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Analytical Considerations: Alfredo García - Arieta
Analytical Considerations: Alfredo García - Arieta
Types:
– Full validation: first time, new drug, or addition of metabolites
– Partial validation: modifications of a validated method
– Cross-validation: comparison between methods
Two of the six (33%) QC samples may be outside the 15% of their
respective nominal value, but not both at the same concentration
The data from rejected runs need not be documented, but the fact
that a run was rejected and the reason for failure should be
recorded