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

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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.

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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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Authors and Affiliations

  1. Pfizer Global Research and Development, Groton, CT, USA

    Stephen T. Colgan, Timothy J. Watson, Robert D. Whipple, Roger Nosal & David M. De Antonis

  2. Pfizer Global Research and Development, Sandwich, UK

    Jon V. Beaman

Authors
  1. Stephen T. Colgan
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  2. Timothy J. Watson
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  3. Robert D. Whipple
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  4. Roger Nosal
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  5. Jon V. Beaman
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  6. David M. De Antonis
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Corresponding author

Correspondence to Stephen T. Colgan.

Additional information

Some of these concepts were presented at the AAPS Current Trends in Stability Workshop (Washington, D.C., September 2009): Colgan S. “The Application of Quality by Design’s Science and Risk Based Concepts to API Stability Strategies”

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Colgan, S.T., Watson, T.J., Whipple, R.D. et al. The Application of Science- and Risk-Based Concepts to Drug Substance Stability Strategies. J Pharm Innov 7, 205–213 (2012). https://doi.org/10.1007/s12247-012-9135-9

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  • DOI: https://doi.org/10.1007/s12247-012-9135-9

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