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.
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ANDA and Pre-ANDA Experience with OIDP Modeling
Walenga, Ross
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STATISTICAL EXPERIENCE AND CHALLENGES IN ASSESSING SIMILARITY OF DISSOLUTION PROFILES, PARTICAL SIZE DISTRIBUTIONS AND API SAMENESS
Tsong, Yi
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Are We Ready to Apply Oral PBPK Modeling for BE Determination?
Tsang, Yu Chung
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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
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IVRT Studies During Topical Product Development: Challenges in Method Development and Transfer
Thakker, Kailas
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Reverse Translational Assessment of CYP450- and OATP-Mediated Clearance in Chronic Kidney Disease: from Clinical Data to PBPK Modeling
Tan, Ming-Liang
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IVPT Studies with Topical and Transdermal Products
Stinchcomb, Audra
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The In Vitro Release Test (IVRT): Historical Perspective, Current Context, and Future Directions
Shah, Vinod
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USP <1724> and <1002> Prospective Scope and Content
Santos, Leandro
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IVPT Studies During Topical Product Development
Santos, Leandro