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OtherResearch

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 September 2023, pdajpst.2022.012811; DOI: https://doi.org/10.5731/pdajpst.2022.012811
Patricia Parris
1 Pfizer Worldwide Research, Development and Medical, Sandwich, UK;
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  • For correspondence: patricia.parris@pfizer.com
Geraldine Whelan
2 GlaxoSmithKline, Ware, UK;
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  • For correspondence: geraldine.b.whelan@gsk.com
Anders Burild
3 Novo Nordisk A/S, Safety Sciences and Imaging, Malov, Denmark;
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  • For correspondence: qabu@novonordisk.com
Jessica Whritenour
4 Pfizer Worldwide Research, Development and Medical, Groton, CT, USA;
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  • For correspondence: jessica.duffy-whritenour@pfizer.com
Uma Bruen
5 Organon USA Inc., Jersey City, NJ, USA;
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  • For correspondence: uma.bruen@organon.com
Joel Bercu
6 Gilead Sciences Inc., Foster City, CA, USA;
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  • For correspondence: joel.bercu@gilead.com
Courtney Callis
7 Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN, USA;
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  • For correspondence: courtney.callis@lilly.com
Martyn L. Chilton
8 Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK;
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  • For correspondence: martyn.chilton@lhasalimited.org
Jessica Graham
9 Genentech, Inc., South San Francisco, CA, USA;
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  • For correspondence: graham.jessica@gene.com
Esther Johann
10 Merck KGaA, Darmstadt, Germany;
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  • For correspondence: esther.johann@merckgroup.com
Candice Johnson
11 Instem, 1393 Dublin Road, Columbus, Ohio USA;
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  • For correspondence: cjohnson@leadscope.com
Troy Griffin
12 Teva Branded Pharmaceutical Products R&D, West Chester, PA, USA;
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  • For correspondence: troy.griffin@tevapharm.com
Martin Kohan
13 formerly of Global Sustainability, AstraZeneca, Cambridge, UK;
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  • For correspondence: martin.kohan@safebridge.com
Elizabeth A. Martin
14 Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK;
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  • For correspondence: elizabeth.martin@astrazeneca.com
Melisa Masuda-Herrera
15 Gilead Sciences;
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Brad Stanard
16 Ultragenyx Pharmaceutical Inc., Novato, CA, USA;
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  • For correspondence: bstanard@ultragenyx.com
Maureen T Cruz
17 Faegre Drinker Biddle & Reath LLP;
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  • For correspondence: maureen.cruz@faegredrinker.com
Lee Nagao
18 Faegre Drinker Biddle & Reath
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Article Information

pdajpst.2022.012811
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 
  • Received December 7, 2022
  • Accepted August 17, 2023
  • Published online September 15, 2023.

Article Versions

  • You are currently viewing a previous version of this article (September 15, 2023 - 07:31).
  • View the most recent version of this article
Copyright & Usage 
Copyright © 2023, Parenteral Drug Association

Author Information

  1. Patricia Parris1,19 (patricia.parris{at}pfizer.com),
  2. Geraldine Whelan2 (geraldine.b.whelan{at}gsk.com),
  3. Anders Burild3 (qabu{at}novonordisk.com),
  4. Jessica Whritenour4 (jessica.duffy-whritenour{at}pfizer.com),
  5. Uma Bruen5 (uma.bruen{at}organon.com),
  6. Joel Bercu6 (joel.bercu{at}gilead.com),
  7. Courtney Callis7 (courtney.callis{at}lilly.com),
  8. Martyn L. Chilton8 (martyn.chilton{at}lhasalimited.org),
  9. Jessica Graham9 (graham.jessica{at}gene.com),
  10. Esther Johann10 (esther.johann{at}merckgroup.com),
  11. Candice Johnson11 (cjohnson{at}leadscope.com),
  12. Troy Griffin12 (troy.griffin{at}tevapharm.com),
  13. Martin Kohan13 (martin.kohan{at}safebridge.com),
  14. Elizabeth A. Martin14 (elizabeth.martin{at}astrazeneca.com),
  15. Melisa Masuda-Herrera15 (melisa.masuda-herrera{at}gilead.com),
  16. Brad Stanard16 (bstanard{at}ultragenyx.com),
  17. Maureen T Cruz17 (maureen.cruz{at}faegredrinker.com) and
  18. Lee Nagao18 (lee.nagao{at}faegredrinker.com)
  1. 1 Pfizer Worldwide Research, Development and Medical, Sandwich, UK;
  2. 2 GlaxoSmithKline, Ware, UK;
  3. 3 Novo Nordisk A/S, Safety Sciences and Imaging, Malov, Denmark;
  4. 4 Pfizer Worldwide Research, Development and Medical, Groton, CT, USA;
  5. 5 Organon USA Inc., Jersey City, NJ, USA;
  6. 6 Gilead Sciences Inc., Foster City, CA, USA;
  7. 7 Lilly Research Laboratories, Eli Lilly & Company, Indianapolis, IN, USA;
  8. 8 Lhasa Limited, Granary Wharf House, 2 Canal Wharf, Leeds, LS11 5PS, UK;
  9. 9 Genentech, Inc., South San Francisco, CA, USA;
  10. 10 Merck KGaA, Darmstadt, Germany;
  11. 11 Instem, 1393 Dublin Road, Columbus, Ohio USA;
  12. 12 Teva Branded Pharmaceutical Products R&D, West Chester, PA, USA;
  13. 13 formerly of Global Sustainability, AstraZeneca, Cambridge, UK;
  14. 14 Clinical Pharmacology and Safety Sciences, R&D, AstraZeneca, Cambridge, UK;
  15. 15 Gilead Sciences;
  16. 16 Ultragenyx Pharmaceutical Inc., Novato, CA, USA;
  17. 17 Faegre Drinker Biddle & Reath LLP;
  18. 18 Faegre Drinker Biddle & Reath
  1. ↵* Corresponding author; email: patricia.parris{at}pfizer.com

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PDA Journal of Pharmaceutical Science and Technology: 79 (2)
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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 Sep 2023, pdajpst.2022.012811; DOI: 10.5731/pdajpst.2022.012811

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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 Sep 2023, pdajpst.2022.012811; DOI: 10.5731/pdajpst.2022.012811
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Keywords

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

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