Robust Considerations

Dartboard with darts
  • Specificity/Selectivity - The ability to assess unequivocally the analyte in the presence of components which may be expected to be present.
  • Accuracy/Precision - The closeness of agreement and degree of scatter between the true value and the value found.
  • Repeatability - The precision under the same operating conditions over a short interval of time.
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  1. If stability testing indicates that the product or a reagent used during the qualification/validation study is particularly sensitive to time in solution, then consideration should be given to investigating the preparation to analysis time.
  2. If the method utilises third party consumables then testing different lots should be considered.
  3. If the method uses re-usable technologies such as columns, cartridges and capillaries, are the results impacted by the usage rate of said consumables?
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