Elucidation of the statistical factors that influence anti-drug antibody cut point setting through a multi-laboratory study / Kazuko Nishimura, Hiroko Shibata, Muneo Aoyama, Jun Hosogi, Kenta Kadotsuji, Kyoko Minoura, Tamiki Mori, Takahiro Nakamura, Kazuhiro Nishimiya, Tatsuki Nomura, Tetsu Saito, Masako Soma, Hiroki Wakabayashi, Norihisa Sakamoto, Shingo Niimi, Noriko Katori, Yoshiro Saito, Akiko Ishii-Watabe
Aim:Appropriateness of anti-drug antibody (ADA) assay is critical for immunogenicity assessment of biopharmaceuticals. Although cut point setting in ADA assay has a large impact on the results, a standard statistical approach for its setting has not been well established.Methodology:In this multi-laboratory study, to elucidate factors influencing the cut point setting, we compared the statistical approaches and calculated cut points for multiple datasets of ADA assays using the individual procedure employed at each laboratory.Conclusion:We showed that outlier exclusion, false-positive rate and investigating data distribution have the greatest impact on both screening and confirmatory cut points. Our results would be useful for industry researchers and regulators engaged in immunogenicity assessment of biopharmaceuticals. Aim: Methodology: Conclusion.
| 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), 06, Seite 509- |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Nishimura, Kazuko [VerfasserIn] |
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| Links: |
FID Access [lizenzpflichtig] |
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| Umfang: |
1 Online-Ressource (16 p) |
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| doi: |
10.4155/bio-2018-0178 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 520 | |a Aim:Appropriateness of anti-drug antibody (ADA) assay is critical for immunogenicity assessment of biopharmaceuticals. Although cut point setting in ADA assay has a large impact on the results, a standard statistical approach for its setting has not been well established.Methodology:In this multi-laboratory study, to elucidate factors influencing the cut point setting, we compared the statistical approaches and calculated cut points for multiple datasets of ADA assays using the individual procedure employed at each laboratory.Conclusion:We showed that outlier exclusion, false-positive rate and investigating data distribution have the greatest impact on both screening and confirmatory cut points. Our results would be useful for industry researchers and regulators engaged in immunogenicity assessment of biopharmaceuticals. Aim: Methodology: Conclusion | ||
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| 700 | 1 | |a Kadotsuji, Kenta |e verfasserin |4 aut | |
| 700 | 1 | |a Minoura, Kyoko |e verfasserin |4 aut | |
| 700 | 1 | |a Mori, Tamiki |e verfasserin |4 aut | |
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