Validation of a Flow Cytometry Assay for Drug Response Evaluation
Author Information
Author(s): Timothy Wyant, Alan Lackey, Marie Green
Primary Institution: Millennium Pharmaceuticals, Cambridge, MA, USA
Hypothesis
The study aims to validate a flow cytometry-based chemokine internalization assay for evaluating the pharmacodynamic response to a receptor antagonist.
Conclusion
The validated assay demonstrated stability, sensitivity, and reproducibility, making it a reliable tool for assessing the pharmacodynamic effects of CCR2 antagonists in clinical trials.
Supporting Evidence
- The assay demonstrated a sensitivity to distinguish 0.005 μg/ml of a CCR2 antagonist with a %CV of 13.3%.
- Intra-assay repeatability was less than 15% with inter-assay repeatability of less than 20%.
- The assay reagent was stable over 26 weeks.
Takeaway
Researchers created a test to see how well a new drug works by measuring how it affects certain immune cells, and they found that the test is reliable and can be used in real studies.
Methodology
The assay was validated by examining reagent stability, robustness, sensitivity, repeatability, and reproducibility using whole blood from healthy volunteers.
Potential Biases
Potential sampling bias due to fewer individuals assessed at certain time points.
Limitations
The study's findings may be limited by the variability in donor responses and the small sample size for some time points.
Participant Demographics
108 healthy volunteers (54 receiving placebo, 54 receiving CCR2 antagonist).
Statistical Information
P-Value
0.15
Statistical Significance
p<0.05
Digital Object Identifier (DOI)
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