Document Detail


Assuring quality and performance of sustained and controlled release parenterals: workshop report.
MedLine Citation:
PMID:  12141269     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Diane J Burgess; Ajaz S Hussain; Thomas S Ingallinera; Mei-Ling Chen
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Publication Detail:
Type:  Congresses; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.    
Journal Detail:
Title:  AAPS pharmSci     Volume:  4     ISSN:  1522-1059     ISO Abbreviation:  AAPS PharmSci     Publication Date:  2002  
Date Detail:
Created Date:  2002-07-25     Completed Date:  2002-08-13     Revised Date:  2010-12-21    
Medline Journal Info:
Nlm Unique ID:  100897065     Medline TA:  AAPS PharmSci     Country:  United States    
Other Details:
Languages:  eng     Pagination:  E7     Citation Subset:  IM    
Affiliation:
Department of Pharmaceutics, University of Connecticut, 372 Fairfield Road, Storrs, CT 06269, USA. diane.burgess@uconn.edu
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MeSH Terms
Descriptor/Qualifier:
Biological Availability
Biopolymers / chemistry
Delayed-Action Preparations / classification,  metabolism,  pharmacokinetics,  standards*
Drug Administration Routes
Drug Contamination / prevention & control
Drug Stability
Quality Control
Solvents / chemistry,  standards
Therapeutic Equivalency
Chemical
Reg. No./Substance:
0/Biopolymers; 0/Delayed-Action Preparations; 0/Solvents

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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