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Novum’s Pina D’Angelo, Speaker and Panelist at 2015 ASA Biopharmaceutical Section FDA - Industry Statistics Workshop
Sep 1, 2015
Pittsburgh, PA: Pina D’Angelo has been selected as a featured presenter and discussion panelist for the 2015 ASA Biopharmaceutical Session FDA Industry Workshop, to be held on September 16th – 18th. The conference will include sessions co-chaired by statisticians from industry, academia, and FDA.
On September 18th at 8:30 AM, Ms. D’Angelo will be one of five panelists discussing the topic of “Messy Data Issues in Evaluation of Bioequivalence”. This session will include two presentations on this subject and a panel that will present and discuss issues and statistical approaches in the area of bioequivalence.
At 12:45 PM, the same day, Ms. D’Angelo will be giving a presentation on the topic of “Statistical Analyses and Issues in Skin Adhesion and Irritation and Sensitization Studies”. This session will provide an overview of the regulatory requirements for generic submissions of transdermal/topical patch systems with focus on the design of and statistical analyses for adhesion, irritation and sensitization (I/S) studies.