Terminalogy, and their explanations : terms used in bioanalytical mathod validation

Terminalogy, and their explanations : terms used in Bioanalytical mathod validation

Accuracy: The degree of closeness of the determined value to the nominal or known true value under prescribed conditions. This is sometimes termed trueness.

Analyte: A specific chemical moiety being measured, which can be intact drug, biomolecule or its derivative, metabolite, and/or degradation product in a biologic matrix.

Analytical run (or batch): A complete set of analytical and study samples with appropriate number of standards and QCs for their validation. Several runs (or batches) may be completed in one day, or one run (or batch) may take several days to complete.

Biological matrix: A discrete material of biological origin that can be sampled and processed in a reproducible manner. Examples are blood, serum, plasma, urine, feces, saliva, sputum, and various
discrete tissues.

Calibration standard: A biological matrix to which a known amount of analyte has been added or spiked. Calibration standards are used to construct calibration curves from which the concentrations of
analytes in QCs and in unknown study samples are determined.

Internal standard: Test compound(s) (e.g. structurally similar analog, stable labeled compound) added to both calibration standards and samples at known and constant concentration to facilitate quantification of the target analyte(s).

Limit of detection (LOD): The lowest concentration of an analyte that the bioanalytical procedure can reliably differentiate from background noise.

Lower limit of quantification (LLOQ): The lowest amount of an analyte in a sample that can be quantitatively determined with suitable precision and accuracy.

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.

Method: A comprehensive description of all procedures used in sample analysis.

Precision: The closeness of agreement (degree of scatter) between a series of measurements obtained from multiple sampling of the same homogenous sample under the prescribed conditions.

Processed: The final extract (prior to instrumental analysis) of a sample that has been subjected to various manipulations (e.g., extraction, dilution, concentration).

Quantification range: The range of concentration, including ULOQ and LLOQ, that can be reliably and reproducibly quantified with accuracy and precision through the use of a concentration-response relationship.

Recovery: The extraction efficiency of an analytical process, reported as a percentage of the known amount of an analyte carried through the sample extraction and processing steps of the method.

Reproducibility: The precision between two laboratories. It also represents precision of the method under the same operating conditions over a short period of time.

Sample: A generic term encompassing controls, blanks, unknowns, and processed samples, as described below:

1.Blank: A sample of a biological matrix to which no analytes have been added that is used to assess the specificity of the bioanalytical method.
2.Quality control sample (QC): 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.
3.Unknown: A biological sample that is the subject of the analysis.

Selectivity: The ability of the bioanalytical method to measure and differentiate the analytes in the presence of components that may be expected to be present. These could include metabolites,impurities, degradants, or matrix components.

Stability: The chemical stability of an analyte in a given matrix under specific conditions for given time intervals.

Standard curve: The relationship between the experimental response value and the analytical concentration (also called a calibration curve).

System suitability: Determination of instrument performance (e.g., sensitivity and chromatographic retention) by analysis of a reference standard prior to running the analytical batch.

Upper limit of quantification (ULOQ): The highest amount of an analyte in a sample that can be quantitatively determined with precision and accuracy.

Validation with respect to analytical method : Also see Pharmaceutical Process validation
1.Full validation: Establishment of all validation parameters to apply to sample analysis for the bioanalytical method for each analyte.

2.Partial validation: Modification of validated bioanalytical methods that do not necessarily call for full revalidation.

3.Cross-validation: Comparison validation parameters of two bioanalytical methods.

Bioanalytical mathod validation

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