体内分析方法验证Bioanalytical Method Validation--FABIO GAROFOLO, PH.D.
Bioanalytical method validation is a procedure employed to demonstrate that an
analytical method used for quantification of analytes in a biological matrix is
reliable and reproducible to achieve its purpose: to quantify the analyte with a
degree of accuracy and precision appropriate to the task. Validation data, through
specific laboratory investigations, demonstrate that the performance of a method
is suitable and reliable for the analytical applications intended. The quantitative
approach used in bioanalytical methods involves the use of a standard curve
method with internal standard. In this approach the analyte concentration can
be assigned by referring the response to other samples, called calibrators or
calibration standards. In addition to the samples of unknown concentration, the
bioanalytical set includes the calibration standards, and samples containing no
analyte, called blanks, to assure that there are no interferences in the matrix.
Accuracy and precision of the method are calculated using the back-calculated
concentrations of samples of known composition called quality control samples
(QCs). The calibrator standards and quality control samples should be prepared
in the same matrix as the actual samples.
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