Validation of a flow cytometry based chemokine internalization assay for use in evaluating the pharmacodynamic response to a receptor antagonist
2008

Validation of a Flow Cytometry Assay for Drug Response Evaluation

Sample size: 108 publication Evidence: high

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)

10.1186/1479-5876-6-76

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