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Research ArticleResearch

Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis

Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz and Lee Nagao
PDA Journal of Pharmaceutical Science and Technology July 2024, 78 (4) 399-444; DOI: https://doi.org/10.5731/pdajpst.2022.012811
Patricia Parris
1Pfizer Worldwide Research, Development and Medical, Sandwich, United Kingdom;
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  • For correspondence: Patricia.parris@pfizer.com
Geraldine Whelan
2GlaxoSmithKline, Ware, United Kingdom;
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Anders Burild
3Novo Nordisk A/S, Safety Sciences and Imaging, Måløv, Denmark;
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Jessica Whritenour
4Pfizer Worldwide Research, Development and Medical, Groton, CT;
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Uma Bruen
5Organon USA Inc., Jersey City, NJ;
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Joel Bercu
6Gilead Sciences Inc., Foster City, CA;
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Courtney Callis
7Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN;
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Martyn L. Chilton
8Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, United Kingdom;
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Jessica Graham
9Genentech, Inc., South San Francisco, CA;
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Esther Johann
10Merck KGaA, Darmstadt, Germany;
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Candice Johnson
11Instem, 1393 Dublin Road, Columbus, OH ;
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Troy Griffin
12Teva Branded Pharmaceutical Products R&D, West Chester, PA;
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Martin Kohan
13formerly of Global Sustainability, AstraZeneca, Cambridge, United Kingdom;
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Elizabeth A. Martin
14Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, United Kingdom; and
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Melisa Masuda-Herrera
6Gilead Sciences Inc., Foster City, CA;
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Brad Stanard
15Ultragenyx Pharmaceutical Inc., Novato, CA
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Maureen T. Cruz
1Pfizer Worldwide Research, Development and Medical, Sandwich, United Kingdom;
7Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN;
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Lee Nagao
16Faegre Drinker Biddle & Reath LLP, Washington, DC
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  • Article
  • Figures & Data
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PDA Journal of Pharmaceutical Science and Technology: 78 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 78, Issue 4
July/August 2024
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Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz, Lee Nagao
PDA Journal of Pharmaceutical Science and Technology Jul 2024, 78 (4) 399-444; DOI: 10.5731/pdajpst.2022.012811
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  • Article
    • Abstract
    • Introduction
    • Methods
    • Results
    • Discussion
    • Future Work
    • Conclusion
    • Acknowledgements
    • Appendix 1. Information Sources for Literature Search and ELSIE Safety Database
    • Appendix 2. Raw Data and In Silico Assessment of Sensitizers with and without an EC3 Potency Value
    • Appendix 3. Local Effects Monographs of 15 Chemicals Predicted Strong or Extreme Skin Sensitizers
    • A4. Additional Monographs for 1 Extreme Skin Sensitizer and 1 Predicted Strong Skin Sensitizer Added Following Creation of the Potency Dataset
    • References
  • Figures & Data
  • References
  • Info & Metrics
  • PDF

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Keywords

  • Extractables
  • Leachables
  • Sensitization
  • Potency
  • In silico
  • Risk Assessment
  • Threshold

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Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database Analysis
Patricia Parris, Geraldine Whelan, Anders Burild, Jessica Whritenour, Uma Bruen, Joel Bercu, Courtney Callis, Martyn L. Chilton, Jessica Graham, Esther Johann, Candice Johnson, Troy Griffin, Martin Kohan, Elizabeth A. Martin, Melisa Masuda-Herrera, Brad Stanard, Maureen T. Cruz, Lee Nagao
PDA Journal of Pharmaceutical Science and Technology Jul 2024, 78 (4) 399-444; DOI: 10.5731/pdajpst.2022.012811

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