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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 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

Article Information

vol. 78 no. 4 399-444
DOI 
https://doi.org/10.5731/pdajpst.2022.012811
PubMed 
37714567
Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online August 23, 2024.

Article Versions

Copyright & Usage 
© PDA, Inc. 2024

Author Information

  1. Patricia Parris1,*,
  2. Geraldine Whelan2,
  3. Anders Burild3,
  4. Jessica Whritenour4,
  5. Uma Bruen5,
  6. Joel Bercu6,
  7. Courtney Callis7,
  8. Martyn L. Chilton8,
  9. Jessica Graham9,
  10. Esther Johann10,
  11. Candice Johnson11,
  12. Troy Griffin12,
  13. Martin Kohan13,
  14. Elizabeth A. Martin14,
  15. Melisa Masuda-Herrera6,
  16. Brad Stanard15,
  17. Maureen T. Cruz1,7 and
  18. Lee Nagao16
  1. 1Pfizer Worldwide Research, Development and Medical, Sandwich, United Kingdom;
  2. 2GlaxoSmithKline, Ware, United Kingdom;
  3. 3Novo Nordisk A/S, Safety Sciences and Imaging, Måløv, Denmark;
  4. 4Pfizer Worldwide Research, Development and Medical, Groton, CT;
  5. 5Organon USA Inc., Jersey City, NJ;
  6. 6Gilead Sciences Inc., Foster City, CA;
  7. 7Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN;
  8. 8Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, United Kingdom;
  9. 9Genentech, Inc., South San Francisco, CA;
  10. 10Merck KGaA, Darmstadt, Germany;
  11. 11Instem, 1393 Dublin Road, Columbus, OH ;
  12. 12Teva Branded Pharmaceutical Products R&D, West Chester, PA;
  13. 13formerly of Global Sustainability, AstraZeneca, Cambridge, United Kingdom;
  14. 14Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, United Kingdom; and
  15. 15Ultragenyx Pharmaceutical Inc., Novato, CA
  16. 16Faegre Drinker Biddle & Reath LLP, Washington, DC
  1. ↵* Corresponding Author: Drug Safety Research & Development, Portfolio, Regulatory Strategy, Pfizer Worldwide Research, Sandwich, Kent, United Kingdom CT13 9NJ; Telephone: +44 7880414083; E-mail: Patricia.parris{at}pfizer.com
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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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