Plasma Protein Binding Assay

Plasma Protein Binding Assay

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Compliance

Non-GLP compliant. The study is best suited to quantify the bioavailability of test article.

Purpose of the Study

Determine the free vs. bound ratio of test article in human blood using an equilibrium dialysis assay.

Methodology

The equilibrium dialysis method uses an equilibrium dialysis device with an 8K molecular weight cut-off membrane to prevent proteins and protein-bound test article from crossing the dialysis membrane; serum remains on one side of the membrane while buffer and free test article crosses to the other side. Once provided with the concentration measurement results, IPST will calculate the percentage of free and protein-bound test article.

Parameters Monitored

Percentage free and bound test article following incubation in human serum.

Statistics

All data will be expressed as the mean ± standard error of the mean (S.E.M.).
Student’s t-tests will be used to verify statistical significance between various lots of the same material, or different test articles.

Amount of TA Required

To be specified based on the concentrations of test article to be used.

Study Timeline

  • Experimentation: 1 day
  • Shipping to sponsor: 2 days
  • Analysis by the sponsor or select analytical laboratory: TBD
  • Post-analysis calculations and reporting: 1 day