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What to do if QC sample concentration doesn't fall within the desired range

EMEAvalidation bioanalytical method Analysis of study sample

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#1 lovelovecate



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Posted 25 November 2013 - 05:06 AM

EMEA: Guideline on bioanalytical method validation (2011) make a mention in page 12 " At least 2 QC sample levels should fall within the range of concentrations measured in study samples"


If I want to add 1 concentration level of QC samples to cover study samples, I will conduct a partial validation including a run including  a  calibration curve and a minimum of 5 samples (replcation) of QC sample. Is this way suitible? Or how can I do to fit this guideline? 


Please give me some suggection, thanks. 

#2 Curtis


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Posted 26 November 2013 - 08:57 PM

Have you tried doing that? or you are just about to? I think it's fine.

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