ICH M10 - Method validation - Anchoring points-reg [Regulatives / Guidelines]

posted by ryraman2661 – India, 2024-03-20 05:51 (23 d 09:32 ago) – Posting: # 23911
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Dear All,

I have a query with reference to the anchoring point(s) , (LLOQ and ULOQ) in method validation of normal, molecules.

As per the recent M-10 guideline, the criteria for accepting calibration curve is minimum 75 % of non-zero standards should pass. There is no mentioning of anchoring points.

In Precision and Accuracy (P & A) experiments.

We do 8 points calibrators including LLOQ and ULOQ and 6 replicates of each level QC. If one anchor point, ULOQ calibrator not meeting, and other 4 QCs are within the accepted calibrators, can we accept?.

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