1. Commentary on AAPS Workshop.
- Author
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Cheng Tong, Susan DâSouza, Jan Parker, and Tahseen Mirza
- Subjects
HISPANIC American scientists ,PHYSICAL measurements ,PHARMACEUTICAL industry ,PHARMACEUTICAL services - Abstract
Abstract  This is a summary report of the workshop entitled âDissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution,â 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. [ABSTRACT FROM AUTHOR]
- Published
- 2007
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