Case Study: Requirements for analytical method development and validation
|Accuracy||Closeness of agreement between the average value obtained from a large series of test results and an accepted reference value|
|Precision||Expresses the closeness of agreement between a series of measurements obtained from multiple sampling of the same homogenous sample|
|Specificity||The ability to assess indisputably the target analyte in the presence of components which may be expected to be present (such as impurities)|
|Limit of Detection (LOD)||The lowest amount of analyte in the sample which can be detected but not necessarily quantified as an exact value|
|Limit of Quantification||The lowest amount of analyte in the sample which can be quantitatively determined with suitable precision and accuracy|
|Linearity||The ability (within a given range) to obtain test results which are directly proportional to the concentration (amount) of the analyte in the sample|
|Range||The interval between the upper and lower concentration (amounts) of analyte in the sample for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity|
|Robustness||Shows the reliability of an analysis with respect to deliberate variations in method parameters|
|Stability||The degree to which the substance is subject to degradation in time|
Purpose of ValidationIf we get a positive result: To be able to conclude with confidence that the target analyte is present in the sample at or above the legal limitIf we get a negative result: To be able to conclude with confidence that if the analyte is present at all then it must be below the legal limit or undetectable at ‘as low as reasonable achievable’ (ALARA).
What we would like you to doPlease answer the following questions in the comments section below:
- Have you any experience in a laboratory or testing analytical methods for any of these performance characteristics?
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