“Assuring Quality and Performance of Sustained and Controlled Release Parenterals”, Co-sponsored by FDA and USP, 4/19-20, 2001.
Intended to identify gaps in our understanding of sustained and controlled release parenterals, including liposome drug products.
Discussed critical formulation and process variables for developing necessary specification/characterization that assure product quality and performance.
Discussed bioavailability, bioequivalence and pharmaceutical equivalence.
No conclusion was reached regarding the appropriate approaches to assess pharmaceutical equivalence and bioavailability/bioequivalence.