Assuring quality and performance of sustained and controlled release parenterals (original) (raw)

2004, European Journal of Pharmaceutical Sciences

AI-generated Abstract

The report discusses the outcomes of a workshop focused on the quality and performance assurance of sustained and controlled release parenterals, which convened in February 2003 in Basel, Switzerland. Sponsored by multiple regulatory and pharmaceutical organizations, the workshop aimed to review formulation, processing, and control of these drug delivery systems while identifying critical parameters and emerging testing methods. The report highlights the discussions on formulation, stability, bioequivalence, and future regulatory directions, also referencing an earlier workshop in the USA that laid the groundwork for the current discussions.