range
- Guideline or reference source
- ICHQ2 Validation of analytical procedures
- Definition
- The range of an analytical procedure is the interval between the upper and lower concentration (amounts) of analyte in the sample (including these concentrations) for which it has been demonstrated that the analytical procedure has a suitable level of precision, accuracy and linearity.
- Broader Term
- validation parameters
- Related Term
- accuracy
- analytical procedure
- detection limit
- linearity
- precision
- quantitation limit
- robustness
- specificity
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