-
Pharmaceutical Nanoparticulate Drug Delivery Systems
Tuesday, November 13
8:30 am – 11:00 am
Symposium
ACPE #073-999-07-559-L04
Nanotechnology has been identified as an emerging platform to deliver poorly soluble drugs via various routes of administration to enhance bioavailability, allow tissue targeting, improve therapeutic efficacy, to name a few. Because of its nano size and enormous surface area, there is an increasing safety concern for the drug products. It is important to understand the compounding and processing variables that affect the nano-product quality. The Quality-by- Design (QbD) approach coupled with novel process analytical technologies are likely to help address the product quality and safety issues. Currently there is a black box of information available on which regulatory guidelines can be built. This symposium will present the most pertinent and practical issues in the manufacturing, characterizing, and biological applications of nanoparticles as it relates to the QbD paradigm.
Moderators
Indra K. Reddy, Ph.D.
Texas A & M Health Sciences Center
Rakhi B. Shah, Ph.D.
U.S. Food and Drug Administration
Unique Material and Physicochemical Properties of Nanoparticulate Drug Delivery Systems
Melgardt D. Villiers, Ph.D.
University of Wisconsin
Engineering Novel Nanoconstructs for Targeted Delivery of Bioactive Agents
Hamid Ghandehari, Ph.D.
University of Maryland
Nanoparticles for Drug and Gene Delivery
Uday B. Kompella, Ph.D.
University of Nebraska
Novel Technologies and Quality by Design Considerations for Nanoparticles
Mansoor A. Khan, Ph.D.
U.S. Food and Drug Administration