Method validation is a process that demonstrates that a method will successfully
meet or exceed the minimum standards recommended in the Food and Drug
Administration (FDA) guidance for accuracy, precision, selectivity, sensitivity,
reproducibility, and stability. This article discusses the validation of bioanalytical
methods for small molecules with emphasis on chromatographic techniques.
Bioanalytical methods are used for the quantitation of drugs and their metabolites
in biological matrices. In today�s drug development environment, highly sensitive
and selective methods are required to quantify drugs in matrices such as blood,
plasma, serum, or urine. Chromatographic methods (high-performance liquid
chromatography [HPLC] or gas chromatography [GC] have been widely used for
the bioanalysis of small molecules, with liquid chromatography coupled to triple
quadrupole mass spectrometry (LC/MS/MS) being the single most commonly used
technology. After developing a method with desired attributes, the method is validated
to establish that it will continue to provide accurate, precise, and reproducible data
during study-sample analysis. The validation is performed using a control matrix
spiked with the compounds to be quantified. When validation begins, chances for
its successful completion (and more important, successful sample analysis) are
high. During method validation, values for validation parameters are obtained.
While obtaining above validation parameters, other parameters are also determined
during validation (eg, extraction efficiency, calibration range and response function
[linear or nonlinear], positional differences within an analytical run.
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