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What are your experiences with the bioanalytical method
radioimmunoassay (as a competitive method).
At least four of every six QC samples in one analytical run should be
within 15 % of their respective nominal value (FDA guidance for
The rule is valid for HPLC and LC-MS/MS methods.
Is it acceptable to increase the limit on 20 % for the RIA due to the
higher scattering of the measured RIA results?
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