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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The journey from Developing the Research Studies to Drafting a New Regulatory Standard: A Case Study with Acyclovir Cream
Raney, Sam
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GDUFA Research and Regulatory Initiatives for Complex Topical Products
Raney, Sam
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Cutaneous Pharmacokinetics and pharmacodynamics for the 21st Century
Raney, Sam
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Equivalence of Locally-Acting Drug Products
Raney, Sam
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In Vitro Characterization of Topical Semisolid Dosage Forms
Raney, Sam
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Facilitating Patient Access to High Quality Generics: A Case Study in Regulatory Science
Raney, Sam
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Why Do We Call Excipients in Topical Products Inactive Ingredients?
Raney, Sam
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Dosage Form And Function: Bioavailability And Bioequivalence Implications For Topical Dermatological Products
Raney, Sam
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The Matter Of Medicine-Does Form Follow Function Or Vice Versa?
Raney, Sam
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Considerations Relating To Product Quality Characterization For Topical Semisolid Dosage Forms
Raney, Sam