideration Factors on Study Population Selection for Bioequivalence Studies with Pharmacokinetic Endpoints

  Shon, Jihong

• Amphotericin B Liposome: Revisions of the Product Specific Guidance

  Qin, Bin

• Evaluation of Dissolution Profile Similarity for Bioequivalence Assessment

  Mousa, Youssef

• Modeling for Success: A Case Example for Oseltamivir Phosphate

  Mousa, Youssef

• Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness

  Kozak, Darby

• Data-driven & Science-based Recommendation on Harmonization of Bioequivalence Standards for Narrow Therapeutic Index Drugs

  Jiang, Wenlei

• Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices

  Jiang, Wenlei

• In Vivo Relevance of Dissolution

  Jiang, Wenlei

• Summary of 2nd GBHI Worshop Session IV: Exclusion of Pharmacokinetic Data is Bioequivalence Assessment

  Jiang, Wenlei