AAPS Announces Workshop on Assuring Quality, Performance of
Sustained and Controlled Release Parenterals
ARLINGTON, Va. - The American Association of Pharmaceutical Scientists
(AAPS) will present the AAPS Workshop on Assuring Quality and Performance of
Sustained and Controlled Release Parenterals on April 19-20, 2001, at the Hyatt
Regency Washington on Capitol Hill in Washington, DC. Parenteral describes a
method of drug delivery in which the drug enters the body by some means other
than the intestine, usually injected in liquid form.
“This groundbreaking event provides a forum to bring together the leaders
in industry, government and academia, to discuss the pertinent issues in assuring
the quality and performance of sustained and controlled release parenterals,”
said workshop co-chair and AAPS President-Elect, Diane Burgess, Ph.D. “This
workshop will lay the groundwork for the development of guidelines for regulatory
activity in this emerging area. With the biotech and genomic revolutions occurring,
these delivery systems are becoming more important.”
This workshop, co-sponsored with FDA and United States Pharmacopeia, will cover
dispersed systems (microspheres, liposomes, gels and suspensions) as well as
implants of small molecule and protein/peptide therapeutics for human and animal
use. Participants in this workshop will engage in discussions and breakout sessions
that will identify future directions for regulatory activity and public standards
in this rapidly emerging area.
Workshop participants will:
- Define and review specifications/characterization for delivery device manufacture;
- Identify and discuss critical process parameters and their control;
- Discuss accelerated stability and emerging in vitro release testing methods
for these products; and,
- Assess bioavailability, bioequivalence and pharmaceutical equivalence and
explore the opportunity for in vitro-in vivo correlation of these products.
Participants will also have an opportunity to meet with suppliers, including
Daiichi Jitsuoyo (America) Inc., Hanson Research Corporation, and Southern
BioSystems, Inc.
About AAPS
AAPS is a professional, scientific society of more than 11,000 members employed
in academia, industry, government and other research institutes worldwide. Founded
in 1986, AAPS aims to advance science through the open exchange of scientific
knowledge, serve as an information resource, and contribute to human health
through pharmaceutical research and development. For more information about
AAPS, visit AAPS Pharmaceutica at www.aapspharmaceutica.com.
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