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Journal of Pharmaceutical Innovation

, Volume 7, Issue 3–4, pp 205–213 | Cite as

The Application of Science- and Risk-Based Concepts to Drug Substance Stability Strategies

  • Stephen T. ColganEmail author
  • Timothy J. Watson
  • Robert D. Whipple
  • Roger Nosal
  • Jon V. Beaman
  • David M. De Antonis
Case Report

Abstract

The International Conference on Harmonization (ICH) has provided practical guidance on the amount and type of drug substance stability data needed to support marketing applications (International Conference on Harmonization 2001, 2002, 2003a, b). Additional guidance has been issued by the World Health Organization (WHO 2009). Recent scientific advances and practices have resulted in improved scientific understanding of the chemical and physical attributes that contribute directly or indirectly to drug substance stability. Combining this improved understanding with the science- and risk-based approaches detailed in ICH Q8, Q9, and Q10 allows for alternative and more scientifically driven approaches to meet the scientific and regulatory objectives for drug substance stability (International Conference on Harmonization 2005, 2008, 2009). In this paper, proposals are presented to more fully leverage enhanced product knowledge to design improved stability strategies. The chemical and physical attributes that potentially impact drug substance stability are discussed, and strategies that leverage accelerated stability studies are presented.

Keywords

Stability Drug substance Stability-related quality attributes Control strategy 

Notes

Acknowledgments

The authors would like to thank Bob Baum, Stephane Caron, Chi-wan Chen, Dave Damon, Allan Edwards, John Groskoph, Chuck Hoiberg, Vince McCurdy, Megan McMahon, Julian Meekings, Greg Sluggett, Robert Timpano, Ken Waterman, Kevin Ryan, Roger Weaver, and PhRMA Stability Expert Team.

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Copyright information

© Springer Science+Business Media New York 2012

Authors and Affiliations

  • Stephen T. Colgan
    • 1
    Email author
  • Timothy J. Watson
    • 1
  • Robert D. Whipple
    • 1
  • Roger Nosal
    • 1
  • Jon V. Beaman
    • 2
  • David M. De Antonis
    • 1
  1. 1.Pfizer Global Research and DevelopmentGrotonUSA
  2. 2.Pfizer Global Research and DevelopmentSandwichUK

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