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Novum Team Members to Present at 2013 AAPS Annual Meeting and Exposition in San Antonio, TX
Sep 20, 2013
Pittsburgh, PA: Dr. Keith Gallicano, Vice President, Scientific Affairs and Ms. Pina D’Angelo, Senior Director, Scientific Affairs (Biostatistics), have been invited to speak at an AAPS Mini-Symposium: “Strategies and Issues in the Design and Data Analysis of Skin Adhesion, Irritation and Sensitization Studies for Bioequivalence Evaluation of Transdermal/Topical Patch Generic Drug Products,” to be held in conjunction with the 2013 AAPS Annual Meeting and Exposition, November 10-14, San Antonio, TX.
Dr. Gallicano’s presentation will provide an overview of the different types of transdermal/topical drug delivery systems, and the design and conduct of skin adhesion, irritation and sensitization studies to meet regulatory requirements for generic submissions of these drug products. Issues associated with the categorical rating scales for adhesion and irritation data will be discussed.
Ms. D’Angelo’s presentation will focus on the statistical approaches recommended by FDA for evaluation of non-inferiority in adhesion and irritation studies. Various statistical procedures for this type of data analysis, along with some real-life and simulated examples, and the issues associated with these procedures, will be presented.