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(127)
• Posters(7)
• Presentations(111)
• Papers(9)

• 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

• 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

• The In Vitro Release Test (IVRT): Historical Perspective, Current Context, and Future Directions

  Shah, Vinod

• USP <1724> and <1002> Prospective Scope and Content

  Santos, Leandro

• IVPT Studies During Topical Product Development

  Santos, Leandro

• Effect of Formulation Differences on Critical Quality Attributes and Performance of the Complex Topical Products

  Sachdeva, Sameer