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

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 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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For correspondence: melisa.masuda-herrera@gilead.com

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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For correspondence: lee.nagao@faegredrinker.com

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PDA Journal of Pharmaceutical Science and Technology

Vol. 79, Issue 1

January/February 2025

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

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

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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Parenteral Drug Association, Inc.