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ICH Q2(R2) and ICH Q14 Analytical Validation
ICH Q2(R2) and ICH Q14 Analytical Validation
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Validation of Analytical Procedures
Q2(R2)
Analytical Procedure Development
Q14
ICH Q2R2 and ICH Q14 Objectives:
This guideline presents elements for consideration during the validation of analytical procedures included as part of registration applications. Analytical procedure validation forms a part of the analytical procedure lifecycle, as described within ICH Q14 Analytical Procedure Development.
ICH Q2(R2) provides guidance on selection and evaluation of the various validation tests for analytical procedures.
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