Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform
Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics, efficacy, and safety. Predicting immunogenicity is complex because of its multifactorial drivers, including compound properties, subject characteristics, and t...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9931426/ https://www.ncbi.nlm.nih.gov/pubmed/36418887 http://dx.doi.org/10.1002/psp4.12887 |
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author | Franssen, Linnea C. Swat, Maciej J. Kierzek, Andrzej M. Rose, Rachel H. van der Graaf, Piet H. Grimm, Hans Peter |
author_facet | Franssen, Linnea C. Swat, Maciej J. Kierzek, Andrzej M. Rose, Rachel H. van der Graaf, Piet H. Grimm, Hans Peter |
author_sort | Franssen, Linnea C. |
collection | PubMed |
description | Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics, efficacy, and safety. Predicting immunogenicity is complex because of its multifactorial drivers, including compound properties, subject characteristics, and treatment parameters. To integrate these, the Immunogenicity Simulator was developed using published, predominantly late‐stage trial data from 15 therapeutic proteins. This single‐blinded evaluation with subject‐level data from 10 further monoclonals assesses the Immunogenicity Simulator's credibility for application during the drug development process. |
format | Online Article Text |
id | pubmed-9931426 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-99314262023-02-16 Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform Franssen, Linnea C. Swat, Maciej J. Kierzek, Andrzej M. Rose, Rachel H. van der Graaf, Piet H. Grimm, Hans Peter CPT Pharmacometrics Syst Pharmacol Perspectives Immunogenicity against therapeutic proteins frequently causes attrition owing to its potential impact on pharmacokinetics, pharmacodynamics, efficacy, and safety. Predicting immunogenicity is complex because of its multifactorial drivers, including compound properties, subject characteristics, and treatment parameters. To integrate these, the Immunogenicity Simulator was developed using published, predominantly late‐stage trial data from 15 therapeutic proteins. This single‐blinded evaluation with subject‐level data from 10 further monoclonals assesses the Immunogenicity Simulator's credibility for application during the drug development process. John Wiley and Sons Inc. 2022-11-23 /pmc/articles/PMC9931426/ /pubmed/36418887 http://dx.doi.org/10.1002/psp4.12887 Text en © 2022 F. Hoffmann‐La Roche AG and Certara. CPT: Pharmacometrics & Systems Pharmacology published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Perspectives Franssen, Linnea C. Swat, Maciej J. Kierzek, Andrzej M. Rose, Rachel H. van der Graaf, Piet H. Grimm, Hans Peter Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform |
title | Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform |
title_full | Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform |
title_fullStr | Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform |
title_full_unstemmed | Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform |
title_short | Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform |
title_sort | learn–confirm in model‐informed drug development: assessing an immunogenicity quantitative systems pharmacology platform |
topic | Perspectives |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9931426/ https://www.ncbi.nlm.nih.gov/pubmed/36418887 http://dx.doi.org/10.1002/psp4.12887 |
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