Trial reportJournal of translational medicine2008
Validation of a flow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist.
Trial report in Journal of translational medicine, 2008. 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.
- A cell based assay for evaluating binding and uptake of an antibody using hepatic nonparenchymal cells.Scientific reports · 2021Article
- Validation of a flow cytometry based binding assay for evaluation of monoclonal antibody recognizing EGF receptor.Scientia pharmaceuticaArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmacodynamic assays are important in clinical trial design to investigate the relationship between drug concentration (pharmacokinetics) and drug "effect' or biological activity. Increasingly flow cytometry is being used to examine the pharmacodynamic effect of new drug entities. However, to date, the analytical validation of cytometry based assays is limited and there is no suitable guidance for method validation of flow cytometry-based pharmacodynamic assays. Here we report the validation of a flow cytometry-based chemokine internalization assay for use in evaluating the effect of a receptor antagonist in clinical trials. The assay method was validated by examining the stability of the reagent, assay robustness, sensitivity, repeatability and reproducibility precision. Experimental results show the assay reagent was stable over 26 weeks. The assay demonstrated a sensitivity to distinguish 0.005 microg/ml of a CCR2 antagonist with a %CV of 13.3%. The intra-assay repeatability was less than 15% with an inter-assay repeatability of less than 20%. In vivo study results demonstrated that the assay was consistent and a reliable measure of antagonist activity.
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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.