ArticleThe AAPS journal2026
Anti-drug Antibody Validation Testing and Reporting Harmonization Addendum.
Article in The AAPS journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Minimum Significant Ratio for Defining Treatment-Boosted ADA Responses Using Signal-to-Noise as an Alternative to Titer.The AAPS journal · 2026Article
- Advanced assay design for characterizing anti-drug antibody responses in clinical serum samples.Bioanalysis · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The anti-drug antibody validation testing and reporting harmonization (ADAH) white paper was published December 2021 and has generated significant interest, highlighting its utility within the scientific community. Following the ADAH white paper, members of the American Association of Pharmaceutical Scientist (AAPS) Therapeutic Product Immunogenicity community published a similar white paper addressing neutralizing antibody validation testing and reporting harmonization (NAbH) in July 2023 which has also been broadly accessed. Given the broad interest in these white papers by the bioanalytical and immunogenicity communities, the authors have solicited user feedback to address noted gaps. This feedback has prompted us to issue an addendum to address these gaps including adding a section on anti drug antibody (ADA) assay cross-validation and ADA data presentation for regulatory submissions, and to update the method sensitivity assessments. In addition, given recent year discussions around the implementation of signal to noise over titer, a section on this topic is included.
Indexed as
Identifiers
41507683What Socratic 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 Socratic graph.