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...

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Autores principales: Franssen, Linnea C., Swat, Maciej J., Kierzek, Andrzej M., Rose, Rachel H., van der Graaf, Piet H., Grimm, Hans Peter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
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.
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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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