GDUFA Research Outcomes
BE Methods and Analyses
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to bioequivalence methods and analyses for generic drug products.
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Challenges and Opportunities when Using Oral PBPK to Support Risk Assessment and Biowaiver in Regulatory Submissions
Wu, Fang
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Regulatory and Scientific Considerations on Characterizations of Complex Polymeric Excipients
Wang, Yan
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Bioequivalence Approaches for Long-Acting Drug Products: Regulatory and Scientific Considerations
Wang, Yan
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Exploiting Dual Solid State PBPK Tools to Assess the Bio(in)equivalence of Tacrolimus Amorphous Formulations with Various Degrees of Crystallization Arising During Storage
Turner, David
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PBPK Modeling of Supersaturating Drug Products
Turner, David
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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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Alternative BE Approaches for Data Analysis Due To COVID-19 Related Study Interruptions
Gong, Yuqing
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A Dynamic Bile Salt Model to Predict Bile Salt Disposition within the GI Luminal Fluids
Stamatopoulos, Konstantinos
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In Silico Tools to Simulate the Regional Differences of the Human GI Tract
Stamatopoulos, Konstantinos
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Navigating Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness
Kozak, Darby