GDUFA Research Outcomes

OA Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to computational modeling of absorption for orally administered drugs to support generic product development and assessment.

• All(163)
• Posters(20)
• Presentations(124)
• Papers(19)

• Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations

  Wang, Yan

• ANDA and Pre-ANDA Experience with OIDP Modeling

  Walenga, Ross

• STATISTICAL EXPERIENCE AND CHALLENGES IN ASSESSING SIMILARITY OF DISSOLUTION PROFILES, PARTICAL SIZE DISTRIBUTIONS AND API SAMENESS

  Tsong, Yi

• Are We Ready to Apply Oral PBPK Modeling for BE Determination?

  Tsang, Yu Chung

• Continuous Skin Sampling Methods for the Assessment of Cutaneous PK-Based Bioequivalence

  Tiffner, Katrin; Boulgaropoulos, Beate; Birngruber, Thomas; Bodenlenz, Manfred; Lackner, Bettina; Raml, Reingard; Sinner, Frank

• Integration of Biopredictive Dissolution and PBPK Models for Evaluation of GI Locally Acting Products: PART I

  Thomas, Sherin

• IVRT Studies During Topical Product Development: Challenges in Method Development and Transfer

  Thakker, Kailas

• Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling

  Tan, Ming-Liang

• IVPT Studies with Topical and Transdermal Products

  Stinchcomb, Audra

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

  Shoyaib, Abdullah