Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform
Abstract 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 characteristi...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
2023-02-01
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| Series: | CPT: Pharmacometrics & Systems Pharmacology |
| Online Access: | https://doi.org/10.1002/psp4.12887 |
| _version_ | 1797905437160374272 |
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| author | Linnea C. Franssen Maciej J. Swat Andrzej M. Kierzek Rachel H. Rose Piet H. van derGraaf Hans Peter Grimm |
| author_facet | Linnea C. Franssen Maciej J. Swat Andrzej M. Kierzek Rachel H. Rose Piet H. van derGraaf Hans Peter Grimm |
| author_sort | Linnea C. Franssen |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-04-10T10:05:16Z |
| format | Article |
| id | doaj.art-0b455ac83df04d72a28167efc170f4e1 |
| institution | Directory Open Access Journal |
| issn | 2163-8306 |
| language | English |
| last_indexed | 2024-04-10T10:05:16Z |
| publishDate | 2023-02-01 |
| publisher | Wiley |
| record_format | Article |
| series | CPT: Pharmacometrics & Systems Pharmacology |
| spelling | doaj.art-0b455ac83df04d72a28167efc170f4e12023-02-15T21:42:18ZengWileyCPT: Pharmacometrics & Systems Pharmacology2163-83062023-02-0112213914310.1002/psp4.12887Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platformLinnea C. Franssen0Maciej J. Swat1Andrzej M. Kierzek2Rachel H. Rose3Piet H. van derGraaf4Hans Peter Grimm5Roche Pharma Research and Early Development Pharmaceutical Sciences, Roche Innovation Center Basel Basel SwitzerlandCertara Sheffield UKCertara Sheffield UKCertara Sheffield UKCertara Sheffield UKRoche Pharma Research and Early Development Pharmaceutical Sciences, Roche Innovation Center Basel Basel SwitzerlandAbstract 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.https://doi.org/10.1002/psp4.12887 |
| spellingShingle | Linnea C. Franssen Maciej J. Swat Andrzej M. Kierzek Rachel H. Rose Piet H. van derGraaf Hans Peter Grimm Learn–confirm in model‐informed drug development: Assessing an immunogenicity quantitative systems pharmacology platform CPT: Pharmacometrics & Systems Pharmacology |
| 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 |
| url | https://doi.org/10.1002/psp4.12887 |
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