Application of multiplexed pharmacokinetic immunoassay to quantify in vivo drug forms and coadministered biologics
Aim: Meso Scale Discovery U-PLEX® provides an opportunity to develop multiplexed pharmacokinetic (PK) immunoassays. Two case studies demonstrate the utility of multiplexed PK methods. Materials & methods: Development of PK ligand-binding assays quantify of nonclinical plasma concentrations of a biotherapeutic that has degraded due to in vivo biotransformation, and clinical serum concentrations from two biotherapeutics spiked into a single sample. Results: Data from multiplexed U-PLEX PK methods are comparable to results from single-readout streptavidin Meso Scale Discovery gold PK methods. Multiplex measurement of a nonclinical study showed acceptable performance for accuracy, precision and dilutional linearity while a clinical study additionally passed selectivity, specificity and stability. Conclusion: Regulated, validation-ready multiplex PK methods for both nonclinical and clinical studies allow opportunities for high-throughput bioanalysis.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2019 |
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| Erschienen: |
2019 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:11 |
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| Enthalten in: |
Bioanalysis - 11(2019), 24 vom: 25. Dez., Seite 2251-2268 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Woodbury, Nicole [VerfasserIn] |
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| Links: |
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| Themen: |
Bioanalysis |
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| Anmerkungen: |
Date Completed 21.04.2020 Date Revised 21.04.2020 published: Print Citation Status MEDLINE |
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| doi: |
10.4155/bio-2019-0147 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM304465224 |
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Aim: Meso Scale Discovery U-PLEX® provides an opportunity to develop multiplexed pharmacokinetic (PK) immunoassays. Two case studies demonstrate the utility of multiplexed PK methods. Materials & methods: Development of PK ligand-binding assays quantify of nonclinical plasma concentrations of a biotherapeutic that has degraded due to in vivo biotransformation, and clinical serum concentrations from two biotherapeutics spiked into a single sample. Results: Data from multiplexed U-PLEX PK methods are comparable to results from single-readout streptavidin Meso Scale Discovery gold PK methods. Multiplex measurement of a nonclinical study showed acceptable performance for accuracy, precision and dilutional linearity while a clinical study additionally passed selectivity, specificity and stability. Conclusion: Regulated, validation-ready multiplex PK methods for both nonclinical and clinical studies allow opportunities for high-throughput bioanalysis | ||
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