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Following established validation procedures is a necessary step to obtain regulatory approval to use a new analytical method, or to use an approved method in a new application The de nitions, methods, and parameters used to validate analytical and bioanalytical methods are not universal; they vary with the type of assay and the regulatory agency Here, we introduce the more broadly used gures of merit with their generally accepted de nitions Basic statistical procedures are also presented More technical sources of further information are offered in the Suggested Reading section Bioanalytical methods are classi ed according to the kind of results they provide Qualitative assays provide information about the presence or absence of the analyte, whereas quantitative assays give the analyte concentration and the uncertainty in this value, in the sample.

Semiquantitative methods give an estimate of concentration and are used to determine whether analyte is present at a level that is above or below a reference concentration; therefore the report can state if the concentration in the sample is higher, similar, or lower than the reference value 162 PRECISION AND ACCURACY Uncertainty is classi ed in two major groups: Random error is always present in experimental data and can never be completely eliminated It can result from the random nature of collisions that lead to chemical or biochemical reactions, or may be caused by small voltage uctuations in measurement instrumentation Random error causes positive and negative deviations from the true value, and affects the precision of the results Precision is usually discussed in terms of standard deviation (s) and relative standard deviation (RSD), both de ned later in this chapter.

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