Reflecting Novum’s industry leadership in transdermal clinical research, senior Scientific Affairs members Martin Kozicki, Pina D’Angelo, Niraj Shethji, and CSO Keith Gallicano presented A Comparison of Statistical Methods for Assessing Adhesion with Transdermal Delivery Systems at the AAPS Annual Meeting in San Diego, CA. The poster compared the adhesion results from the historical NI approach with those from the new statistical NI approach, delineated in the FDA draft guidance issued June 2016.
In June 2016, the FDA released a draft guidance titled “Assessing Adhesion with Transdermal Delivery Systems and Topical Patches for ANDAs”, which supersedes “recommendations related to adhesion studies provided in individual product-specific guidances” published before the date of publication of this guidance. The purpose of this presentation was to recommend an effective and efficient adhesion method by comparing 20 studies conducted at Novum in which various transdermal systems/patches were applied to healthy volunteers as per the duration recommended within the prescribing information of each respective product.
Business Development Manager Mark Crain also was onsite.
To arrange a meeting with our Scientific Team and/or Business Development, please contact Mark Crain at (412) 432-9342 or by email at firstname.lastname@example.org.
- Poster Title: A Comparison of Statistical Methods for Assessing Adhesion with Transdermal Delivery Systems
- Poster number: M5042
- Session Date: November 13, 2017
- Session Time: 01:00 pm – 02:00 pm
- Forum Number: 3