DEFINITIONS

DEFINITIONS
Anchor calibrators
Anchor calibrators are standards points outside of the range of quantitation, used to assist in fitting the non linear regression of the standard curve in ligand-binding assays.
2.
Accuracy
The accuracy of an analytical procedure expresses the closeness of the determined value to the value which is accepted either as a conventional true value or an accepted reference value.
3.
Analytical Procedure
The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analysis.
4.
Calibration range
The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure meets requirements for precision, accuracy and response function.
5.
Carry over
Carry-over is the appearance of an analyte signal in blank sample peaks after the analysis of samples with a high analyte concentration.
6.
Incurred samples
Study samples from dosed subjects or animals.
7.
Incurred sample reanalysis
The analysis of a portion of the incurred samples to determine whether the original analytical results are reproducible.
8.
Lower limit of quantitation (LLOQ)
The lower quantitation limit of an individual analytical procedure is the lowest amount of analyte in a sample which can be quantitatively determined with pre-defined precision and accuracy.
9.
Matrix effect
The direct or indirect alteration or interference in response due to the presence of unintended analytes (for analysis) or other interfering substances in the sample.
10.
Precision
The precision of an analytical procedure expresses the closeness of agreement (degree of scatter) between a series of measurements obtained under the prescribed conditions.
11.
Quality control (QC) sample
A spiked sample used to monitor the performance of a bioanalytical method and to assess the integrity and validity of the results of the unknown samples analyzed in an individual batch.
12.
Response function
The response function of an analytical procedure is its ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of analyte in the sample.
13.
Selectivity
Selectivity is the ability of the bioanalytical method to measure and differentiate the analyte in the presence of components which may be expected to be present.
Specificity
For ligand binding assays, specificity is the ability to measure the analyte unequivocally in the presence of other compounds, either exogenous or endogenous, in the matrix.
15.
Upper limit of quantitation (ULOQ)
The upper quantitation limit of an individual analytical procedure is the highest amount of analyte in a sample which can be quantitatively determined with pre-defined precision and accuracy.