Commentary on AAPS Workshop: dissolution testing for the twenty-first century: linking critical quality attributes and critical process parameters to clinically relevant dissolution

This is a summary report of the workshop entitled "Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution," organized by the In Vitro Release and Dissolution Testing Focus Group of the America...

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Bibliographic Details
Published in:Pharmaceutical research 2007-09, Vol.24 (9), p.1603-1607
Main Authors: Tong, Cheng, D'Souza, Susan S, Parker, Jan E, Mirza, Tahseen
Format: Article
Language:English
Subjects:
Chemistry, Pharmaceutical
Dissolution
Dosage Forms
Pharmaceutical industry
Pharmacology
Solubility
Technology, Pharmaceutical
Workshops
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Summary:This is a summary report of the workshop entitled "Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution," organized by the In Vitro Release and Dissolution Testing Focus Group of the American Association of Pharmaceutical Scientists. Participants from the pharmaceutical industry, regulatory authorities, and academia in the US, Europe, and Japan attended this workshop to review, discuss, and explore the role of traditional dissolution testing in the new arena of Quality by Design (QbD) and Process Analytical Technology (PAT). Other areas of discussion were the use of the dissolution test to evaluate drug release from novel dosage forms, challenges in dissolution testing and specification setting, and dissolution apparatus calibration using performance verification tablets versus mechanical calibration. The workshop identified areas where further research and collaboration are needed to advance knowledge and understanding of the science of dissolution. Views expressed in this report are those of the authors and do not necessarily reflect those of the FDA and USP.
ISSN:0724-8741
1573-904X
DOI:10.1007/s11095-007-9280-x