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  1. #1
    Validation Analyst
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    Smile LOD, LOQ as per ICH

    As per ICH guideline Q2(R1)
    6.3
    LOD =( 3.3 * Std. dev. of response) / Slope of calibration curve

    7.3

    LOQ =( 10 * Std. dev. of response) / Slope of calibration curve

    Please explain the methodology.
    Which calibration curve is to be used to get slope, is the linearity curve or any other?

    Again 6.3.3 & 7.3.3 talks about a specific calibration curve for sample in the range of DL & QL respectively. In that what is residual std. dev. of regression line or std. dev. of y-intercepts of regression lines may be used as std. dev.

    I did'nt understand it?

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  3. #2
    Validation Expert
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    I recommend you to read LCGC Oct 1998: determining limits of detection and quantitation, written by ira krull and michael swartz. there is an example ICH protocol in this article.

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