Only for QCs; encouraged ≠ required [Bioanalytics]

posted by Helmut Homepage – Vienna, Austria, 2020-08-01 14:13 (87 d 21:07 ago) – Posting: # 21816
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Hi dshah,

» If we consider the recent FDA guideline or ICH M10, i believe trend analysis for IS response, CC and QCs is also required.

Only for QCs and not required but encouraged (FDA page 30, ICH page 46).
However, Shuanghe’s batch passed the criteria and hence, possibly we will not see any trend of back-calculated concentrations. But of course, the shift in IS-responses is obvious.

@Shuanghe: Can you send me a file (CSV preferred) by PM with this columns?

injection, type of sample (containing B, Q, C, U), back-calculated concentration, IS response

I will upload it to have sumfink to play with. Bland-Altman plots might be an option. An idea: Set limits based on the one batch of the method validation which was performed in the anticipated maximum size of a run. If you have data of this batch, please give it as well.

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