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European Pharmaceutical Contractor
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The term 'validated assay' is frequently used to justify the veracity of analytical data. The guarantee that this terminology provides depends upon the nature and extent of validation, which in turn is dependent upon the application of the data. Is the data to be used for definitive pharmacokinetics/pharmacodynamics? Is it to be used as a clinical indicator of a diseased state, or for identifying/stratifying different disease populations and/or the likelihood of response to different therapies? The different validation criteria are discussed with relevance to the application of different assays.
Validating Analytical Methods
The term validation is widely used and is often misunderstood as it can provide a false sense of security. Generally it applies to the requirement to characterise or evaluate the performance of an analytical method with respect to defining its response function, such as a standard curve. The parameters of precision, accuracy, sensitivity and selectivity (specificity) are frequently referred to as the PASS criteria. In addition the stability of the analyte, although not a characteristic of the assay, is certainly a function of the analyte and the method used, and should be determined as soon as possible.
Validation is considered in some cases to be a one-occasion event. However, this is not so and additional validation may be needed in response to a number of changes. For example, this can be caused by changes in sample collection conditions, dietary issues, health status, sex, sampling times (diurnal variations), method material, analyst, anticoagulants and so on. Usually performance characteristics are set to define the proposed application.
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