GDUFA Research Outcomes
Topical Products
This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to locally acting generic products administered via the topical route, including topical dermatological products.
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Bioequivalence Evaluation of Narrow Therapeutic Index Drugs – Rationales for the Current Regulatory Approach by U.S. FDA
Jiang, Wenlei
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U.S. FDA Recommendation on Bioequivalence Demonstration of Topical Drug Products
Jiang, Wenlei
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Therapeutic Equivalence of Compositionally Different Topical Products: Correlation of Product Characteristics with Sensorial Attributes
Ramezanli, Tannaz
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Practical Considerations for IVRT Studies with Topical Drug Products Submitted in ANDAs
Ramezanli, Tannaz
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Development of Efficient Alternative Bioequivalence Approaches for Topical Dermatological Drug Products
Ramezanli, Tannaz
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Generic Versions of Narrow Therapeutic Index Drugs National Survey of Pharmacists’ Substitution Beliefs and Practices
Jiang, Wenlei
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Theoretical Principles and Best Practices In Vitro Release Testing (IVRT)
Ramezanli, Tannaz
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SRS Microscopy and Deep Learning: Novel Approach for Evaluation of Topical Bioequivalence
Iliopoulos, Fotis
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Topical Dermatological Drug Products Complex Generic Drug Products (CGDPs) with a locally-acting route of delivery
Ramezanli, Tannaz; Simamora, Pahala; Babiskin, Andrew; Luke, Markham
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Use of Q3 Characterization Tests for Topical Semisolid Drug Products
Raney, Sam