ArticleThe AAPS journal2024
A Data Driven Strategy for Implementation of Singlicate Analysis in Ligand Binding Assays Used for the Determination of Anti-drug Antibodies to a Multidomain Biotherapeutic.
Article in The AAPS journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
5 citing papers in PubMed.
- Immunogenicity assessment for vidutolimod: a risk-driven approach for a simplified 1-tiered, singlicate anti-drug antibody testing strategy.Frontiers in immunology · 2026Article
- Substantial Comparability of Singlicate Versus Duplicate Analysis-A Retrospective Evaluation of Clinical Immunogenicity in a Biosimilar PK Study.The AAPS journal · 2025Article
- Evaluation of singlicateBioanalysis · 2025Article
- Evaluation of Anti-SARS-CoV-2 IgG Responses in a Clinical Study of a Biosimilar Candidate to Denosumab Using Singlicate Analysis.Drugs in R&D · 2025Article
- Singlicate analysis in ADA assays: comparing assay performance in duplicate and singlicate formats.Bioanalysis · 2025Review
Corrections and comments
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A stepwise, data-driven approach for Anti-Drug Antibodies (ADA) singlicate assays has been developed to evaluate the feasibility of singlicate ligand binding assay (LBA) method development, qualification and validation to support our clinical programs. With initial precision runs in method validation and subsequent statistical analysis to directly compare duplicate and singlicate formats, our results indicated no meaningful difference in assay precision between duplicate and singlicate. Consequently, the rest of the ADA method validation proceeded with singlicate analysis yielding acceptable validation results. The validated ADA assay in singlicate has been employed to support a Phase I study. The appropriateness of singlicate analyses is further supported by Signal-to-Noise (S/N) data from the three tiers of the confirmatory positive samples, which showed strong correlation in S/N values.
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39562377What OpenQuestion holds
Registered trials
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.