Article | REF: P224 V2

Validation of quantitative analytical methods by means of the accuracy profile

Author: Max FEINBERG

Publication date: December 10, 2012, Review date: May 23, 2023 | Lire en français

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    8. Conclusion

    The accuracy profile methodology has already been applied in a large number of applications (see the non-exhaustive list in the Need to know more section).

    A number of conclusions can be drawn from these examples.

    • The great generality of this approach. The list of methods that have been studied is already long: chromatography, spectroscopy, titrimetry, gravimetry, ELISA, PCR, microbiology, physics and so on.

    • In very general terms, if we take the definition of validation, the proposed approach follows exactly this definition: 1) start from the objectives to be achieved in terms of acceptability limits; 2) collect actual evidence through experimental designs; 3) then examine it statistically and graphically to confirm or invalidate validity.

    • The level-by-level profile...

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