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Reporting of LOD and LOQ in validation

Posted: Mon Mar 23, 2015 6:35 am
by jayroseville58
LOD and LOQ can be identified by standard deviation method and thru signal-to-noise ratio method. As per ICH guideline linearity for the RS method should be established from LOQ. Is it allowable that LOQ used here will be based from the S/N method while the values to be reported for the LOD and LOQ should be based from standard deviation method (derived from the linearity curve)? Thanks.

Re: Reporting of LOD and LOQ in validation

Posted: Sun Apr 26, 2015 6:08 am
by Alfred88
There are several approaches to estimate LOD or LOQ. If you have data, you can construct a linear curve of standards, then calculate (estimate) LOD using standard deviation of intercept.
Then you can prepare solution at the target LOD to confirm your estimate.
Alfred.