ArticleBioanalysis2024
The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays.
Article in Bioanalysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- ADA assays for high-dose biologics: redefining drug tolerance through clinical insights.Bioanalysis · 2026Article
- Rethinking immunogenicity: an integrated approach reveals the PK/PD impact of pre-existing and drug-sustaining ADA.Bioanalysis · 2026Article
- Revisiting the Anti-Drug Antibody Assay Drug Tolerance of a Commercial Biological Product.The AAPS journal · 2025Article
- Improving sensitivity and drug tolerance of assays for neutralizing anti-drug antibodies to semaglutide and native GLP-1.Bioanalysis · 2025Article
- Impact of drug concentration and ADA assay drug tolerance on the assessment and correlation of titer and signal to noise.Bioanalysis · 2025Article
- Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum.Bioanalysis · 2025Article
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The European Bioanalysis Forum, in collaboration with several key industry stakeholders, has recently led discussions that address international immunogenicity guidance documents, specifically the three tier approach for immunogenicity testing strategies, after more than 20 years of experience with biotherapeutics. As part of this, the strategy and methods used to assess drug tolerance across all immunogenicity assays are challenged, emphasizing that bioanalytical scientists need to consider the context-of-use of each assay. Here, recommendations for drug tolerance assessments, driven by strong scientific rationale and subject to reevaluation as needed, are provided. This includes carefully considering the drug and positive control concentrations considered to be appropriate and which tiers are most relevant for performing drug tolerance assessments.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.