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October 1 - 2, 2009
AAPS Workshop on Challenges and
Opportunities in Establishing Scientific and Regulatory Standards for Assuring Therapeutic Equivalence
of Modified Release Products
Sheraton Inner Harbor Hotel, Baltimore, MD
An historical problem encountered by formulation scientists has always been the
lack of harmonized standards for excipients. Each of the national pharmacopeias
contains monographs for specifications and test methods for only a portion of the
existing excipients. However, many of these standards are not unified amongst the
various pharmacopeias. In 1991, the International Pharmaceutical Excipients Council
(IPC) was formed in order to develop harmonized pharmacopeia excipient standards,
harmonized GMP guidelines, and harmonized new excipient safety evaluation guidelines.
The development of simple, affordable, reproducible, universally applicable, meaningful,
and realistic functionality tests for the “fingerprinting” of pharmaceutical ingredients
(excipients) is highly desired by both the excipient and pharmaceutical manufacturers.
However, at present, the excipients are only tested for quality, uniformity, identity,
safety and purity. Performance standards have never been required. In 1991, the
USP/NF formed a special advisory panel in order to develop internationally applicable
physical testing methods for basic powders (such as density, compactability, etc.).
None of these tests has been made a part of USP yet. The main mission of the Excipients
Focus Group is to communicate and collaborate with IPC, USP, and Excipient Manufacturers
in order to speed up the realization/completion of the harmonized activities and
standard functionality test methods.
The Ralph Shangraw Memorial Award
The Ralph Shangraw Memorial Award is awarded to any person who has provided an outstanding
research in the study of excipients or excipient-related technology. The award recognizes
research achievements broadly in the field of pharmaceutical excipients including
but not limited to research that contributes to an understanding of the basic science
underlying excipients functionally; excipient safety, including the development
of test methods and standards; the development of new excipients or novel use of
existing in new applications; and the development of rational compendial/regulatory
standards for excipients. The award recipients will receive $10,000.
IPEC Foundation Graduate Student Awards
The IPEC Foundation is sponsoring five annual awards to acknowledge excellence in
research conducted at graduate level pertaining to the field of excipients. The
awards focus on recent significant contributions to formulation science and technology
with excipients brought about by highly innovative research. All interested candidates
engaged in their final year of graduate studies leading to Ph.D. degree (or to be
awarded in the year of submission) are encouraged to apply. The awardees will receive
a cash award of $1,000 and a commemorative plaque. If selected, the applicant must
attend the 2009 AAPS Annual Meeting & Exposition.
To apply, please visit http://www.ipecfoundation.org/.
Important Links
Meeting Minutes
Upcoming Conference Calls
The Excipients Focus Group steering committee conducts business during monthly conference
calls held on the fourth Friday of each month. If you are interested in joining
the calls, please contact
Otilia Koo, Chair of the Excipients Focus Group.
All calls are held at 10:00-11:00 am Eastern Time. Note that other countries do
not change summer/wintertime on the same date as the United States.
- January 30
- February 27
- March 27
- April 24
- May 29
June 21-24: 2009 National Biotechnology Conference
- June 26
- July 31
- August 28
- September 25
- October 30
No call in November; the group meets at the annual meeting: 2009 Annual Meeting,
November 8-12
No call in December due to the holidays
JOIN THE EXCIPIENTS FOCUS GROUP
To join the Excipients Focus Group, click
here.
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