analytical procedure
- Guideline or reference source
- ICHM10 Bioanlytical Method Validation
- ICHQ2 Validation of analytical procedures
- Definition
- The analytical procedure refers to the way of performing the analysis. It should describe in detail the steps necessary to perform each analytical test. This may include but is not limited to: the sample, the reference standard and the reagents preparations, use of the apparatus, generation of the calibration curve, use of the formulae for the calculation, etc.
- Related Term
- acceptance criteria
- accuracy
- analytical data
- detection limit
- limit of detection
- linearity
- process analytical technology
- quantitation limit
- range
- robustness
- specific test
- specification
- universal test
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