| Biography | |
|---|---|
 Prof. Yong Guo Fairleigh Dickinson University, USA |
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| Title: Setting the specification limits on in-vitro release rates for a new transdermal product | |
| Abstract: Transdermal drug delivery systems (i.e., transdermal patches) have been increasingly used in various therapeutic areas, such as pain management, hormonal therapy, neurological disorders, and smoking cessation. A new transdermal patch has been developed using the drug-in-adhesive design with permeation enhancers for pain management. Although the in-vitro performance of the transdermal patches is typically evaluated based on skin flux in Franz cell, release rate testing (i.e., dissolution testing) is required for quality control purposes. An in-vitro release rate method has been developed using USP Apparatus VII, and the release and stability data have been collected in a registration stability study over a 2-year period. For marketing approval (i.e., NDA approval), specification limits for the in-vitro release rate need to be established and approved by the regulatory authorities (i.e., FDA). An initial proposal of the specification limits for the release rate was developed based on the available release and stability data and was included in the NDA filing. During the NDA review process, FDA challenged the proposed specification limits and made a counter proposal. Based on the regulatory guidance and detailed data analysis, a new set of specification was proposed and eventually accepted by FDA. The presentation will focus on the experiences in establishing a reasonable specification and revising the specification to meet the expectation of the regulatory agency. | |
| Biography: Dr. Guo is currently Professor of Pharmaceutical Science and Director for Research and Graduate Programs at School of Pharmacy and Health Sciences, Fairleigh Dickinson University (FDU). Dr. Guo holds a Ph.D degree in chemistry from the State University of New York at Buffalo as well as a MBA degree in Pharmaceutical Management from Fairleigh Dickinson University. Dr. Guo joined the FDU School of Pharmacy and Health Sciences in 2012 following a 15-year career in pharmaceutical industry. At FDU, he teaches professional Doctor of Pharmacy students in the area of pharmaceutical sciences, including physical pharmacy, pharmaceutical calculation, pharmaceutical biotechnology, and pharmacokinetics. In addition, Dr. Guo also serves as Director for Research and Graduate Programs overseeing the Master of Health Sciences program. Prior to his academic career, Dr. Guo was an Associate Director at Janssen Pharmaceutical Research and Development, a pharmaceutical company of Johnson & Johnson. He was primarily responsible for leading and managing project teams in support of new drug development and registration. Dr. Guo has been involvedin numerous drug development projects both at the early and late stages, including method development and validation, stability studies, technology transfer and regulatory filing; and he has made significant contributions to two successful NDA filings and one MAA filing. | |
