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Group 2:Typical analytical parameters in method validation (ketua: Hakim)
Group 2:Typical analytical parameters in method validation (ketua: Hakim)
Specificity
Ability to asses unequivocally the analyte in presence of componants which may be expected to be present.
-used to demonstrate the specificity will depend on the intended objective of the analytical procedure
VALIDATION MEANING
a process of establishing a documented evidence that a specific process will consistently produce a product
Detection Limit
the lowest amount of analyte in a sample which can be detected but not necessarily quantitated
Quantitation Limit
the degree of agreement among individual test result when the method is applied repeatedly to multiple sampling of a homogeneous sample
Precision
Degree of agreement among individual test result when the method is applied repeating to multiple sampling of homogenous sample
Range
The interval between the upper and lower concentration (amount) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has suitable level of precision, accuracy and linearity.
Linearity
Ability ( within a given range ) to obtain test results which are directly proportional to the concentration ( amount) of analyte in the sample.
Rubustness
Measure of its capacity to remain unaffected by small,but deliberate variations method parameters and provides an indication of its reliability during normal usage.
Accuracy
Closeness of test result obtained by that method to the true value.