PMCCPMCCPMCC

Search tips
Search criteria 

Advanced

 
Logo of pharmscispringer.comThis journalToc AlertsSubmit OnlineOpen Choice
 
AAPS PharmSci. Mar 2004; 6(1): 100–111.
Published online Mar 22, 2004. doi:  10.1208/ps060111
PMCID: PMC2750946
Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report
Diane J. Burgess,corresponding author1 Daan J. A. Crommelin,2 Ajaz S. Hussain,3 and Mei-Ling Chen3
1Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, 06269 Storrs, CT USA
2Faculty of Pharmaceutical Sciences, Utrecht University, Sorbonnelaan 16, 3584 CA Utrecht, The Netherlands
3Office of Pharmaceutical Science, Center for Drug Evaluation and Research, Food and Drug Administration, 5515 Security Lane, HFD-3, 20852 Rockville, MD USA
Diane J. Burgess, Phone: 860-486-3760, Fax: 860-486-4998, diane.burgess/at/uconn.edu.
corresponding authorCorresponding author.
Received February 6, 2004; Accepted February 6, 2004.
This is a summary report of the workshop, organized by the European Federation of Pharmaceutical Scientists in association with the American Association of Pharmaceutical Scientists, the European Agency for the Evaluation of Medicinal Products, the European Pharmacopoeia, the US Food and Drug Administration and the United States Pharmacopoeia, on “Assuring Quality and Performance of Sustained and Controlled Release Parenterals” held in Basel, Switzerland, February 2003. Experts from the pharmaceutical industry, regulatory authorities and academia participated in this workshop to review, discuss and debate formulation, processing and manufacture of sustained and controlled release parenterals, and identify critical process parameters and their control. This workshop was a follow-up workshop to a previous workshop on Assuring Quality and Performance of Sustained and Controlled Release Parenterals that was held in Washington, DC in April 2001. This report reflects the outcome of the Basel 2003 meeting and the advances in the field since the Washington, DC meeting in 2001. As necessary, the reader is referred to the report on the 2001 meeting. Areas were identified at the 2003 Basel meeting where research is needed in order to understand the performance of these drug delivery systems and to assist in the development of appropriate testing procedures. Recommendations were made for future workshops and meetings.
Footnotes
This report may contain statements of opinion that are those of the author(s) and do not necessarily reflect the opinions of EUFEPS or its members, AAPS or its members, the European Agency for the Evaluation of Medicinal Products, the European Pharmacopoeia the Food and Drug Administration or the United States Pharmacopoeia.
Planning committee
Speakers and discussion leaders
References
1. Burgess DJ, Hussain AS, Ingallinera TS, Chen M. Assuring quality and performance of sustained and controlled release parenterals. AAPS Pharm Sci 2002; 4(2): article 7 Available at: http://www.aapspharmsci.org/view.asp?art-ps040207. [PMC free article] [PubMed]
Articles from AAPS PharmSci are provided here courtesy of
American Association of Pharmaceutical Scientists