ArticleThe AAPS journal2014
Ligand binding assay critical reagents and their stability: recommendations and best practices from the Global Bioanalysis Consortium Harmonization Team.
Article in The AAPS journal, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.
What it found
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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
16 citing papers in PubMed.
- Vendor-specific HRP antibody conjugate differences lead to unexpected immunoassay reagent interactions.Bioanalysis · 2026Article
- Strengthening Biomedical Research and Healthcare in Africa Through Localized Reagent Production.BioMed research international · 2026Review
- Review
- The case for calibration-free concentration analysis.Bioanalysis · 2025Article
- Article
- Neutralizing Antibody Sample Testing and Report Harmonization.The AAPS journal · 2024Article
- Review
- A comprehensive LC-MS based study of factors influencing biotinylation of critical reagents.Bioanalysis · 2024Article
- A Case Study for Critical Reagent Qualification for Ligand Binding Assays Using Equivalence Test Methodology.The AAPS journal · 2023Article
- Evaluation of the Humoral Response to Adeno-Associated Virus-Based Gene Therapy Modalities Using Total Antibody Assays.The AAPS journal · 2021Review
- Monoclonal Antibody Reagent Stability and Expiry Recommendation Combining Experimental Data with Mathematical Modeling.The AAPS journal · 2020Article
- Ensemble multicolour FRET model enables barcoding at extreme FRET levels.Nature nanotechnology · 2018Article
- Recommendations for Selection and Characterization of Protein Biomarker Assay Calibrator Material.The AAPS journal · 2017Article
- Recommendations for Use and Fit-for-Purpose Validation of Biomarker Multiplex Ligand Binding Assays in Drug Development.The AAPS journal · 2016Review
- Recommendations for validation of LC-MS/MS bioanalytical methods for protein biotherapeutics.The AAPS journal · 2015Article
- Introduction to the proposals from the global bioanalysis consortium harmonization team.The AAPS journal · 2014Article
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 L4 Global Harmonization Team on reagents and their stability focused on the management of critical reagents for pharmacokinetic, immunogenicity, and biomarker ligand binding assays. Regulatory guidance recognizes that reagents are important for ligand binding assays but do not address numerous aspects of critical reagent life cycle management. Reagents can be obtained from external vendors or developed internally, but regardless of their source, there are numerous considerations for their reliable long-term use. The authors have identified current best practices and provided recommendations for critical reagent lot changes, stability management, and documentation.
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Identifiers
What 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.