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RegisterICH M10 - Method validation - Anchoring points-reg [Regulatives / Guidelines]
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?.
Members can share their opinion
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?.
Members can share their opinion
Complete thread:
- ICH M10 - Method validation - Anchoring points-regryraman2661 2024-03-20 04:51 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- ICH M10 - Method validation - Anchoring points-reg Ohlbe 2024-03-20 10:50
- LBAs: Anchor points and model fitting Helmut 2024-03-21 17:42
- LBAs: Anchor points and model fitting ryraman2661 2024-03-25 12:28
Ing. Helmut Schütz