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Assuring quality and performance of sustained and controlled release parenterals: EUFEPS workshop report
Diane J Burgess1, Daan J A Crommelin, Ajaz S Hussain
1Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, CT 06269, USA. diane.burgess@uconn.edu
AAPS Pharmsci
|June 17, 2004
Summary
This workshop summarized advances in sustained and controlled release parenteral drug delivery systems. It identified research needs for understanding performance and developing testing procedures for these parenteral formulations.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Regulatory Science
Background:
- A 2003 workshop in Basel, Switzerland, convened experts from industry, regulatory bodies, and academia.
- The meeting focused on assuring the quality and performance of sustained and controlled release parenteral formulations.
- This event served as a follow-up to a 2001 workshop held in Washington, DC.
Framework:
- Discussions centered on the formulation, processing, and manufacturing of parenteral drug delivery systems.
- Key process parameters critical for quality and performance were identified and debated.
- The workshop aimed to bridge knowledge gaps and foster advancements in the field.
Implementation:
- Experts reviewed and discussed current practices in parenteral drug product development.
- The focus was on identifying critical factors influencing the performance of sustained and controlled release systems.
- Advances in the field since the 2001 meeting were highlighted.
Implications:
- The workshop identified specific areas requiring further research to enhance understanding of drug delivery system performance.
- Recommendations were made for developing improved testing procedures for parenteral formulations.
- The outcomes will guide future research, development, and regulatory strategies for these advanced drug delivery systems.