Question: Bioanalytical repeat with different lab [Bioanalytics]

posted by jag009  – NJ, 2014-03-05 18:06 (4101 d 20:12 ago) – Posting: # 12563
Views: 4,594

Hi everyone,

Strange Question... Lets say I run clinical and bioanalytical at Lab A and the study fails. I have doubt about their analytical so I take the samples to another bioanalytical Lab "B". If the results from lab "B" are different and the study now passes, how do I go about justifying filing? Lets say both validation reports look good and the methods are acceptable.

Thanks,
John

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