Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments

Candice Johnson; Arianna Bassan; Doug Kiehl; Diane Paskiet; Manuela Pavan; Patricia Parris; Geraldine Whelan; Anders Burild; Glenn J. Myatt

doi:10.5731/pdajpst.2022.012819

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Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments

Candice Johnson, Arianna Bassan, Doug Kiehl, Diane Paskiet, Manuela Pavan, Patricia Parris, Geraldine Whelan, Anders Burild and Glenn J. Myatt

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 237-311; DOI: https://doi.org/10.5731/pdajpst.2022.012819

Candice Johnson

1Instem, 1393 Dublin Road, Columbus, OH;

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For correspondence: candice.johnson@instem.com

Arianna Bassan

2Innovatune, Via Giulio Zanon 130/D, 35129 Padova, Italy;

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Doug Kiehl

3Eli Lilly and Company, Indianapolis, IN 46285;

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Diane Paskiet

4West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341;

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Manuela Pavan

2Innovatune, Via Giulio Zanon 130/D, 35129 Padova, Italy;

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Patricia Parris

5Pfizer Worldwide Research, Development and Medical, Sandwich, United Kingdom;

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Geraldine Whelan

6GlaxoSmithKline, Ware, United Kingdom; and

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Anders Burild

7Novo Nordisk A/S, Safety Sciences and Imaging, Måløv, Denmark;

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Glenn J. Myatt

1Instem, 1393 Dublin Road, Columbus, OH;

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vol. 78 no. 3 237-311

DOI

https://doi.org/10.5731/pdajpst.2022.012819

PubMed

38942479

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 28, 2024.

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previous version (December 19, 2023 - 03:26).
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Author Information

Candice Johnson^1,*,
Arianna Bassan²,
Doug Kiehl³,
Diane Paskiet⁴,
Manuela Pavan²,
Patricia Parris⁵,
Geraldine Whelan⁶,
Anders Burild⁷ and
Glenn J. Myatt¹

¹Instem, 1393 Dublin Road, Columbus, OH;
²Innovatune, Via Giulio Zanon 130/D, 35129 Padova, Italy;
³Eli Lilly and Company, Indianapolis, IN 46285;
⁴West Pharmaceutical Services, Inc., 530 Herman O. West Drive, Exton, PA 19341;
⁵Pfizer Worldwide Research, Development and Medical, Sandwich, United Kingdom;
⁶GlaxoSmithKline, Ware, United Kingdom; and
⁷Novo Nordisk A/S, Safety Sciences and Imaging, Måløv, Denmark;

↵* Corresponding author: Instem, 1393 Dublin Road, Columbus, OH; E-mail candice.johnson{at}instem.com

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Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments

Candice Johnson, Arianna Bassan, Doug Kiehl, Diane Paskiet, Manuela Pavan, Patricia Parris, Geraldine Whelan, Anders Burild, Glenn J. Myatt

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 237-311; DOI: 10.5731/pdajpst.2022.012819

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Characterizing Extractables and Leachables Chemical Space to Support In Silico Toxicological Hazard Assessments

Candice Johnson, Arianna Bassan, Doug Kiehl, Diane Paskiet, Manuela Pavan, Patricia Parris, Geraldine Whelan, Anders Burild, Glenn J. Myatt

PDA Journal of Pharmaceutical Science and Technology May 2024, 78 (3) 237-311; DOI: 10.5731/pdajpst.2022.012819

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Keywords

Dermal sensitization
Mutagenicity
Extractables and leachables
Computational assessments
Chemical class analysis

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