TSRC, Tob. Sci. Res. Conf., 2012, 66, abstr. 41

Fit for purpose bioanalytical validation and sample processing

Celerion, Lincoln, NE, USA

Since the tobacco industry is moving into the area of regulated bioanalysis we have noted that there is a lot of confusion surrounding fit-for-purpose bioanalytical methods. Additionally, there are many bioanalytical guidances from different regulatory agencies that sometimes seem to contradict each other. Celerion is a CRO that has a long history of regulated bioanalytical expertise. This presentation will focus on explaining the following bioanalytical topics with a focus on compliance:

  1. GLP – when is a study truly GLP, and when does a study follow GLP guidelines?
  2. The importance of assuring sample integrity.
  3. An analytical batch; this is the cornerstone of bioanalytical chemistry and its principles are very different from clinical chemistry and GMP assays.
    1. The value of standards
    2. The relationship between standards and quality control samples
    3. The importance and timing of proper chromatographic integration
    4. The various types of regression parameters used to define a batch
    5. Batch acceptance criteria
    6. Dilution integrity
  4. The importance of incurred sample reproducibility will be explored.
  5. A proper way to report sample concentrations will be discussed

Depending upon the type of study and how the results will be used determines which criteria and which tests need to be performed to make the method “fit-for-purpose.” How a “fit-for-purpose” method will be used must be defined a priori.