Design and Modeling Considerations for Skin Permeation Studies

• Activity Number: 305
• Type: Contributed
• Date/Time: Tuesday, August 5, 2014 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Areti Manola*+ and Juan Chen and Jyh-Ming Shoung and Stan Altan
• Companies: Janssen and Janssen and Janssen and Janssen
• Keywords: Skin Permeation ; Mixed Effects Modeling ; Nested Design

Abstract

Transdermal Drug Delivery Systems (TDDS), also referred to as patch products, are becoming a more common drug delivery form since their convenience and dosing properties make them an attractive alternative to oral and other forms of drug delivery. In vitro skin permeation or skin diffusion analytical methods are commonly used to assess product quality, changes on stability, formulation and manufacturing effects. We present a novel application of a randomized nested block design that permits an unambiguous decomposition of the total variability into its component parts of skin donor, pieces nested within skin and residual error. With such a design, changes in the skin permeation profile on stability for a drug product lot are appropriately estimated and tested. We provide a case study to illustrate the design and associated statistical modeling.