CORESTA Meeting, Smoke Science/Product Technology, 2013, Seville, ST 22

The statistical benefit of performing GLP bioanalysis using assays that have reduced variability

FARMEN R.H.; NEWLAND K.E.; GRAFF D.W.; COMBS M.L.
Celerion, Lincoln, NE, U.S.A.; Celerion, Zürich, Switzerland

Since the tobacco industry is moving into the area of regulated bioanalysis, we have noted that there is confusion surrounding the type of regulatory standards required for analytical methods to be used for testing tobacco constituents and biomarkers in biofluids. This presentation will focus on demonstrating the benefits of performing GLP bioanalysis by discussing the following bioanalytical topics:

  1. GLP – when is a study required to follow GLP guidelines and what constitutes a truly GLP study
  2. The importance of assuring sample integrity
  3. Critical elements of GLP method validation:
    1. Selectivity
    2. Sensitivity
    3. Carry-over and Contamination
    4. Accuracy & Precision
    5. Stability
  4. GLP standards are the cornerstone of bioanalytical chemistry. These principles are very different from clinical chemistry and GMP assays and include:
    1. Value of standards
    2. Relationship between standards and quality control samples
    3. Importance and timing of proper chromatographic integration
    4. Batch acceptance criteria
    5. Reporting sample concentrations
    6. Importance of incurred sample reproducibility

The benefit of performing GLP analysis for tobacco constituents and biomarkers is that the improved analytical precision which has a direct impact on statistical analysis. Specifically, more precise analytical methods allow studies to dose fewer subjects to achieve the same statistical power.