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Science and Risked-Based Stability Testing Strategies—a Test Case on the Global Implementation and Regulatory Reception

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Abstract

The global regulatory implementation and acceptance of a science and risk-based stability (SRB) strategies for a stable drug product is reviewed. This stability strategy may also be referred to as “lean stability” since it includes a stability protocol reduction in the number of tests and time points than might normally be applied. A product line extension (new solid dosage form) for a well-understood product was used as a test case for this stability strategy. The drug product line extension was filed globally with a proposed reduction to analytical stability tests and frequency. This stability protocol is aligned with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) Q1A (R2) stability guidelines (ICH: Guideline Q1A(R2), 2003), the World Health Organization (WHO) (WHO INT. [Online], 2020), and most country regulatory guidelines. Although this strategy was not accepted universally, the strategy enabled opportunities to engage in productive dialogs with regulatory authorities in several countries on how the case leveraged product understanding and development knowledge to develop a fit for purpose stability protocol. A persistent and consistent effort from industry to move toward product-specific protocols based on product knowledge and stability risk assessments should lead to further acceptance of science and risk-based stability strategies in all regions.

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Acknowledgments

The authors would like to thank the reviewers, including John Groskoph, Robert Timpano, Timothy Watson, Connie Langer, Chi-wan Chen, Flavia Firmino, Alfonsus Karli, Mike Saleh, and Supriya Bagwe, for reviewing and providing helpful comments on this paper.

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Authors and Affiliations

  1. Global Product Development- Global Regulatory Affairs- Global Manufacturing and Controls, Pfizer Inc., Eastern Point Road, Groton, Connecticut, 06340, USA

    Dorys Argelia Diaz, Megan McMahon & Stephen T. Colgan

  2. Global Regulatory Affairs CMC, Alexion Pharmaceuticals Inc., Boston, Massachusetts, USA

    Michael Lynch

  3. Global Regulatory Affairs Oncology Healthcare Business of Merck, Darmstadt, Hessen, Germany

    Raquel Oblessuc

  4. North Stonington, USA

    Stephen T. Colgan

Authors
  1. Dorys Argelia Diaz
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  2. Michael Lynch
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  3. Megan McMahon
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  5. Stephen T. Colgan
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Correspondence to Dorys Argelia Diaz.

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Diaz, D.A., Lynch, M., McMahon, M. et al. Science and Risked-Based Stability Testing Strategies—a Test Case on the Global Implementation and Regulatory Reception. AAPS J 22, 140 (2020). https://doi.org/10.1208/s12248-020-00515-3

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