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.
-
Topical Semisolid Drug Product Critical Quality Attributes (Q3 Characterization) with Relevance to Topical Bioequivalence
Murthy, Narasimha
-
Characterizing Failure Modes And Critical Quality (Q3) Attributes Of Semi-Solid Topical Drug Products
Murthy, Narasimha
-
Evaluating Quality (Q3) Attributes And Potential Failure Modes For Topical Semisolid Drug Products
Murthy, Narasimha
-
“No Difference” Standard vs. Q1/Q2 Sameness for Topical Drug Products
Kelchen, Megan
-
An FDA Perspective on the Comparative Analyses of Critical Material, Quality, and Design Attributes for Topical, Transdermal, Rectal, and Vaginal Drug-Device Combination Products
Kelchen, Megan
-
Locally Acting Drug Update
Luke,Markham
-
Advancing the Science of How Topically Applied Drugs Penetrate the Skin and Clinical Relevance – The Viewpoint of an FDA Dermatologist
Luke, Markham C
-
FDA and the Dermatologist – The Basics about FDA and a New Paradigm for Generic Topical Drug Bioequivalence
Luke, Markham C
-
Equivalence of Locally-Acting Drug Products
Luke, Markham
-
On Understanding the Clinical Relevance of “Formulation” for Topical Applied to the Skin
Luke, Markham