A Guide to Analytical Method Development: Part 2

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Qualification Phase

The qualification phase assists in establishing early preliminary acceptance criteria.

Recommended qualification parameters:

  • Specificity: Specific evaluation of a test component or reference sample while in the presence of other components.
  • Accuracy: Closeness or exactness between an accepted true value and an accepted reference value.
  • Linearity: Ability to obtain test results directly proportional to concentration/amount of analyte.
  • Range: Interval between the UPPER and LOWER concentration/amount of analyte.
  • Limit of Detection: Lowest concentration/amount in a test component that CAN BE DETECTED but NOT QUANTIFIED.
  • Limit of a Quantitation: Lowest concentration/amount in a test component that CAN BE QUANTIFIED.
  • Precision Repeatability: Precision under the same operating conditions over a short interval of time.
  • Robustness: Measure of its capacity to remain unaffected by small but deliberate variations in method parameters.

Learn more about the Qualification phase of Analytical Development in the infographic.

Pharmatech Associates can assist you in setting up the parameters that will make up your drug’s qualification phase. Contact us today!

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