Assuring quality and performance of sustained and controlled release parenterals: workshop report.
This is a summary report of the American Association of Pharmaceutical Scientists, the Food and Drug Administration and the United States Pharmacopoeia co-sponsored 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 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, meetings and working groups in this area.
Burgess
Diane J
DJ
Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, CT 06269, USA. diane.burgess@uconn.edu
Hussain
Ajaz S
AS
Ingallinera
Thomas S
TS
Chen
Mei-Ling
ML
D001682:Biological Availability; D001704:Biopolymers / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000145:classification / Q000378:metabolism / Q000493:pharmacokinetics / Q000592:standards*; D004333:Drug Administration Routes; D004340:Drug Contamination / Q000517:prevention & control; D004355:Drug Stability; D011786:Quality Control; D012997:Solvents / Q000737:chemistry / Q000592:standards; D013810:Therapeutic Equivalency
D001704:Biopolymers; D003692:Delayed-Action Preparations; D012997:Solvents