LOD, LOQ as per ICH

GOOD VALIDATION PRACTICE (cGVP) LABORATORY, METHOD AND ANALYTICAL VALIDATION
1

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?

2

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.