Assuring quality and performance of sustained and controlled release parenterals: AAPS workshop report, co-sponsored by FDA and USP.
This is a summary report of the American Association of Pharmaceutical Scientists, the Food and Drug Administration, and the United States Pharmacopoeia cosponsored workshop on "Assuring Quality and Performance of Sustained and Controlled Release Parenterals." Experts from the pharmaceutical industry, the 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. Areas were identified where research is needed 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, meetings, and working groups in this area.
Burgess
Diane J
DJ
Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, Connecticut 06269, USA. dburgess@uconnvm.uconn.edu
Hussain
Ajaz S
AS
Ingallinera
Thomas S
TS
Chen
Mei-Ling
ML
D003692:Delayed-Action Preparations / Q000592:standards*; D004345:Drug Industry / Q000592:standards*; D006801:Humans; D007263:Infusions, Parenteral / Q000592:standards; D010602:Pharmacopoeias as Topic / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
D003692:Delayed-Action Preparations