Pharmaceutical Research

, Volume 24, Issue 9, pp 1603–1607

Commentary on AAPS Workshop

Dissolution Testing for the Twenty-first Century: Linking Critical Quality Attributes and Critical Process Parameters to Clinically Relevant Dissolution
  • Cheng Tong
  • Susan S. D’Souza
  • Jan E. Parker
  • Tahseen Mirza
Commentary

DOI: 10.1007/s11095-007-9280-x

Cite this article as:
Tong, C., D’Souza, S.S., Parker, J.E. et al. Pharm Res (2007) 24: 1603. doi:10.1007/s11095-007-9280-x

Abstract

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.

Key words

AAPS commentary dissolution process analytical technology quality by design workshop 

Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Cheng Tong
    • 1
  • Susan S. D’Souza
    • 2
  • Jan E. Parker
    • 3
  • Tahseen Mirza
    • 4
  1. 1.Pfizer Global Research and DevelopmentPfizer, Inc.GrotonUSA
  2. 2.Oral and Respiratory Product DevelopmentSchering-Plough Research InstituteSummitUSA
  3. 3.Pharmaceutical Analytical DevelopmentLancaster Laboratories, Inc.LancasterUSA
  4. 4.One Health PlazaNovartis Pharmaceutical Corp.East HanoverUSA

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